Kombigliz prolong (Kombiglyze prolong) - kev thov kev qhia

Thoob ntiaj teb lub npe:Kombiglyze ntev

Kev Sib Sau thiab daim ntawv ntawm kev tso tawm

Zaj Duab Xis Tso Daim Qauv Duab Tsoo Tso Tawm. 1 ntsiav tshuaj muaj 1000 mg ntawm metformin, 2.5 mg ntawm saxagliptin.

Hauv hlwv 28 lossis 56 ntsiav tshuaj. Ntim rau hauv thawv ntawv thawv.

Zaj duab xis-hloov kho cov ntsiav tshuaj tso tawm, 1000 mg + 5 mg. Hauv pob ntawm 28 lossis 56 ntsiav tshuaj.

Zaj duab xis-hloov kho cov ntsiav tshuaj tso tawm, 500 mg + 5 mg. Hauv pob ntawm 28 lossis 56 ntsiav tshuaj.

Cov chaw soj ntsuam thiab chaw muag tshuaj

Tshuaj qhov ncauj hypoglycemic

Cov tshuaj pab pawg kho mob

Sib xyaw hypoglycemic tus neeg sawv cev rau kev tswj hwm ntawm qhov ncauj (dipeptidyl peptidase-4-inhibitor + biguanide)

Pharmacological kev txiav txim

Combogliz Prolong muab ob lub tshuaj hypoglycemic nrog sib xyaw ua ke ntawm kev nqis tes ua txhawm rau txhim kho glycemic tswj nyob rau hauv cov neeg mob uas muaj hom 2 mob ntshav qab zib mellitus (DM2): saxagliptin, dipeptyl peptidase 4 inhibitor (DPP-4), thiab metformin, tus sawv cev ntawm chav kawm biguanide.

Hauv kev teb rau kev noj zaub mov los ntawm cov hnyuv me, cov tshuaj hormones ntau ntxiv tso rau hauv cov ntshav, xws li glucagon-zoo li peptide-1 (GLP-1) thiab glucose-dependant insulinotropic polypeptide (HIP). Cov tshuaj hormones no txhawb lub cev tawm ntawm insulin los ntawm pancreatic beta hlwb, nyob ntawm qhov kev saib xyuas ntawm cov piam thaj hauv cov ntshav, tab sis tsis ua li cas los ntawm enzyme DPP-4 rau ob peb feeb. GLP-1 kuj tseem qis qis qhov zais cia ntawm glucagon hauv cov roj ntsha alp hauv hlwb, txo cov ntshav qabzib ntau lawm. Hauv cov neeg mob uas muaj ntshav qab zib hom 2, qhov kev tso tawm ntawm GLP-1 tsawg dua, tab sis qhov tshuaj insulin rau GLP-1 tseem nyob. Saxagliptin, yog qhov muaj kev sib tw txhim kho ntawm DPP-4, txo qhov tsis muaj txiaj ntsig ntawm cov tshuaj hormones incretin, yog li ua rau lawv cov kev nkag siab hauv cov hlab ntshav thiab ua rau txo qis ntawm cov piam thaj tom qab noj mov.

Metformin yog hom tshuaj hypoglycemic uas txhim kho cov kua nplaum ua haujlwm rau cov neeg mob ntshav qab zib hom 2, txo qis qis thiab tom qab cov ntshav qabzib feem ntau. Metformin txo qhov tsim tawm ntawm cov piam thaj los ntawm lub siab, txo qis kev nqus ntawm cov piam thaj hauv cov hnyuv thiab nce insulin rhiab heev, ua kom muaj qhov nqus ntau ntxiv thiab kev siv cov kua nplaum nyob. Tsis zoo li sulfonylurea kev npaj, metformin tsis ua rau cov ntshav qog ntshav qab zib hauv cov neeg mob ntshav qab zib hom 2 lossis cov neeg muaj mob noj qab haus huv (tshwj tsis yog muaj xwm txheej tshwj xeeb, saib rau cov nqe lus "Kev Ceeb Toom" thiab "Cov Lus Qhia Tshwj Xeeb"), thiab hyperinsulinemia. Thaum lub sij hawm kho cov tshuaj metformin, cov tshuaj insulin tsis hloov, txawm hais tias yoo insulin ceev thiab cov lus teb rau cov pluas noj thaum nruab hnub yuav tsawg zuj zus.

Cov Tshuaj Pharmacokinetics

Cov tshuaj pharmacokinetics ntawm saxagliptin thiab nws cov metabolite, 5-hydroxy-saxagliptin, zoo ib yam li cov neeg ua haujlwm noj qab haus huv thiab hauv cov neeg mob ntshav qab zib hom 2. Cov txiaj ntsig ntawm C max thiab thaj chaw hauv qab AUC nkhaus ntawm saxagliptin thiab nws cov nquag metabolite hauv plasma nce raws qib hauv cov koob tshuaj ntau npaum li ntawm 2.5 mg txog 400 mg. Tom qab ib qho kev tswj hwm qhov ncauj ntawm saxagliptin ntawm koob tshuaj 5 mg los ntawm cov neeg ua haujlwm noj qab haus huv, qhov nruab nrab ntawm AUC qhov tseem ceeb ntawm saxagliptin thiab nws cov metabolite tseem ceeb yog 78 ng * h / ml thiab 214 ng * h / ml, thiab C qhov tseem ceeb hauv plasma yog 24 ng / ml thiab 47 ng / ml raws li. Qhov nruab nrab txawv ntawm AUC thiab C max ntawm saxagliptin thiab nws cov metabolite nquag tau tsawg dua 25%.

Nrog kev siv cov tshuaj ib zaug ib hnub nyob rau ib qho tshuaj twg, tsis muaj ib qho pom tseeb zuj zus ntawm saxagliptin lossis nws cov metabolite. Tsis muaj ib qho kev vam khom ntawm kev ua kom huv ntawm saxagliptin thiab nws cov metabolite ntawm lub koob tshuaj thiab lub sijhawm thaum thov rau 14 hnub ib hnub ib zaug hauv kev noj tshuaj los ntawm 2.5 mg txog 400 mg ntawm saxagliptin.

Nrog max, metformin hloov kho tso tawm tau tiav nyob rau hauv nruab nrab ntawm 7 teev. Qhov nqus ntawm metformin los ntawm hloov kho cov ntsiav tshuaj nce ntxiv kwv yees li 50% thaum noj nrog zaub mov. Ntawm kev sib npaug, AUC thiab Cmax ntawm metformin hloov kho tso tawm tsis nce raws feem ntau ntawm cov koob tshuaj ntau npaum li cas ntawm 500 txog 2000 mg. Tom qab rov ua dua ntawm thawj coj, metformin hloov kho tso tawm tsis tsim hauv plasma. Metformin raug ntuav tawm tsis hloov pauv los ntawm ob lub raum thiab tsis muaj tshuaj lom hauv lub siab.

Tom qab lub qhov ncauj tswj hwm, tsawg kawg 75% ntawm koob tshuaj saxagliptin yog nqus tau. Noj mov tsis muaj kev cuam tshuam loj heev rau pharmacokinetics ntawm saxagliptin hauv cov neeg tuaj noj qab haus huv zoo. Cov zaub mov ua rog siab tsis cuam tshuam C max ntawm saxagliptin, thaum AUC nce 27% piv nrog kev yoo mov. Lub sijhawm nce mus txog C max (T max) rau saxagliptin nce ntxiv kwv yees li 0.5 teev thaum noj tshuaj nrog zaub mov tab sis muab piv nrog yoo. Txawm li cas los xij, cov kev pauv hloov no tsis yog qhov tseem ceeb hauv tsev kho mob.

Tom qab ib qhov ncauj tswj hwm ntawm metformin hloov kho tso tawm, C max ua tiav ntawm qhov nruab nrab tom qab 7 teev, hauv thaj tsam li ntawm 4 txog 8 teev. AUC thiab Cmax ntawm metformin hloov kho tso tawm tsis nce raws feem ntau rau cov tshuaj ntau npaum li cas ntawm 500 txog 2000 mg. Qhov siab tshaj plaws ntawm cov tshuaj hauv cov ntshav ntshav yog 0.6, 1.1, 1.4 thiab 1.8 μg / ml thaum noj cov koob tshuaj 500, 1000, 1500 thiab 2000 mg ib hnub ib zaug, ntsig txog. Txawm hais tias qhov kev ntsuas ntawm kev nqus (ntsuas los ntawm AUC) ntawm metformin los ntawm kev hloov pauv cov tshuaj metformin nce ntxiv kwv yees li 50% thaum noj nrog zaub mov, kev noj zaub mov tsis cuam tshuam C max thiab T max ntawm metformin. Cov zaub mov noj qis thiab muaj roj ntau hauv lub cev muaj qhov zoo tib yam ntawm cov tshuaj muaj txiaj ntsig ntawm qhov hloov kho tso tawm metformin.

Kev khi ntawm saxagliptin thiab nws lub ntsiab metabolite rau cov ntshav cov protein tsis tseem ceeb, yog li, tuaj yeem xav tias kev faib tawm saxagliptin nrog kev hloov pauv ntawm cov protein sib xyaw ntawm cov ntshav pom nyob rau hauv hepatic lossis lub raum tsis ua haujlwm yuav tsis raug hloov pauv tseem ceeb.

Cov kev tshawb fawb txog kev faib tawm cov metformin hloov kho tsis tso tawm, txawm li cas los xij, qhov pom tseeb ntawm kev faib tawm ntawm cov metformin tom qab ib leeg tso qhov ncauj ntawm metformin tam sim ntawd tso cov ntsiav tshuaj ntawm ib koob 850 mg qhov nruab nrab 654 ± 358 L. Metformin ib nyuag khi rau cov ntshav protein.

Saxagliptin yog metabolized feem ntau nrog kev koom tes ntawm isoenzymes ntawm cytochrome P450 ZA4 / 5 (CYP3A4 / 5) nrog kev tsim cov nquag metabolite, cov nyhuv inhibitory uas tiv thaiv DPP-4 yog 2 lub sijhawm tsis muaj zog tshaj li ntawm saxagliptin.

Cov kev tshawb fawb nrog kev tso tawm ib leeg ntawm cov tshuaj rau cov neeg ua haujlwm pab dawb noj qab haus huv pom tias metformin raug nteg tawm tsis hloov los ntawm lub raum, tsis yog cov tshuaj tiv thaiv hauv lub siab (metabolites tsis kuaj hauv tib neeg), thiab tsis raug tawm hauv cov hnyuv.

Saxagliptin raug cais tawm los ntawm lub raum thiab hauv cov hnyuv. Tom qab ib koob tshuaj 50 mg ntawm daim ntawv lo 14 C-saxagliptin, 24% ntawm cov koob tshuaj tau raug tso tawm los ntawm lub raum ua qhov hloov pauv saxagliptin thiab 36% yog cov tshuaj metabolite ntawm saxagliptin. Cov tshuaj tiv thaiv kab mob tag nrho hauv cov zis ntsuas rau 75% ntawm kev noj tshuaj.

Qhov nruab nrab lub raum tshem tawm ntawm saxagliptin yog kwv yees li 230 ml / min, qhov nqi nruab nrab ntawm glomerular pom tau yog li 120 ml / min. Rau lub ntsiab metabolite, lub raum tshem tawm tau sib piv nrog lub txiaj ntsig tseem ceeb ntawm glomerular pom. Txog 22% ntawm tag nrho cov xov tooj cua tau pom nyob hauv cov quav.

Cov hlaws hlaws hlaws muaj kwv yees li 3.5 npaug siab dua ntawm creatinine qhov kev tshem tawm (CC), uas qhia tau tias tubular zais zis yog txoj kev tseem ceeb ntawm kev nthuav tawm ntawm metformin.Tom qab kev tswj hwm ntawm qhov ncauj, kwv yees li 90% ntawm cov tshuaj nqus tau zoo dhau los ntawm lub raum thaum thawj 24 teev, nrog ib nrab-lub neej los ntawm ntshav ntawm kwv yees li 6.2 teev. Hauv cov ntshav, ib nrab-lub neej yog kwv yees li 17.6 teev, yog li ntawd, lub qe ntshav liab loj tuaj yeem yog ib feem ntawm txoj kev faib khoom.

Pharmacokinetics hauv cov chaw kho mob tshwj xeeb

Nws tsis pom zoo kom siv Combogliz Prolong hauv cov neeg mob uas mob raum tsis ua haujlwm (saib Ntu "Kev Tshawb Nrhiav Pov Tseg").

Hauv cov neeg mob uas tsis tshua mob lub raum, AUC qhov tseem ceeb ntawm saxagliptin thiab nws cov metabolite yog 20% thiab 70% (feem ntau) siab dua AUC qhov tseem ceeb hauv cov neeg mob uas lub raum tsis ua haujlwm. Txij li qhov nce hauv tus nqi no tsis suav tias yog kev kho mob tseem ceeb, nws tsis pom zoo kom hloov cov tshuaj saxagliptin hauv cov neeg mob uas tsis mob ntsws tsis zoo.

Hauv cov neeg mob uas lub raum tsis ua haujlwm (raws li cov txiaj ntsig ntawm QC kev ntsuas), ib nrab-lub neej ntawm metformin los ntawm ntshav thiab cov ntshav tawm thiab cov ntshav lub raum ua kom tsawg dua nyob rau hauv kev faib ua feem rau QC.

Hauv cov neeg mob uas tsis tshua muaj mob me me, mob nyhav thiab hnyav hnyav, tsis muaj kev hloov pauv ntau hauv cov chaw muag tshuaj ntawm saxagliptin, yog li kev kho kom haum rau cov neeg mob zoo li no tsis tas yuav ua.

Tsis muaj kev tshawb fawb pharmacokinetic ntawm metformin hauv cov neeg mob uas muaj mob rau daim siab tsis xws luag.

Kev kho ntawm ib koob tshuaj saxagliptin nyob ntawm tus tub los ntxhais ntawm tus neeg mob tsis tas yuav.

Hauv kev tshawb fawb soj ntsuam hauv cov neeg mob uas muaj ntshav qab zib hom 2, cov nyhuv ntshav qab zib ntau npaum li cas ntawm metformin hauv txiv neej thiab poj niam tau sib piv.

Hauv cov neeg mob 65-80 xyoo, tsis muaj qhov sib txawv hauv cov chaw muag tshuaj ntawm saxagliptin piv nrog cov neeg mob uas muaj hnub nyoog yau dua (18-40 xyoo), yog li ntawd yuav tsum tau txhaj tshuaj rau cov neeg laus laus tsis tas yuav tsum tau txhaj. Txawm li cas los xij, nws yuav tsum tau yug los rau hauv lub siab tias hauv pawg no ntawm cov neeg mob, qhov kev txo qis ntawm lub raum ua haujlwm ntau dua (saib ntu "Noj thiab Tswj Xyuas" thiab "Cov Lus Qhia Tshwj Xeeb").

Tsuas siv cov ntaub ntawv los ntawm kev tshawb fawb soj ntsuam ntawm pharmacokinetics ntawm metformin hauv kev noj qab haus huv laus laus hais tias tag nrho cov ntshav ua kom meej meej ntawm metformin poob qis, T 1/2 nce, thiab C max nce piv rau qhov tseem ceeb ntawm cov kev txwv no hauv cov tub ntxhais hluas noj qab haus huv zoo. Raws li cov ntaub ntawv no, kev hloov pauv hauv cov khw muag tshuaj ntawm metformin nrog rau lub hnub nyoog nce ntxiv yog vim muaj kev hloov pauv hauv lub raum kev ua haujlwm. Combogliz Prolong yuav tsum tsis txhob raug rau cov neeg mob hnub nyoog tshaj 80 xyoo, tshwj tsis yog thaum lub raum zoo li qub tau lees paub los ntawm QC cov txiaj ntsig.

Kev tshawb fawb ntawm cov tshuaj pharmacokinetics ntawm saxagliptin hauv cov menyuam yaus tsis tau ua.

Cov kev tshawb fawb ntawm pharmacokinetics ntawm metformin hloov kho tso tawm hauv cov menyuam yaus tsis tau ua.

Haiv neeg thiab Pab pawg

Nws tsis pom zoo kom kho qhov koob tshuaj saxagliptin nyob ntawm tus neeg mob haiv neeg.

Muaj tsis muaj kev tshawb fawb ntawm cov khw muag tshuaj ntawm metformin nyob ntawm seb haiv neeg twg ntawm cov neeg mob.

Hom 2 mob ntshav qab zib mellitus ua ke nrog kev noj haus thiab qoj ib ce kom txhim kho glycemic tswj.

Cov Txheej Txheem Txuas Rau Siv Tshuaj Qaug Combogliz Prolong

Ua rau cov tib neeg muaj kev cuam tshuam rau ib feem twg ntawm cov tshuaj, cov tshuaj tiv thaiv mob ntshav qab zib tsis haum (anaphylaxis lossis angioedema) rau DPP-4 cov tshuaj tiv thaiv kab mob ntshav qab zib, hom 1 mob ntshav qab zib mellitus (siv tsis tau kawm), siv nrog insulin (tsis kawm), ua tsis haum ntshav tsis haum, lactase deficiency thiab piam thaj-galactose malabsorption, cev xeeb tub, lactation, hnub nyoog qis dua 18 xyoo (kev nyab xeeb thiab kev kawm tsis tau zoo), lub raum tsis ua haujlwm (cov kab mob creatinine ≥1.5 mg / dl rau cov txiv neej, ≥1.4 mg / dl rau cov poj niam cystin lossis txo tus kabmob creatinine tshem tawm), suav nrog cov mob los ntawm kev mob plawv tsis ua haujlwm (poob siab), mob myocardial infarction thiab septicemia, mob hnyav uas muaj kev pheej hmoo ntawm lub raum tsis ua haujlwm: lub cev qhuav dej (nrog rau ntuav, raws plab),kub ib ce, mob hnyav, kis tau los ntawm hypoxia (poob siab, mob sepsis, mob raum, mob voos, mob ntshav qab zib), nrog rau ketoacidosis uas mob ntshav qab zib, nrog lossis tsis hnovqab, ua rau muaj kev mob loj heev uas tuaj yeem ua rau mob siab thiab mob ntev tuaj yeem ua rau kev txhim kho ntawm cov nqaij mos hypoxia (ua pa tsis ua haujlwm, lub plawv tsis ua haujlwm, mob myocardial infarction), kev phais mob hnyav thiab mob nyhav (thaum insulin txoj kev kho tau qhia), lub siab ua haujlwm tsis zoo. kev haus dej cawv thiab mob ncauj lus lom, lactic acidosis (suav nrog keeb kwm), lub sijhawm tsawg kawg 48 teev ua ntej thiab tsis pub dhau 48 teev tom qab kev tshawb fawb radioisotope lossis radiological nrog kev qhia txog iodine-muaj cov tshuaj tiv thaiv tsis zoo, ua raws li cov zaub mov tsis muaj calorie (5% ntawm cov neeg mob, cov neeg uas tau txais hloov kho tshaj tawm metformin thiab txhim kho ntau dua li ntawm cov pab pawg placebo yog zawv plab thiab xeev siab / ntuav.

Cov kev mob tshwm sim hauv qab no tau tshaj tawm lub sijhawm tshaj tawm tom qab kev siv tshuaj saxagliptin: kev mob nrawm thiab mob lub cev tsis haum, suav nrog anaphylaxis, angioedema, xoo pob thiab urticaria. Nws tsis tuaj yeem ntseeg siab tau kwv yees ntau zaus ntawm kev txhim kho ntawm cov xwm txheej no, txij li cov lus tau txais cov xwm txheej los ntawm cov pejxeem ntawm qhov tsis paub (saib ntu "Contraindications" thiab "Cov lus qhia tshwj xeeb rau kev noj Combogliz Prolong»).

Tus naj npawb tsis muaj ntawm lymphocytes

Saxagliptin

Thaum siv saxagliptin, ib koob tshuaj tiv thaiv qhov nruab nrab txo qis hauv tus naj npawb ntawm lymphocytes tau pom. Thaum txheeb xyuas cov ntaub ntawv sib xyaw ua ke ntawm tsib 24-lub lis piam, cov kev tshawb fawb tshuaj placebo, qhov nruab nrab txo ntawm kwv yees li 100 thiab 120 hlwb / ofl ntawm tus naj npawb ntawm lymphocytes los ntawm thawj tus lej nruab nrab ntawm 2200 hlwb / wasl tau pom nrog kev siv saxagliptin ntawm koob tshuaj 5 mg thiab 10 mg, feem, piv rau nrog cov placebo. Cov txiaj ntsig zoo sib xws tau pom thaum noj saxagliptin ntawm koob tshuaj 5 mg hauv kev pib ua ke nrog metformin piv nrog metformin monotherapy. Tsis muaj qhov sib txawv ntawm 2.5 mg saxagliptin thiab placebo. Qhov kev faib ua feem ntawm cov neeg mob uas tus naj npawb ntawm lymphocytes yog ≤ 750 hlwb / wasl yog 0.5%, 1.5%, 1.4%, thiab 0.4% hauv saxagliptin kho pawg mob ntawm koob tshuaj 2.5 mg, ntawm koob tshuaj 5 mg , ntawm ib koob ntawm 10 mg thiab placebo, ntsig txog. Hauv cov neeg mob feem ntau uas rov qab siv saxagliptin, tsis muaj qhov rov huam mob tau pom, txawm hais tias nyob hauv qee tus neeg mob cov lymphocytes poob qis dua nrog kev rov pib ntawm kev kho nrog saxagliptin, uas ua rau muaj kev tshem tawm saxagliptin. Qhov txo qis hauv cov lymphocytes tsis tau nrog cov kev ua kom pom.

Cov laj thawj rau txoj kev tsawg ntawm lymphocytes thaum lub sijhawm kev kho mob saxagliptin piv nrog cov placebo tsis paub. Thaum muaj kev txawv txav lossis ua mob ntev, nws yog qhov tsim nyog yuav tau ntsuas cov lymphocytes ntau npaum li cas. Cov nyhuv ntawm saxagliptin ntawm cov lymphocytes hauv cov neeg mob uas muaj qhov txawv txav hauv cov lymphocytes (piv txwv li, cov tshuaj tiv thaiv kab mob tib neeg) tsis paub.

Saxagliptin

Saxagliptin tsis muaj qhov tshwm sim hauv kev kho mob hauv platelet ntau hauv rau ob qhov dig muag, tswj qhov kev soj ntsuam kev nyab xeeb thiab ua tau zoo.

Vitamin B Concentration₁₂

Hauv kev tswj xyuas cov kev tshawb fawb soj ntsuam cov tshuaj metformin kav ntev li 29 lub lis piam, kwv yees li 7% ntawm cov neeg mob tau txo qis cov ntshav qis dua li cov vitamin B ntau₁₂ rau cov nqi tsis tsim nyog yam tsis muaj chaw kuaj mob. Txawm li cas los xij, ib qho kev txo qis no tsis tshua muaj nrog kev loj hlob ntawm lub cev tsis muaj zog thiab rov qab sai sai tom qab tsis siv tshuaj metformin lossis ntxiv cov vitamin B kom tsawg.₁₂.

Cev xeeb tub thiab lactation

Vim tias qhov tseeb hais tias kev siv tshuaj yeeb tshuaj Combogliz Prolong thaum cev xeeb tub tsis tau kawm, cov tshuaj yuav tsum tsis txhob siv tshuaj thaum cev xeeb tub.

Kuj tsis paub meej tias saxagliptin lossis metformin kis mus rau leej niam cov kua mis tau li cas.Txij li thaum ua tau ntawm kev nkag mus ntawm cov tshuaj Combogliz Prolong rau hauv niam cov kua mis tsis cais tawm, kev siv cov tshuaj thaum lub sijhawm lactation yog contraindicated.

Siv rau cov tshuaj ua kom lub siab ua haujlwm tsis zoo Siv cov tshuaj rau lub siab ua haujlwm tsis ua haujlwm yog qhov tsis pom kev. Siv rau cov tshuaj rau lub raum kev ua haujlwm tsis zoo.

Kev siv cov tshuaj nyob hauv cov menyuam yaus

Txoj kev siv ntawm cov tshuaj yog contraindicated rau hauv cov menyuam yaus hnub nyoog qis dua 18 xyoo (kev nyab xeeb thiab ua haujlwm tsis tau kawm).

Siv rau cov neeg mob laus

Txij li thaum saxagliptin thiab metformin raug qee tawm los ntawm lub raum, thiab hauv cov neeg laus cov neeg mob lub raum ua haujlwm tsawg dua, feem ntau yuav tsum siv Combogliz Prolong nrog kev ceev faj rau cov neeg laus.

Cov lus qhia tshwj xeeb rau kev noj Combogliz Prolong

Cov kab mob lactic acidosis yog ib qho mob tsis txaus, ua rau cov metabolic hnyav uas tuaj yeem tsim los ntawm kev ua kom tiav ntawm metformin thaum kho nrog Combogliz Prolong. Nrog rau kev txhim kho ntawm cov kab mob lactic acidosis vim yog siv cov tshuaj metformin, nws cov tshuaj lom neeg hauv cov ntshav ntshav ntau dua 5 μg / ml.

Hauv cov neeg mob ntshav qab zib, lactic acidosis feem ntau muaj kev mob raum tsis zoo, suav nrog vim mob raum tsis zoo thiab lub raum tsis zoo txaus, tshwj xeeb tshaj yog thaum noj ntau yam tshuaj. Hauv cov neeg mob uas lub plawv tsis ua haujlwm, tshwj xeeb hauv cov neeg mob uas tsis muaj lub hlwb tsis khov lossis lub plawv tsis ua haujlwm thiab muaj kev pheej hmoo ntawm hypoperfusion thiab hypoxemia, muaj qhov pheej hmoo ntawm lactic acidosis. Txoj kev pheej hmoo ntawm kev txhim kho cov kab mob lactic acid nce rau hauv kev faib ua feem ntawm lub raum tsis ua haujlwm thiab tus neeg mob lub hnub nyoog. Kev tshuaj xyuas raum tsis tu ncua ntawm cov neeg mob uas siv cov tshuaj metformin yuav tsum tau ua thiab qhov kev txhaj tshuaj metformin tsawg kawg yuav tsum tau ua. Hauv cov neeg laus cov neeg mob, kev tshuaj xyuas lub raum kev ua haujlwm yog qhov tsim nyog. Metformin yuav tsum tsis txhob raug rau cov neeg mob hnub nyoog 80 xyoo thiab laus dua yog tias lub raum ua haujlwm tsis zoo (raws li QC cov ntaub ntawv), vim tias cov neeg mob no muaj kev tiv thaiv mob lactic acidosis ntau dua. Ntxiv rau, metformin kev kho mob yuav tsum tau txiav tawm tam sim ntawd yog tias muaj mob nrog hypoxemia, lub cev qhuav dej lossis mob sepsis. Txij li lub siab tsis ua haujlwm tuaj yeem txwv tsis muaj peev xwm ua kom tsis muaj zog ntau dua lactate, metformin yuav tsum tsis txhob raug rau cov neeg mob uas kuaj mob lossis kuaj pom tias muaj kab mob siab.

Qhov pib ntawm cov kab mob lactic acidosis feem ntau tsis muaj qhov cim tseg thiab muaj cov tsos mob tsis xws luag, xws li malaise, myalgia, ua pa tsis ua haujlwm, nce tsaug zog, mob thiab mob plab. Kev txo qis, hypotension, thiab tiv thaiv bradyarrhythmia kuj yuav tshwm sim. Tus neeg mob yuav tsum ceeb toom tag nrho cov tsos mob no rau tus kws kho mob. Yog tias pom cov tsos mob no, kev kho mob metformin yuav tsum tsis ua ntxiv, saib xyuas cov ntshav hluav taws xob, ketone lub cev, ntshav qabzib, thiab yog tias qhia, ntshav pH, lactate concentration thiab metformin concentration hauv cov ntshav. Kev mob plab hnyuv mob tshwm sim thaum pib kawg ntawm kev siv tshuaj metformin tuaj yeem tshwm sim los ntawm kab mob lactic acidosis lossis lwm yam kab mob.

Kev yoo mov cov leeg ntshav muaj ntshav lactate ntau tshaj li ib txwm muaj tab sis qis dua 5 mmol / L hauv cov neeg mob noj metformin yuav qhia kev txhim kho ntawm cov kab mob lactic acidosis, thiab kuj yuav yog vim lwm qhov ua rau, xws li ntshav qab zib tsis ntshav qab zib, rog rog, ntau dhau ntawm lub cev thauj khoom.

Yuav tsum kuaj xyuas txhua tus neeg mob ntshav qab zib mellitus thiab cov kab mob metabolic acidosis yam tsis muaj ketoacidosis (ketonuria thiab ketonemia). Lactic acidosis xav tau kev kho mob hauv tsev kho mob teeb tsa. Yog tias lactic acidosis raug kuaj pom hauv tus neeg mob noj cov tshuaj metformin, koj yuav tsum tsis txhob noj tshuaj tam sim ntawd thiab pib ntsuas cov kev txhawb nqa dav dav.Nws raug nquahu tias kev lim ntshav yuav tsum tau pib tam sim kom kho acidosis thiab ua rau muaj cov metformin ntau ntxiv.

Raws li koj paub, cawv potentiates cov nyhuv ntawm metformin rau cov lactate metabolism, uas ua rau muaj kev pheej hmoo ntawm cov kab mob lactic acidosis. Txwv kev haus cawv thaum noj Combogliz Prolong.

Combogliz Prolong tsis pom zoo rau cov neeg mob uas kuaj thiab kuaj pom ntawm daim siab mob vim muaj kev pheej hmoo ntawm mob lactic acidosis.

Kev ntsuam xyuas lub raum kev ua haujlwm

Ua ntej pib txoj kev kho mob nrog Combogliz Prolong thiab tsawg kawg ib xyoos ib zaug tom qab ntawd, nws yog qhov yuav tsum tau kuaj xyuas lub raum kev ua haujlwm. Hauv cov neeg mob uas xav tias lub raum tsis zoo lub raum, lub raum kev ua haujlwm yuav tsum raug ntsuas ntau dua thiab kev kho nrog Combogliz Prolong yuav tsum tsis ua ntxiv yog tias pom tias lub raum tsis ua haujlwm tshwm sim.

Koj yuav tsum tau tsum ib ntus kev siv cov tshuaj Combogliz Prolong ua ntej txhua yam kev phais mob (tshwj tsis yog cov txheej txheem me me uas tsis cuam tshuam nrog kev txwv kev noj haus thiab cov dej ua kua), thiab tsis rov pib siv nws kom txog thaum tus neeg mob tuaj yeem noj tshuaj nyob hauv thiab lub raum kev ua haujlwm tau lees paub. Cov.

Hloov pauv mus rau lub chaw kho mob tus neeg mob cov mob ntshav qab zib hom 2 tam sim no

Hauv tus neeg mob nrog T2DM, uas yav dhau los tswj tau zoo thaum kho nrog Combogliz Prolong, thiab leej twg muaj qhov hloov pauv hauv chav kuaj lossis txhim kho tus kab mob (tshwj xeeb tshaj yog muaj kev kuaj mob tsis meej), cov cim ketoacidosis lossis lactic acidosis yuav tsum tau ntsuas tam sim ntawd. Qhov kev ntsuas yuav tsum muaj kev txiav txim siab ntawm cov roj ntsha hauv cov ntshav, ketones, ntshav qabzib thiab, yog tias qhia, ntshav pH, ntau ntawm lactate, pyruvate thiab metformin. Yog tias ib daim ntawv twg ntawm acidosis tau tsim, Combogliz Prolong yuav tsum tau muab tshem tawm tam sim ntawd thiab lwm qhov kev tiv thaiv hypoglycemic tshuaj.

Kev siv cov tshuaj uas tuaj yeem ua rau txo cov ntshav qab zib

Cov tshuaj uas txhawb cov tshuaj insulin secretion, xws li sulfonylureas, tuaj yeem ua rau mob ntshav qab zib tsawg. Yog li, txhawm rau kom txo cov ntshav qog ntshav qab zib thaum ua ke nrog saxagliptin, nws yuav raug txo cov tshuaj ntawm cov tshuaj uas ua kom insulin secretion.

Kev mob ntshav qab zib tsis tsim nyob rau hauv cov neeg mob noj cov tshuaj metformin nyob rau hauv txoj kev ib txwm, tab sis tuaj yeem txhim kho nrog cov khoom noj tsis txaus carbohydrate, thaum lub cev ua si tsis yog txhawb los ntawm kev noj zaub mov carbohydrate, lossis nrog concomitant siv nrog lwm cov tshuaj hypoglycemic (xws li sulfonylureas thiab insulin derivatives) lossis cawv. Cov neeg laus, debilitated lossis tsis zoo pub cov neeg mob thiab cov neeg mob adrenal lossis pituitary tsis txaus lossis haus dej cawv ntau yog qhov cuam tshuam rau hypoglycemic teebmeem. Hauv cov neeg laus thiab cov neeg mob noj cov beta-blockers, kev kuaj mob ntawm cov qog ntshav qab zib tuaj yeem nyuaj.

Mob hnyav pab cuam rau kev ua haujlwm raum lossis faib cov tshuaj metformin

Cov tshuaj tsis haum xeeb (xws li cov tshuaj cationic, raug tso tawm los ntawm kev zais cia rau hauv lub raum plab), uas tuaj yeem cuam tshuam kev ua haujlwm ntawm lub raum, ua rau muaj qhov hloov pauv hemodynamic lossis cuam tshuam kev faib cov tshuaj metformin (saib ntu "Kev cuam tshuam nrog lwm cov tshuaj"), yuav tsum siv nrog kev ceev faj.

Kev tshawb nrhiav radiological nrog kev tswj hwm intravascular ntawm iodinated sib piv cov neeg sawv cev

Thaum ua kev tshawb nrhiav radiological nrog kev tswj hwm intravascular ntawm iodine-muaj cov tshuaj tiv thaiv kab mob, kev mob raum tsis ua haujlwm tau raug txheeb xyuas, uas tuaj yeem nrog kev txhim kho ntawm cov kab mob lactic acidosis hauv cov neeg mob uas tau txais metformin. Cov neeg mob uas tau teem sijhawm rau kev kawm no yuav tsum tshem tawm txoj kev kho Combogliz Prolong tsis pub dhau 48 teev ua ntej ua cov txheej txheem no, tsis kam noj cov tshuaj nyob rau hauv 48 teev tom qab tau ua tiav, thiab rov pib kho mob tsuas yog tom qab lub raum kev ua haujlwm tau paub tseeb.

Kev mob plawv (poob siab) ntawm ib qho keeb kwm, mob plawv tsis ua haujlwm, mob myocardial infarction thiab lwm yam mob nrog hypoxia thiab lactic acidosis tuaj yeem ua rau prerenal azotemia. Nrog rau kev txhim kho ntawm cov xwm txheej zoo li no, nws yog ib qho tsim nyog yuav tsum tau tso tseg txoj kev kho tam sim ntawd nrog Combogliz Prolong.

Tsis hnov qab cov ntshav zoo

Kub taub hau, mob, mob, phais yuav ua rau txhaum ntawm cov concentration ntawm cov piam thaj hauv cov ntshav, uas tau ua dhau los tswj hwm nrog kev pab los ntawm cov tshuaj Combogliz Prolong. Hauv cov xwm txheej no, yuav tsum tau tshem tawm kev kho mob ib ntus thiab hloov tus neeg mob mus rau kev kho mob insulin tej zaum yuav tsum tau ua. Tom qab ua kom lub zog nyob hauv kev ua kom cov ntshav qab zib nyob rau hauv cov ntshav thiab txhim kho kev mob ntawm tus neeg mob, kev kho nrog Combogliz Prolong tuaj yeem rov ua dua.

Thaum lub sijhawm tomqab lawb lag luam siv saxagliptin, muaj qhov tsis haum lub cev tsis haum lub ntsej muag, suav nrog anaphylaxis thiab angioedema. Nrog rau kev txhim kho qhov kev hloov pauv tsis haum, kev siv tshuaj yuav tsum tau txiav tawm, lwm yam kev ua rau kev tshwm sim yuav tsum raug ntsuas, thiab lwm txoj kev kho mob ntshav qab zib mellitus yuav tsum tau kho (saib "Contraindications" thiab "Sab sij huam»).

Cuam tshuam rau kev muaj peev xwm tsav tsheb thiab tswj cov tshuab

Kev tshawb nrhiav ntawm cov txiaj ntsig ntawm saxagliptin ntawm kev muaj peev xwm tsav tsheb thiab kev tswj cov tshuab tseem tsis tau ua.

Nco ntsoov tias saxagliptin tuaj yeem ua rau mob taub hau.

Noj ntau dhau

Nrog lub sijhawm ntev ntawm kev siv cov tshuaj hauv cov koob tshuaj kom txog 80 zaug siab dua qhov kev pom zoo, cov tsos mob ntawm intoxication tsis tau piav qhia.

Nyob rau hauv rooj plaub ntawm overdose, kev kho mob tsos mob yuav tsum tau siv. Saxagliptin thiab nws cov metabolite tseem ceeb yog txaws los ntawm hemodialysis (kev tsis txaus siab: 23% ntawm qhov hno hauv 4 teev).

Muaj qee tus neeg mob haus ntshav ntau tshaj ntawm cov tshuaj metformin, suav nrog kev noj ntau dua 50 g. Hauv 32% ntawm cov neeg haus tshuaj ntau tshaj ntawm metformin, cov neeg mob tau mob lactic acidosis. Metformin raug tawm hauv kev lim ntshav, thaum lub sijhawm meej txog 170 ml / min.

Kev sib cuam tshuam nrog Lwm Yam Tshuaj

Qee cov tshuaj nce hyperglycemia (thiazide thiab lwm yam diuretics, glucocorticosteroids, phenothiazines, kev npaj ntawm iodine-muaj cov thyroid hormones, estrogens, qhov ncauj tawm tsam, phenytoin, nicotinic acid, sympathomimetics, qeeb calcium channel blockers thiab isoniazid). Thaum sau ntawv lossis tso tseg cov tshuaj no rau hauv tus neeg mob noj Combogliz Prolong, ua tib zoo saib xyuas qhov kev nyeem ntawm cov piam thaj hauv cov ntshav. Qhov sib khi ntawm metformin rau cov ntshav plasma proteins muaj tsawg, yog li nws tsis pom zoo tias nws yuav cuam tshuam nrog cov tshuaj uas cuam tshuam rau cov ntshav plasma protein ntau, xws li salicylates, sulfonamides, chloramphenicol thiab probenecid (hauv kev sib piv ntawm sulfonylurea derivatives, uas muaj ntau yam tseem ceeb) nrog cov ntshiab protein).

Qhov ntsuas ntawm isoenzymes CYP3A4 / 5

Rifampicin cuam tshuam txo qis kev cuam tshuam ntawm saxagliptin yam tsis hloov AUC ntawm nws cov nquag metabolite, 5-hydroxy-saxagliptin. Rifampicin tsis cuam tshuam rau qhov kev txwv tsis pub DPP-4 nyob rau hauv cov ntshav ntshav thaum lub sijhawm 24-teev kev kho mob.

CYP3A4 / 5 Isoenzyme Tus Neeg Txom Nyem

Diltiazem txhim kho kev muaj txiaj ntsig ntawm saxagliptin thaum siv ua ke.Kev nce siab ntawm saxagliptin nyob rau hauv cov ntshav ntshav yog yuav tsum siv amprenavir, aprepitant, erythromycin, fluconazole, fosamprenavir, kua txiv kab ntxwv qaub thiab verapamil, txawm li cas los xij, koob tshuaj saxagliptin tsis pom zoo. Ketoconazole ua rau ntau cov kev xav ntawm saxagliptin hauv ntshav. Ib qho zoo sib xws tseem ceeb ntxiv rau qhov kev txiav txim ntawm saxagliptin hauv cov ntshav ntshav yog xav tau thaum lwm qhov muaj zog inhibitors ntawm nzoenzymes CYP3A4 / 5 tau siv (piv txwv, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir). Thaum muab sib xyaw nrog ib qho muaj zog inhibitor ntawm CYP3A4 / 5 isoenzymes, qhov koob tshuaj saxagliptin yuav tsum txo kom tsawg li 2.5 mg.

Cov tshuaj Cationic (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterone, trimethoprim lossis vancomycin), uas yog tawm los ntawm lub raum los ntawm kev lim ntshav, txhawm rau qhov kev sib txuas lus nrog metformin, kev sib tw rau cov kev thauj mus los ntawm cov leeg. Hauv kev tshawb fawb txog kev sib cuam tshuam yeeb tshuaj ntawm metformin thiab cimetidine nrog ib zaug thiab rov ua dua ntawm cov tshuaj, kev sib cuam tshuam ntawm metformin thiab cimetidine rau kev tswj hwm qhov ncauj hauv kev noj qab haus huv tau pom, nrog 60% nce ntxiv ntawm qhov siab tshaj plaws ntawm metformin hauv plasma thiab tag nrho cov ntshav thiab nce 40% hauv AUC ntawm metformin hauv plasma thiab tag nrho ntshav. Thaum lub sij hawm kawm nrog ib zaug tshuaj ntawm cov tshuaj, tsis muaj kev hloov pauv hauv ib nrab-lub neej. Metformin tsis cuam tshuam rau pharmacokinetics ntawm cimetidine. Nws raug nquahu kom ua tib zoo saib xyuas cov neeg mob thiab, yog tias tsim nyog, kho cov koob tshuaj rau cov neeg mob noj tshuaj cationic uas raug tso tawm los ntawm qhov siab nyob ze lub plab hlaub.

Hauv kev kawm txog kev sib cuam tshuam nrog kev txhaj tshuaj ib zaug hauv cov neeg mob ntshav qab zib hom 2, kev sib xyaw ntawm kev siv tshuaj metformin thiab glibenclamide tsis cuam tshuam rau pharmacokinetics lossis pharmacodynamics.

Hauv kev kawm txog kev sib cuam tshuam yeeb tshuaj ntawm metformin thiab furosemide nrog ib zaug ntawm cov tshuaj, ua rau cov neeg ua haujlwm noj qab haus huv, lawv cov kev sib raug zoo pharmacokinetic tau qhia. Furosemide nce C_max metformin hauv plasma thiab ntshav los ntawm 22% thiab AUC hauv cov ntshav los ntawm 15% yam tsis muaj kev hloov pauv tseem ceeb hauv kev kho lub raum ntawm metformin. Thaum noj nrog metformin C_max thiab AUC ntawm furosemide yog txo los ntawm 31% thiab 12%, ntsig txog, thiab ib nrab lub neej raug txo qis los ntawm 32% yam tsis muaj qhov pom kev hloov hauv kev rov ua haujlwm ntawm furosemide. Tsis muaj cov ntaub ntawv hais txog kev cuam tshuam ntawm metformin thiab furosemide nrog ua ke siv ntev.

Hauv kev kawm txog kev sib cuam tshuam yeeb tshuaj ntawm metformin thiab nifedipine nrog ib zaug tshuaj ntawm cov tshuaj, ua rau cov neeg tuaj yeem noj qab haus huv, nifedipine nce C_max metformin hauv plasma los ntawm 20% thiab AUC los ntawm 9%, thiab nce ntxiv los ntawm lub raum. T_max thiab T_1/2 tsis hloov. Nifedipine tsub kom ntau ntxiv kev nqus ntawm metformin. Metformin tsis muaj kev cuam tshuam zoo li ntawm cov tshuaj pharmacokinetics ntawm nifedipine.

Saxagliptin thiab Metformin

Kev sib xyaw ntawm kev siv ib zaug ntawm saxagliptin (100 mg) thiab metformin (1000 mg) tsis muaj kev cuam tshuam ntau yam ntawm cov tshuaj pharmacokinetics ntawm saxagliptin lossis metformin hauv cov neeg ua haujlwm noj qab haus huv.

Tsis muaj kev kawm tshwj xeeb pharmacokinetic txog kev sib txuam nrog tshuaj nrog kev siv Combogliz Prolong tau ua, txawm hais tias cov kev tshawb fawb no tau ua nrog nws cov khoom siv: saxagliptin thiab metformin.

Cov nyhuv ntawm lwm cov tshuaj ntawm saxagliptin

Glibenclamide: Kev sib xyaw ua ke siv ib qho saxagliptin (10 mg) thiab glibenclamide (5 mg), ib qho keeb ntawm isoenzyme CYP2C9, nce C_max saxagliptin los ntawm 8%, txawm li cas los xij, saucagliptin AUC tsis hloov.

Pioglitazone: Cov kev sib xyaw ua ke rov qab siv saxagliptin ib zaug ib hnub (10 mg) thiab pioglitazone (45 mg), ib qho keeb ntawm isoenzyme CYP2C8 (muaj zog) thiab CYP3A4 (qaug zog), tsis cuam tshuam rau pharmacokinetics ntawm saxagliptin.

Digoxin: Kev sib xyaw ua ke rov qab siv saxagliptin ib zaug ib hnub (10 mg) thiab digoxin (0.25 mg), ib qho tshuaj P-glycoprotein, tsis cuam tshuam rau lub pharmacokinetics ntawm saxagliptin.

Simvastatin: Cov kev sib xyaw ua ke rov qab siv saxagliptin ib zaug ib hnub (10 mg) thiab simvastatin (40 mg), ib qho keeb ntawm CYP3A4 / 5 isoenzymes, nce C_max saxagliptin los ntawm 21%, tab sis saxagliptin AUC tsis hloov.

Diltiazem: Kev sib xyaw ua ke ntawm kev siv saxagliptin (10 mg) thiab diltiazem (360 mg ntev npaum li cas daim ntawv tshuaj nyob rau hauv kev sib npaug), cov tshuaj tsis haum ntawm CYP3A4 / 5 isoenzymes, nce C_max saxagliptin los ntawm 63%, thiab AUC - 2.1 npaug. Qhov no yog nrog nrog qhov txo qis hauv C_max thiab AUC ntawm cov nquag metabolite los ntawm 44% thiab 36%, feem.

Ketoconazole: Kev siv sib xyaw nrog ib koob tshuaj saxagliptin (100 mg) thiab ketoconazole (200 mg txhua 12 teev hauv qhov sib luag), nce_max thiab AUC ntawm saxagliptin 2.4 thiab 3.7 npaug, muaj. Qhov no yog nrog nrog qhov txo qis hauv C_max thiab AUC ntawm cov nquag metabolite los ntawm 96% thiab 90%, feem.

Rifampicin: Kev siv sib xyaw ua ke ntawm ib qho txhaj tshuaj saxagliptin (5 mg) thiab rifampicin (600 mg ib hnub ib zaug hauv qhov sib npaug)_max thiab AUC ntawm saxagliptin los ntawm 53% thiab 76%, xwm yeem, nrog kev sib txuam hauv C_max(39%), tab sis tsis muaj kev hloov pauv tseem ceeb hauv AUC ntawm cov tshuaj metabolite.

Omeprazole: Kev siv ntau yam tshuaj saxagliptin ntawm koob tshuaj 10 mg ib hnub ib zaug thiab omeprazole ntawm koob tshuaj 40 mg, ib qho tshuaj tiv thaiv isoenzyme CYP2C19 (muaj zog) thiab isoenzyme CYP3A4 (qaug zog), ib qho inhibitor ntawm isoenzyme CYP2C19 thiab cov tshuaj tiv thaiv MRP-3, tsis cuam tshuam.

Aluminium hydroxide + magnesium hydroxide + simethicone: Kev siv sib xyaw ua ke ntawm ib koob tshuaj saxagliptin (10 mg) thiab kev ncua uas muaj txhuas hydroxide (2400 mg), magnesium hydroxide (2400 mg) thiab simethicone (240 mg) qis C_max saxagliptin los ntawm 26%, txawm li cas los saxagliptin AUC tsis hloov.

Famotidine: Noj ib koob tshuaj saxagliptin (10 mg) 3 teev tom qab siv ib zaug koob tshuaj famotidine (40 mg), ib qho inhibitor ntawm hOCT-1, hOCT-2, thiab hOCT-3, nce C_max saxagliptin los ntawm 14%, txawm li cas los xij, saucagliptin AUC tsis hloov.

Cov Cai Siv Tshuaj So

Cov tshuaj yog ntawv yuav tshuaj.

Cov lus thiab cov xwm txheej ntawm kev cia

Nyob rau qhov kub thiab txias tsis tshaj 30 ° C. Khaws tsis ncav cuag ntawm cov menyuam yaus. Txee lub neej yog 3 xyoos.

Kev siv tshuaj yeeb yaj kiab Combogliz lub caij nyoog tsuas yog tsim los ntawm kws kho mob, kev qhia yog muab rau siv!

Tso tawm daim ntawv, muaj pes tsawg leeg thiab ntim khoom

Muaj nyob rau hauv peb version ntawm cov ntsiab lus ntawm cov khoom siv sib xyaw (mg):

metformin - 1000, saxagliptin - 2.5,
metformin - 1000, saxagliptin - 5.0,
metformin - 500, saxagliptin - 5.0.

Ntxiv nrog rau:

magnesium stearate,
carmellose sodium
hypromellose.

Muaj 7 ntsiav tshuaj nyob hauv ib lub hlwv, hauv ib pob ntawv cardboard nrog thawj qhov qhib tswj tau tuaj yeem muaj 4 los yog 8 hlwv.

Pharmacological kev txiav txim

Cov ntsiav tshuaj ua ke nrog kev ua ub ua no, hloov kho tawm thiab cov ntsiab lus ntawm ob qho kev ua ub ua no uas sib txuam.

Metformin yog qhov loj. Nws inhibits gluconeogenesis, cuam tshuam nrog kev tiv thaiv oxidation ntawm cov rog thiab ua rau cov rhiab heev ntawm receptors rau insulin. Kev siv cov kua nplaum ntawm tes ua haujlwm tau. Qhov feem cuam tsis cuam tshuam rau cov ntsiab lus ntawm insulin hauv ntshav los ntawm nws tus kheej, tsis ua rau hypoglycemia. Nws kuj ua rau kev sib sau glycogen. Muaj piam thaj ntau rau kev hloov pauv vim raug rau cov qe. Tsis tas li ntawd, cov tshuaj muaj peev xwm txo qis kev nqus ntawm kev nqus ntawm cov piam thaj hauv lub plab zom mov, vim tias nws ua rau muaj qhov ua kom yuag. Yuav txhim kho qee lub zog ntawm cov ntshav.

Saxagliptin tsub kom tso cov tshuaj hormones tshwj xeeb - nce ntxiv. Lawv txhawb tawm qhov kev tso tawm ntawm cov kua dej los ntawm beta hlwb ntawm cov txiav thiab txo qis kev tsim cov glucagon hauv nws. Lub peev xwm tseem ceeb ntawm saxagliptin yog kom txo cov piam thaj hauv qab ntawm lub plab thiab nrog zaub mov.Ntxiv rau, qhov tso tawm ntawm lub plab yog inhibited, kom lub ntsej muag ntev dua tau txais. Nws kuj tseem pab txhawb nqa rau qhov poob phaus hauv cov neeg mob ntshav qab zib.

Vim yog hloov kho tau tso tawm, qhov pheej hmoo ntawm phiv los ntawm txoj hnyuv txhawm rau txo qis.

Cov Yuav Tsum Muaj

Hypersensitivity rau Cheebtsam,
Keeb kwm kev poob siab anaphylactic,
Yam 1 ntshav qab zib
Lactose tsis txaus ntseeg,
Kev kho mob insulin
Tshawb nrhiav siv tshuaj yeeb dej iodine (48 teev ua ntej thiab tom qab),
Plab tsis zoo lub raum thiab hepatic muaj nuj nqi,
Mob hnyav, mob ntsws thiab kis mob,
Ntshav qab zib ketoacidosis
Keeb kwm ntawm coma
Txoj kev pheej hmoo ntawm cov ntaub so ntswg hypoxia,
Keeb kwm ntawm cov kab mob lactic acidosis,
Kev noj zaub mov kom tsawg
Cev xeeb tub thiab lactation
Tsis txog 18 xyoo
Kev quav cawv

Cov lus qhia rau siv (qauv thiab ntau npaum li cas)

Nws raug xaiv ntawm tus kheej raws cov lus tim khawv.

Siv 1 zaug nyob rau ib hnub thaum tib lub sijhawm. Lub plhaub yuav tsum tsis txhob tawg, vim tias qhov no cuam tshuam rau tus nqi tso tawm. Haus dej kom ntau.

Kev kho mob pib nrog 500 + 2.5 mg ntsiav tshuaj, tom qab ntawd tuaj yeem nce ntxiv rau 1000 + 5 mg. Qhov Ntau Ntau - 2000 + 5 mg. Ua kom ntau ntxiv cov tshuaj zuj zus kom txo cov teebmeem tsis muaj teebmeem.

Yog tias ua ntej tus neeg mob no tau txais kev kho mob nrog cov neeg sawv cev uas muaj cov tshuaj no, tab sis nyias cais nyias, kev xaiv koob tshuaj yog xaiv raws li yav dhau los. Cov nyhuv ntawm lub cev ntawm kev hloov pauv los ntawm lwm cov tshuaj hypoglycemic rau cov tshuaj no tseem tsis tau kawm.

Sab sij huam

Mob taub hau, yastes yastaw,
Kev kis mob rau cov leeg
Mob plab
Kev mob pob txha
Xeev siab thiab ntuav
Zawv plab
O o
Kev mob ntshav siab (los ntawm saxagliptin),
Urticaria,
Thrombocytopenia
Kev ua xua tsis haum
Nasopharyngitis,
Mob plab zom mov
Kev mob caj dab
Saj tsis xis nyob
Flatulence.

Lawv raug tshem tawm txawm tias hloov qhov ntau npaum li cas, lossis ncua tseg cov tshuaj.

Noj ntau dhau

Yog tias qhov kev txwv tsis pub tshaj, lactic acidosis yuav tshwm sim. Qhov no yog fraught nrog loj txim - txawm tias tuag. Yog tias muaj kev ua xyem xyav ntawm nws txoj kev loj hlob, tus neeg mob yuav tsum tau mus pw hauv tsev kho mob. Lub tsev kho mob muab tshuaj rau qhov kho cov mob hemodialysis thiab kev kho tus yam ntxwv.

myalgia
ua pa tsis ua hauj lwm
nce toj zog nkees
mob plab
hnov tsw ntawm acetone los ntawm lub qhov ncauj.

Thaum noj lwm yam tshuaj, tshwj xeeb tshaj yog raws li sulfonylurea, qhov kev pheej hmoo ntawm hypoglycemia nce. Nws cov tsos mob: tsis muaj zog, pallor ntawm daim tawv nqaij, lub cev tsis hnov qab (nce mus txog thaum tsis nco qab), kev tshaib plab, kev txob taus, thiab lwm tus. Daim ntawv yooj yim tshem tawm qhov kev nkag ntawm cov khoom noj qab zib. Ntshav thiab mob hnyav - txhaj tshuaj glucagon lossis dextrose kev daws teeb meem. Nws yog ib qho tseem ceeb uas yuav coj ib tus neeg kom nco qab, thiab tom qab ntawd sab laj tus kws kho mob rau kev hloov pauv ntawm cov tshuaj.

Yeeb tshuaj sib cuam tshuam

Txhim khu qhov kev nqis tes ntawm cov kev ua haujlwm:

txhuas hydroxide,
pioglitazone
magnesium hydroxide,
rifampicin
GKS,
nicotinic acid
simethicone
estrogens
thiazide diuretics,
cov thyroid hormones,
isoniazid
phenothiazines,
phenytoin
sympathomimetics
blockers ntawm cov calcium calcium qeeb.

Txo qhov ua tau zoo ntawm cov tshuaj nquag:

diltiazem
fluconazole
amprenavir
verapamil
erythromycin,
ketoconazole
aprepitant
glibenclamide,
sulfonylurea derivatives,
txiv kab ntxwv qaub
kev tshaib plab
isoenzymes CYP3A4 / 5,
furosemide
cationic npaj
nifedipine
ethanol.

Tus kws kho mob uas koom nrog yuav tsum paub txog kev kho mob nrog cov tshuaj no thaum sau ntawv kho.

Cov lus qhia tshwj xeeb

Txij li cov tshuaj tawm hauv lub raum, nws raug nquahu kom ua ntu zus los ntsuas thiab saib xyuas lawv tus mob kom tiv thaiv tau cov kev mob ntxiv. Qhov no muaj tseeb tshwj xeeb ntawm cov neeg laus.

Hauv cov neeg mob tom qab 60 xyoo, lactic acidosis tshwm sim ntau zaus. Yuav tsum muaj kev saib xyuas tas li los ntawm tus kws tshaj lij.

Muaj peev xwm ntawm kev txhim kho pancreatitis nce. Cov tsos mob tseem ceeb yog mob hnyav, mob ntev hauv plab.

Tus neeg mob yuav tsum paub cov tsos mob tshwm sim thiab tuaj yeem muab kev pabcuam ua ntej.

Yog tias tsim nyog, tib neeg kev phais mob tau muab xa mus rau insulin.

Tsis muaj kev tshawb fawb tau tshawb pom tias muaj txiaj ntsig ntawm kev muaj peev xwm tsav tsheb. Txawm li cas los xij, nrog kev kho mob ua ke, txoj kev pheej hmoo ntawm hypoglycemia yuav tsum nco ntsoov. Saxagliptin tuaj yeem ua rau mob taub hau thiab mob tob hau. Qhov kev txiav txim siab hais txog kev muaj peev xwm tsav tsheb los yog ua haujlwm nrog cov txheej txheem yog ua los ntawm tus kws tshwj xeeb.

Piv nrog analogues

Cov tshuaj no muaj tus lej ntawm cov se rau qhov muaj pes tsawg leeg thiab muaj zog. Nws yuav zoo siv los paub koj tus kheej zoo nrog lawv.

"Yanumet." Nqe - los ntawm 2830 rubles rau 56 ntsiav tshuaj. Qhov muaj pes tsawg leeg suav nrog metformin thiab sitagliptin. Cov chaw tsim khoom hauv lub tuam txhab Merck Sharp thiab Dome, USA. Nws tuaj yeem siv rau hauv kev txuam nrog cov tshuaj insulin, txawm li cas los xij, ntau yam tshwm sim thiab contraindications. Tsis txhob ua daim ntawv yuav rau menyuam yaus thiab pojniam xeeb tub. Coob tus sau tias cov tshuaj sai txo qhov hnyav.

Galvus Met. Tus nqi - 1500 rubles thiab sab saud. Muaj cov tshuaj metformin thiab vildagliptin. Cov neeg tsim khoom - "Novartis", Switzerland. Nws yog qhov pheej yig dua, txawm hais tias nws lub zog tsis txawv ntawm “Comboglize”. Daim ntawv teev cov contraindications zoo ib yam.

"Comboglize Xr." Nws muaj cov zoo sib xws. Tshaj tawm los ntawm lub tuam txhab AstraZeneca, Great Britain. Ntsiav tshuaj yuav raug nqi 1650 rubles rau ib pob. Qhov ze tshaj plaws hauv cov khoom hauv cov khoom. Tag nrho cov kev mob tshwm sim thiab contraindications yog tib yam.

Glibomet. Cov tshuaj tsim los ntawm lub tuam txhab "Berlin Chemie", lub teb chaws Yelemees. Nqe - 350 rubles rau ib pob. Cov khoom xyaw nquag - glibenclamide thiab metformin. Tsis haum rau txhua tus. Ntau qhov kev txwv tsis pub siv.

Bagomet. Metformin thiab glibenclamide-muaj cov ntsiav tshuaj. Nqe - los ntawm 160 rubles. Lawv muaj qhov kev txiav txim siab txuas ntxiv, yog tsim los ntawm lub tuam txhab Chemistry Montpellier, Argentina. Lub ntsiab ntxiv yog txo nqi nrog kwv yees li thaj chaw. Cov khoom sib tshuam zoo sib xws.

Txoj kev txiav txim siab hloov mus rau lwm cov tshuaj yog ua los ntawm tus kws kho mob. Kev siv tus kheej yog txwv!

Feem ntau muaj cov zoo kev xav ntawm cov tshuaj. Qhov tsis zoo tsuas yog tus nqi ntau. Tsis tas li hauv kev txheeb xyuas nws tau sau tseg tias cov neeg uas tau coj ua ntej cov tshuaj metformin no piv nrog lub xeev yav dhau los muaj cov kev mob tshwm sim tsawg dua. Kev hnyav lub cev yuag tseem pom, tab sis tsuas yog noj zaub mov.

Victor: “Kuv siv cov tshuaj metformin-based ntau xyoo. Lawv tsum tsis txhob muab cov nyhuv uas xav tau, tus kws kho mob tau tshaj tawm txoj kev npaj ua ke "Combogliz Prolong". Qhov kuv nyiam: sai sai ua rau tshwm sim, tsuas haus ib ntsiav ib hnub. Ua kom hnyav thiab qab zib theem. Qhov kuv tsis nyiam: muaj cov kev mob tshwm sim, tshwj xeeb yog koj ua txhaum kev noj zaub mov. Nws pab zoo, txawm tias nws yuav kim heev. ”

Alexandra: “Kuv yog tus mob ntshav qab zib uas muaj kev paub ntau. Nyob rau hauv xyoo tas los, Kuv tsuas yog siv cov tshuaj uas siv tshuaj. Tam sim no kuv txais Combogliz Prolong. Cov tshuaj zoo, Kuv tsis muaj kev phiv. Nws yooj yim rau kev txais tos, tus nqi / kev ua tau zoo piv rau kuv kiag li. "

Xaus

Cov tshuaj no ua tau zoo heev. Ua tsaug rau cov nta ntawm kev tso tawm, nws pab ua kom tsis txhob muaj kev txhim kho ntawm cov teeb meem nrog txoj hnyuv plab. Kev tshuaj xyuas los ntawm cov neeg siv yeeb tshuaj thiab cov kws tshaj lij feem ntau yog qhov zoo. Qhov tsis zoo tsuas yog tus nqi siab thiab qhov yuav tsum tau xaj nyob hauv lub tsev muag tshuaj. Txwv tsis pub, nws yog cov tshuaj zoo rau ntshav qab zib.

Txoj kev ntawm daim ntawv thov

Rau cov neeg laus: Kuv noj qhov ncauj 1 teev / hnub thaum noj hmo. Cov tshuaj yuav tsum tau xaiv ib tus zuj zus.
Feem ntau, nrog cov tshuaj sib xyaw ua ke muaj saxagliptin thiab metformin, koob tshuaj saxagliptin yog 5 mg 1 zaug / hnub. Qhov pom zoo kom pib koob tshuaj metformin hloov kho tso tawm yog 500 mg 1 zaug / hnub, nws tuaj yeem nce txog 2000 mg 1 zaug / hnub.
Qhov koob tshuaj ntawm metformin tau nce ntau zuj zus mus txo qhov kev pheej hmoo ntawm kev phiv los ntawm cov hnyuv hauv plab.
Qhov siab ntau tshaj tawm txhua hnub: saxagliptin 5 mg thiab hloov kho tshaj tawm metformin 2000 mg.

- Hom 2 mob ntshav qab zib mellitus ua ke nrog kev noj haus thiab qoj ib ce kom txhim kho glycemic tswj.

Daim ntawv noj tshuaj:

Ib txheej-ntim cov ntsiav tshuaj nrog kev hloov pauv tsis zoo

1000 mg + 2.5 mg muaj.

Yam tshuaj muaj zog: metformin hydrochloride 1000 mg + saxagliptin 2.5 mg

Lub ntsiab ntawm cov ntsiav tshuaj: metformin hydrochloride tov nrog 0.5% magnesium stearate 1005.0 mg (1000.0 mg metformin hydrochloride + 5.0 mg magnesium stearate), sodium carmellose 50.0 mg, hypromellose 2208 393.0 mg, magnesium stearate 2.0 mg

thawj txheej txheej plhaub txheej txheej (tiv thaiv): Opadry II dawb (% m / m) 130.5 mg polyvinyl cawv ib nrab hydrolyzed 40.00%, titanium dioxide 25.00%, macrogol 3350 20.20%, talc 14.80%, 1 M daws ntawm hydrochloric acid rau pH 2 , 0 ± 0.3 *,

thib ob txheej ntawm plhaub txheej (ua haujlwm): saxagliptin 2.5 mg, Opadray II dawb 20.0 mg, 1 M daws cov hydrochloric acid rau pH 2.0 ± 0.3 *,

zaj duab xis plhaub (txheej thib peb ntawm txheej (xim)): Opadry II daj (% m / m) 48.0 mg polyvinyl cawv ib nrab hydrolyzed 40.00%, titanium dioxide 24.25%, macrogol 3350 20.20%, talc 14.80%, zas hlau oxide daj 0.75% , 1 M daws ntawm hydrochloric acid rau pH 2.0 ± 0.3 *,

number case kev sau ntawv: mem kua Opacode xiav ** (% m / m) 0.03 mg indigo carmine txhuas cov kua roj vanish 16.00%, shellac

45% (20% esterified) hauv ethanol 55.40%, butanol 15.00%, propylene glycol 10.50%, isopropanol 3.00%, 28% daws ntawm ammonium hydroxide 0.10%.

Ib 500 mg + 5 mg zaj duab xis-coated ntsiav tshuaj muaj.

Yam tshuaj muaj zog: metformin hydrochloride 500 mg + saxagliptin 5 mg

Lub ntsiab ntawm cov ntsiav tshuaj: metformin hydrochloride nyob rau hauv kev sib xyaw nrog 0.5% magnesium stearate 502.5 mg (500.0 mg metformin hydrochloride + 2.5 mg magnesium stearate), sodium carmellose 50.0 mg, hypromellose 2208 358.0 mg, hypromellose 2910 10.0 mg, microcrystalline cellulose 102.0 mg, magnesium stearate 1.0 mg,

thawj txheej txheej plhaub txheej txheej (tiv thaiv): Opadry II dawb (% m / m) 99.0 mg polyvinyl cawv ib nrab hydrolyzed 40.00%, titanium dioxide 25.00%, macrogol 3350 20.20%, talc 14.80%, 1 M daws ntawm hydrochloric acid rau pH 2 , 0 ± 0.3 *, bi thib ob txheej ntawm txheej txheej (nquag): saxagliptin 5.0 mg, Opadry II dawb 20.0 mg, 1 M daws ntawm hydrochloric acid rau pH 2.0 ± 0.3 *,

zaj duab xis plhaub (txheej thib peb ntawm txheej (xim)): Opadry II tawny (% m / m) 33.0 mg polyvinyl cawv ib nrab hydrolyzed 40.00%, macrogol 3350 20.20%, titanium dioxide 19.58%, talc 14.80%, zas hlau oxide daj 5, 00% thiab zas xim hlau oxide liab 0.42%, 1 M daws ntawm hydrochloric acid rau pH 2.0 ± 0.3 *,

number case kev sau ntawv: mem kua Opacode xiav ** (% m / m) 0.03 mg indigo carmine txhuas cov kua roj vanish 16.00%, shellac

45% (20% esterified) hauv ethanol 55.40%, butanol 15.00%, propylene glycol 10.50%, isopropanol 3.00%, 28% daws ntawm ammonium hydroxide 0.10%.

Ib qho 1000 mg + 5 mg zaj duab xis-ntsiav tshuaj muaj:

Yam tshuaj muaj zog: hydrochloride 1000 mg + saxagliptin 5 mg Lub ntsiab ntawm cov ntsiav tshuaj: metformin hydrochloride tov nrog 0.5% magnesium stearate 1005.0 mg (1000.0 mg metformin hydrochloride + 5.0 mg magnesium stearate), sodium carmellose 50.0 mg, hypromellose 2208 393.0 mg, magnesium stearate 2.0 mg

thib ob txheej ntawm plhaub txheej (ua haujlwm): saxagliptin 5.0 mg, Opadry II dawb 20.0 mg, 1 M hydrochloric acid tov rau pH 2.0 ± 0.3 *,

zaj duab xis plhaub (txheej thib peb ntawm txheej (xim)): Opadry II paj yeeb (% m / m) 48.0 mg polyvinyl cawv ib nrab hydrolyzed 40.00%, titanium dioxide 24.25%, macrogol 3350 20.20%, talc 14.80%, zas hlau oxide liab 0.75% , 1 M daws ntawm hydrochloric acid rau ib pH ntawm 2.0 ± 0.3 *,

number case kev sau ntawv: mem kua Opacode xiav ** (% m / m) 0.03 mg indigo carmine txhuas cov kua roj vanish 16.00%, shellac

45% (20% esterified) hauv ethanol 55.40%, butanol 15.00%, propylene glycol 10.50%, isopropanol 3.00%, 28% daws ntawm ammonium hydroxide 0.10%.

* Yog tias tsim nyog, tov 1 M sodium hydroxide tov tuaj yeem siv los kho lub pH.
** Yog tias tsim nyog, isopropanol cawv ntxiv rau tus cwj mem thaum lub sijhawm ua daim ntawv lo. Cov kab ntawm indigo carmine txhuas cov kua roj vanish thiab shellac nyob twj ywm rau ntawm cov ntsiav tshuaj thaum inscription thov. Cov kuab tshuaj uas nyob hauv tus number case yuav raug tshem tawm thaum tsim tawm thaum lub sijhawm ziab.

1000 mg + 2.5 mg ntsiav tshuaj:

Cov tshuaj ntsiav npuag-biconvex zoo li lub ntsej muag, zaj duab xis-txheej los ntawm daj ntseg daj mus rau lub teeb daj xim, nrog cov lus "2.5 / 1000" ntawm ib sab thiab "4222" nyob rau sab nraud, hauv cov kua mem xiav.

500 mg + 5 mg ntsiav tshuaj:
Cov tshuaj ntsiav uas zoo li lub khob tshuaj, pleev xim ntawm xim av mus rau xim av, nrog cov lus “5/500” ntawm ib sab thiab “4221” nyob rau sab nraud, hauv cov kua mem xiav.

1000 mg + 5 mg ntsiav tshuaj:
Cov tshuaj ntsiav uas zoo li lub khob tshuaj, them nrog cov xim xaum zaj duab xis, nrog cov lus "5/1000" ntawm ib sab thiab "4223" ntawm lwm sab, hauv cov kua mem xiav.

PHARMACOLOGICAL COV CAI

Cov Tshuaj Hauv Tshuaj

Mechanism ntawm kev ua
Combogliz Prolong® muab ob qho tshuaj tiv thaiv hypoglycemic nrog sib xyaw ua ke ntawm kev nqis tes ua los txhim kho glycemic tswj hauv cov neeg mob uas muaj hom 2 mob ntshav qab zib mellitus (T2DM): saxagliptin, dipeptidyl peptidase 4 inhibitor (DPP-4), thiab metformin, tus sawv cev ntawm chav kawm biguanide.

Saxagliptin
Hauv kev teb rau kev noj zaub mov los ntawm cov hnyuv me, cov tshuaj hormones ntau ntxiv tso rau hauv cov ntshav, xws li glucagon-zoo li peptide-1 (GLP-1) thiab glucose-dependant insulinotropic polypeptide (HIP). Cov tshuaj hormones no txhawb lub cev tawm ntawm insulin los ntawm pancreatic beta hlwb, nyob ntawm qhov kev saib xyuas ntawm cov piam thaj hauv cov ntshav, tab sis tsis ua li cas los ntawm enzyme DPP-4 rau ob peb feeb. GLP-1 kuj tseem qis qis qhov zais cia ntawm glucagon hauv cov roj ntsha alp hauv hlwb, txo cov ntshav qabzib ntau lawm. Hauv cov neeg mob uas muaj ntshav qab zib hom 2, qhov kev tso tawm ntawm GLP-1 tsawg dua, tab sis qhov tshuaj insulin rau GLP-1 tseem nyob. Saxagliptin, yog qhov muaj kev sib tw txhim kho ntawm DPP-4, txo qhov tsis muaj txiaj ntsig ntawm cov tshuaj hormones incretin, yog li ua rau lawv cov kev nkag siab hauv cov hlab ntshav thiab ua rau txo qis ntawm cov piam thaj tom qab noj mov.

Metformin
Metformin yog hom tshuaj hypoglycemic uas txhim kho cov kua nplaum ua haujlwm rau cov neeg mob ntshav qab zib hom 2, txo qis qis thiab tom qab cov ntshav qabzib feem ntau. Metformin txo qhov tsim tawm ntawm cov piam thaj los ntawm lub siab, txo qis kev nqus ntawm cov piam thaj hauv cov hnyuv thiab nce insulin rhiab heev, ua kom muaj qhov nqus ntau ntxiv thiab kev siv cov kua nplaum nyob. Tsis zoo li sulfonylurea kev npaj, metformin tsis ua rau cov ntshav qog ntshav qab zib hauv cov neeg mob ntshav qab zib hom 2 lossis cov neeg muaj mob noj qab haus huv (tshwj tsis yog muaj xwm txheej tshwj xeeb, saib rau cov nqe lus "Kev Ceeb Toom" thiab "Cov Lus Qhia Tshwj Xeeb"), thiab hyperinsulinemia. Thaum lub sij hawm kho cov tshuaj metformin, cov tshuaj insulin tsis hloov, txawm hais tias yoo insulin ceev thiab cov lus teb rau cov pluas noj thaum nruab hnub yuav tsawg zuj zus.

Cov chaw kuaj mob tau zoo thiab Kev Nyab Xeeb

Saxagliptin Hauv kev dig muag ob zaug, xaiv ib qho, tswj kev soj ntsuam, kev kho saxagliptin tau txais los ntawm ntau dua 17,000 tus neeg mob T2DM.

Qhov tshwm sim hlab plawv
SAVOR txoj kev tshawb nrhiav (Kev Ntsuam Xyuas Cov Ntshav plawv cov txiaj ntsig nyob rau hauv cov neeg mob ntshav qab zib noj Saxagliptin) tshuaj xyuas cov kev mob plawv hauv 16492 cov neeg mob T2DM (12959 cov neeg mob uas tau paub tseeb txog cov kab mob plawv (CVD), 3533 cov neeg mob uas muaj ntau yam kab mob plawv. vascular cov teeb meem) thiab cov txiaj ntsig ntawm 6.5% ≤ HbA1c 14 C-saxagliptin 24% ntawm cov koob tshuaj tau raug tso tawm los ntawm lub raum ua qhov hloov pauv saxagliptin thiab 36% yog qhov tseem ceeb ntawm kev siv tshuaj saxagliptin. Cov tshuaj tiv thaiv kab mob tag nrho hauv cov zis ntsuas rau 75% ntawm kev noj tshuaj. Qhov nruab nrab lub raum tshem tawm ntawm saxagliptin yog kwv yees li 230 ml / min, qhov nqi nruab nrab ntawm glomerular pom tau yog li 120 ml / min. Rau lub ntsiab metabolite, lub raum tshem tawm tau sib piv nrog lub txiaj ntsig tseem ceeb ntawm glomerular pom. Txog 22% ntawm tag nrho cov xov tooj cua tau pom nyob hauv cov quav.

Metformin
Cov hlaws hlaws hlaws muaj kwv yees li 3.5 npaug siab dua ntawm creatinine qhov kev tshem tawm (CC), uas qhia tau tias tubular zais zis yog txoj kev tseem ceeb ntawm kev nthuav tawm ntawm metformin.Tom qab kev tswj hwm ntawm qhov ncauj, kwv yees li 90% ntawm cov tshuaj nqus tau zoo dhau los ntawm lub raum thaum thawj 24 teev, nrog ib nrab-lub neej los ntawm ntshav ntawm kwv yees li 6.2 teev. Hauv cov ntshav, ib nrab-lub neej yog kwv yees li 17.6 teev, yog li ntawd, lub qe ntshav liab loj tuaj yeem yog ib feem ntawm txoj kev faib khoom.

Pharmacokinetics hauv cov chaw kho mob tshwj xeeb

Tsis hlauv
Nws tsis pom zoo kom siv Combogliz Prolong® rau cov neeg mob raum tsis ua haujlwm (saib Ntu "Kev Tshawb Xyuas Tsis Txaus").

Saxagliptin
Hauv cov neeg mob uas tsis tshua mob lub raum, AUC qhov tseem ceeb ntawm saxagliptin thiab nws cov metabolite yog 20% thiab 70% (feem ntau) siab dua AUC qhov tseem ceeb hauv cov neeg mob uas lub raum tsis ua haujlwm. Txij li qhov nce hauv tus nqi no tsis suav tias yog kev kho mob tseem ceeb, nws tsis pom zoo kom hloov cov tshuaj saxagliptin hauv cov neeg mob uas tsis mob ntsws tsis zoo.

Metformin
Hauv cov neeg mob uas lub raum tsis ua haujlwm (raws li cov txiaj ntsig ntawm QC kev ntsuas), ib nrab-lub neej ntawm metformin los ntawm ntshav thiab cov ntshav tawm thiab cov ntshav lub raum ua kom tsawg dua nyob rau hauv kev faib ua feem rau QC.

Saxagliptin
Hauv cov neeg mob uas tsis tshua muaj mob me me, mob nyhav thiab hnyav hnyav, tsis muaj kev hloov pauv ntau hauv cov chaw muag tshuaj ntawm saxagliptin, yog li kev kho kom haum rau cov neeg mob zoo li no tsis tas yuav ua.

Metformin
Tsis tau muaj cov tshuaj pharmacokinetic qhia txog cov tshuaj metformin hauv cov neeg mob uas tsis muaj mob rau daim siab.

Saxagliptin
Kev kho ntawm ib koob tshuaj saxagliptin nyob ntawm tus tub los ntxhais ntawm tus neeg mob tsis tas yuav.

Metformin
Hauv kev tshawb fawb soj ntsuam hauv cov neeg mob uas muaj ntshav qab zib hom 2, cov nyhuv ntshav qab zib ntau npaum li cas ntawm metformin hauv txiv neej thiab poj niam tau sib piv.

Saxagliptin
Hauv cov neeg mob 65-80 xyoo, tsis muaj qhov sib txawv hauv cov chaw muag tshuaj ntawm saxagliptin piv nrog cov neeg mob uas muaj hnub nyoog yau dua (18-40 xyoo), yog li ntawd yuav tsum tau txhaj tshuaj rau cov neeg laus laus tsis tas yuav tsum tau txhaj. Txawm li cas los xij, nws yuav tsum tau yug los rau hauv lub siab tias hauv pawg no ntawm cov neeg mob, qhov kev txo qis ntawm lub raum ua haujlwm ntau dua (saib ntu "Noj thiab Tswj Xyuas" thiab "Cov Lus Qhia Tshwj Xeeb").

Metformin
Tsuas siv cov ntaub ntawv los ntawm kev tshawb fawb soj ntsuam ntawm pharmacokinetics ntawm metformin hauv kev noj qab haus huv laus laus hais tias tag nrho cov ntshav ua kom meej meej ntawm metformin poob qis, kev tshem tawm ib nrab ntawm lub neej nce ntxiv, thiab Cmax nce piv rau qhov tseem ceeb ntawm cov kev txwv no hauv cov tub ntxhais hluas ua haujlwm zoo. Raws li cov ntaub ntawv no, kev hloov pauv hauv cov khw muag tshuaj ntawm metformin nrog rau lub hnub nyoog nce ntxiv yog vim muaj kev hloov pauv hauv lub raum kev ua haujlwm. Combogliz Prolong® yuav tsum tsis txhob raug rau cov neeg mob laus dua 80 xyoo, tshwj tsis yog lub qog ua haujlwm tsis zoo tau lees paub qhov txiaj ntsig ntawm QC ntsuas.

Saxagliptin
Kev tshawb fawb ntawm cov tshuaj pharmacokinetics ntawm saxagliptin hauv cov menyuam yaus tsis tau ua.

Metformin
Cov kev tshawb fawb ntawm pharmacokinetics ntawm metformin hloov kho tso tawm hauv cov menyuam yaus tsis tau ua.

Haiv neeg thiab Pab pawg

Saxagliptin Nws tsis pom zoo kom kho qhov koob tshuaj saxagliptin nyob ntawm tus neeg mob haiv neeg.

Metformin
Muaj tsis muaj kev tshawb fawb ntawm cov khw muag tshuaj ntawm metformin nyob ntawm seb haiv neeg twg ntawm cov neeg mob.

Hom 2 mob ntshav qab zib mellitus ua ke nrog kev noj haus thiab qoj ib ce kom txhim kho glycemic tswj.

TSWJ SIB LWM

Nce ib tug neeg rhiab rau ib feem ntawm cov tshuaj,
Cov tshuaj tiv thaiv tsis haum qhov hnyav (anaphylaxis lossis angioedema) rau DPP-4 cov tshuaj tiv thaiv kab mob,
Yam 1 ntshav qab zib mellitus (siv tsis tau kawm)
Siv cov tshuaj insulin (tsis kawm)
Congenital galactose intolerance, lactase deficiency thiab qabzib-galactose malabsorption,
Cev xeeb tub, lactation,
Muaj hnub nyoog txog 18 xyoo (kev nyab xeeb thiab kev kawm tsis tau zoo),
Lub raum khiav tsis zoo (ntshav dej creatinine ≥1.5 mg / dL rau cov txiv neej, ≥1.4 mg / dL rau cov poj niam lossis txo qis creatinine), suav nrog cov mob los ntawm kev mob plawv tsis ua haujlwm (poob siab), mob myocardial infarction thiab septicemia,
Cov mob hnyav uas muaj qhov pheej hmoo ntawm lub raum ua haujlwm: lub cev qhuav dej (nrog rau ntuav, raws plab), kub taub hau, mob hnyav kis, mob ntawm hypoxia (poob siab, sepsis, mob raum, kab mob bronchopulmonary),
Mob lossis mob ntsws metabolic acidosis, nrog rau ketoacidosis uas mob ntshav qab zib, nrog lossis tsis nco qab lawm
Clinically qhia qhov tseeb ntawm cov mob huam thiab mob ntev tuaj yeem ua rau kev tsim cov nqaij mos hypoxia (ua pa tsis ua haujlwm, lub plawv tsis ua haujlwm, mob myocardial infarction),
Kev phais hnyav thiab raug mob (thaum kho mob insulin)
Daim siab ua haujlwm tsis zoo,
Kev haus cawv ntev ntev thiab qaug cawv lom,
Lactic acidosis (suav nrog keeb kwm),
Lub sijhawm tsawg kawg 48 teev ua ntej thiab nyob rau hauv 48 teev tom qab ua kev tshawb fawb radioisotope lossis xoo hluav taws xob nrog kev qhia ntawm iodine-uas muaj cov tshuaj sib piv,
Ua raws Kev Noj Mov Qis Calorie (Cov Neeg Mob Laus
Txij li thaum saxagliptin thiab metformin raug qee tawm los ntawm lub raum, thiab hauv cov neeg laus cov neeg mob lub raum ua haujlwm tsawg dua, feem ntau Combogliz Prolong® yuav tsum siv nrog kev ceev faj rau cov neeg laus.

Saxagliptin
Tsis muaj qhov sib txawv hauv kev nyab xeeb lossis kev ua tau zoo ntawm cov tshuaj hauv cov neeg mob> 65 xyoo,> 75 xyoo, thiab cov neeg mob hluas.
Metformin
Cov kev tshawb fawb soj ntsuam txog metformin tsis suav nrog cov neeg muaj hnub nyoog txaus los txiav txim siab qhov sib txawv hauv cov lus teb rau kev kho mob piv rau cov neeg mob hluas, txawm hais tias cov kev kho mob tsis tsim kev sib txawv hauv cov lus teb rau cov neeg laus thiab cov hluas. Raws li koj paub, metformin feem ntau ua rau lub raum tawm, thiab yog li ntawd muaj kev pheej hmoo ntawm kev tsim muaj cov kev tsis zoo hauv cov neeg mob raum tsis ua haujlwm. Combogliz Prolong® yuav tsum tau kho tsuas yog rau cov neeg mob uas lub raum tsis ua haujlwm. Thawj zaug thiab kev saib xyuas cov tshuaj metformin yuav tsum raug muab rau cov neeg laus laus, suav nrog qhov txo qis hauv lub raum kev ua haujlwm. Qhov kev hloov kho koob tshuaj twg yuav tsum tau ua tom qab kev soj ntsuam ceev faj ntawm lub raum ua haujlwm.

Cov kev nyab xeeb thiab kev ua tau zoo ntawm cov tshuaj hauv cov neeg mob hnub nyoog qis dua 18 xyoo tsis tau kawm.

Tej yam tsis zoo

Cov nyom tsis haum hauv cov tshuaj tshawb glycemic thaum sivsaxagliptin hauv kev kho tshuaj thiab thaum ntxiv rau lwm yam tshuaj

Saxagliptin
Cov lus 1 qhia txog cov xwm txheej tsis zoo uas tau pom thaum kuaj sim (tsis hais seb tus kws tshawb xyuas soj ntsuam qhov ua rau raug mob puas tsuaj) hauv ≥5% ntawm cov neeg mob tau txais saxagliptin 5 mg, thiab nrog rau qhov siab dua li cov pawg placebo, raws li kev soj ntsuam ntawm 24-lub lim tiam tshawb nrhiav Cov.

Rooj 1. Cov xwm txheej phem

Saxagliptin5mgN = 882

Tso cov tshuajN = 799

Sab saud mob ntsws

Mob txeeb zig

Lub 5 cov kev siv tshuaj placebo nyob rau hauv qhov kev tsom xam no yog ob qho kev tshawb fawb monotherapy thiab ib qho kev kawm ua ke nrog kev kawm ntxiv nrog saxagliptin rau metformin, thiazolidinedione lossis glibenclamide. Hauv cov neeg mob noj saxagliptin ntawm koob tshuaj 2.5 mg, mob taub hau (6.5%) tsuas yog qhov kev tshwm sim tsis zoo uas tau sau tseg nrog qhov zaus ntawm> 5%, thiab tau tsim kho ntau dua li cov pab pawg placebo.

Raws li kev tshawb xyuas tib yam kev sib xyaw, cov kev pom tsis zoo tshwm sim hauv> 2% ntawm cov neeg mob noj saxagliptin ntawm koob tshuaj 2.5 mg lossis saxagliptin ntawm koob tshuaj 5 mg thiab kev tsim kho> 1% ntau zaus ntau dua li ntawm cov pawg placebo suav nrog kev mob sinusitis (2, 9% thiab 2.6% piv nrog 1.6%, ntu), mob plab (2.4% thiab 1.7% piv nrog 0.5%), mob ncauj plab (1.9% thiab 2.3) % piv nrog 0.9%) thiab ntuav (2.2% thiab 2.3% piv nrog 1.3%).

Qhov tshwm sim ntawm qhov pob txha tawg yog 1.0 thiab 0.6 rau 100 tus neeg mob-xyoo, ntsig txog, thaum noj saxagliptin (kev sib xyaw ua ke ntawm kev tshuaj ntsuam ntawm 2.5 mg, 5 mg thiab 10 mg) thiab placebo. Qhov ntau zaus ntawm cov pob txha lov rau cov neeg mob noj saxagliptin tsis tau nce ntxiv thaum lub sijhawm ua haujlwm. Ib qho kev sib raug zoo tsis txaus ntseeg, thiab kev kawm ua ntej tsis tau qhia txog qhov tsis xav tau ntawm saxagliptin ntawm cov nqaij mos.

Thaum lub sijhawm kho mob pabcuam, kev txhim kho thrombocytopenia coj los ntsuas tus kab mob ntawm idiopathic thrombocytopenic purpura tau pom. Cov kev sib txuas ntawm kev txhim kho ntawm qhov tshwm sim no thiab kev coj ntawm saxagliptin tsis paub.

Cov xwm txheej tsis zoo uas cuam tshuam nrog kev tswj hwm ntawm saxagliptin thiab metformin hauv kev kho cov neeg mob uas muaj ntshav qab zib hom 2 uas tsis tau txais kev kho yav tas los hauv kev tshawb fawb glycemic tswj.Saxagliptin
Cov lus 2 qhia txog cov xwm txheej tsis zoo uas tau pom (tsis hais txog kev sib raug zoo los ntawm kev tshawb fawb) nyob rau hauv ≥ 5% ntawm cov neeg mob koom nrog kev kawm ntxiv 24-lub lim tiam nrog kev tswj hwm ntawm kev siv tshuaj saxagliptin thiab metformin hauv cov neeg mob uas tsis tau txais kev kho yav tas los.

Rooj ntawv 2. Cov xwm txheej tsis zoo

Kom muaj nuj nqis(%)ntawm cov neeg mob

Saxagliptin5mg+metformin*N = 320

Metformin* N = 328

* Qhov tshuaj tiv thaiv thaum pib ntawm metformin 500 mg / hnub tau nce ntxiv rau qhov ntau kawg ntawm 2000 mg / hnub.

Hauv cov neeg mob tau txais saxagliptin ntxiv rau kev kho mob metformin los yog raws li kev kho ua ke thaum pib, raws plab yog qhov kev mob plab nkaus xwb uas tau tsim kho hauv ≥ 5% ntawm cov neeg mob hauv ib pawg. Qhov tshwm sim ntawm kev mob plab zom mov yog 9.9%, 5.8% thiab 11.2% hauv saxagliptin pawg 2.5 mg, saxagliptin 5 mg thiab placebo, ntsig txog, hauv kev kawm txog kev ntxiv ntawm saxagliptin rau metformin, qhov tshwm sim ntawm mob plab zawv yog 6.9% thiab 7.3% hauv kev sib koom ua ke nrog pab pawg nrog saxagliptin 5 mg thiab metformin thiab metformin monotherapy pawg hauv kev kawm txog kev pib ua ke nrog kev kho mob nrog metformin.

Kev ntshav siab

Saxagliptin
Cov ntaub ntawv hais txog hypoglycemia yog qhov tshwm sim tsis zoo tau sau los ntawm cov lus ceeb toom ntawm hypoglycemia; tsis muaj qhov ntsuas qhov tsis zoo ntawm cov piam thaj hauv qab. Qhov tshwm sim ntawm kev mob ntshav qab zib nrog kev siv saxagliptin 2.5 mg, saxagliptin 5 mg thiab placebo (txhua yam raws li kev kho mob monotherapy) yog 4%, 5.6% thiab 4.1%, thiab, 7.8%, 5.8% thiab 5 %, feem, nrog ntxiv ntawm metformin. Qhov tshwm sim ntawm kev mob ntshav qab zib yog 3.4% hauv cov neeg mob uas tsis tau kho dua yav dhau los uas siv tshuaj saxagliptin ntawm koob tshuaj 5 mg rau hauv kev sib xyaw nrog metformin, thiab 4% hauv cov neeg mob ntawm metformin monotherapy.

Kev ua haujlwm tsis haum siab

Saxagliptin
Hauv kev soj ntsuam ntawm tsib qhov kev tshawb fawb, qhov kev tshwm sim tsis zoo uas cuam tshuam nrog kev mob siab (xws li urticaria thiab ntsej muag ntawm lub ntsej muag) tau pom hauv 1.5%, 1.5% thiab 0.4% ntawm cov neeg mob tau txais saxagliptin ntawm koob tshuaj 2.5 mg, saxagliptin ntawm koob tshuaj 5 mg thiab placebo, feem. Raws li cov kws tshawb nrhiav, tsis muaj ib qho tshwm sim hauv cov neeg mob uas tau txais saxagliptin yuav tsum tau mus pw hauv tsev kho mob thiab tsis tau hem lub neej ntawm cov neeg mob. Hauv cov ntaub ntawv tshawb xyuas no, ib tus neeg mob uas tau txais saxagliptin tau raug cais tawm ntawm txoj kev tshawb fawb vim kev txhim kho dav dav urticaria thiab ntsej muag.

Qhov ntsuas ntawm lub zog ua haujlwm

Saxagliptin
Hauv cov neeg mob uas tau txais saxagliptin raws li kev kho mob monotherapy lossis hauv kev sib xyaw nrog metformin, tsis muaj kev hloov pauv hauv lub zog hauv lub zog tau qhia tawm.

Kev Kho Mob Kho Mob

Metformin
Hauv kev soj ntsuam cov tshuaj placebo, qhov xwm txheej tshwm sim ntau tshaj plaws uas tau pom hauv> 5% ntawm cov neeg mob tau txais cov tshuaj metformin uas tau hloov kho thiab nthuav dav ntau dua li ntawm cov pawg placebo yog zawv plab thiab xeev siab / ntuav.

Kev Phom Sij Saxagliptin Kev Phom Sij rau Txoj Kev Tshawb Fawb

Hauv SAVOR txoj kev tshawb nrhiav, 8240 cov neeg mob tau txais saxagliptin ntawm koob tshuaj 2.5 mg lossis 5 mg ib hnub ib zaug, thiab 8173 cov neeg mob tau txais placebo.Lub sijhawm nruab nrab ntawm kev kho saxagliptin, tsis hais txog kev cuam tshuam hauv kev kho, yog 1.8 xyoo. Hauv 3698 cov neeg mob (45%), lub sijhawm rau kev kho saxagliptin yog 2-3 xyoos. Tag nrho qhov tshwm sim ntawm qhov tshwm sim tsis zoo hauv qhov kev kawm no hauv cov pab pawg ntawm cov neeg mob noj saxagliptin (72.5%) piv rau qhov xwm txheej tshwm sim tsis zoo hauv cov pawg placebo (72.2%).

Qhov ntau zaus ntawm kev ncua kev kho mob vim tias qhov tshwm sim tsis zoo yog qhov sib piv ntawm cov neeg mob noj saxagliptin (4.9%) thiab cov placebo (5%). SAVOR txoj kev tshawb fawb soj ntsuam cov txiaj ntsig ntawm saxagliptin ntawm kev tshwm sim ntawm cov mob plawv. Ntxiv rau saxagliptin rau kev kho mob tsis tau pom tias yuav ua rau muaj kev pheej hmoo ntawm cov hlab plawv mob (xws li lub plawv kev tuag, tsis yog mob ntshav ntawm lub cev tsis ua haujlwm, tsis yog ischemic mob stroke) hauv cov neeg mob T2DM piv nrog placebo (RR 1.00, 95% CI 0, 89, 1.12, P Tsis muaj pes tsawg tus lymphocytes

Saxagliptin
Thaum siv saxagliptin, ib koob tshuaj tiv thaiv qhov nruab nrab txo qis hauv tus naj npawb ntawm lymphocytes tau pom. Thaum txheeb xyuas cov ntaub ntawv sib xyaw ua ke ntawm tsib 24-lub lis piam, cov kev tshawb fawb tshuaj placebo, qhov nruab nrab txo ntawm kwv yees li 100 thiab 120 hlwb / ofl ntawm tus naj npawb ntawm lymphocytes los ntawm thawj tus naj npawb ntawm 2200 hlwb / wasl tau pom nrog saxagliptin ntawm koob tshuaj 5 mg thiab 10 mg, feem, piv nrog placebo Cov. Cov txiaj ntsig zoo sib xws tau pom thaum noj saxagliptin ntawm koob tshuaj 5 mg hauv kev pib ua ke nrog metformin piv nrog metformin monotherapy. Tsis muaj qhov sib txawv ntawm 2.5 mg saxagliptin thiab placebo. Qhov kev faib ua feem ntawm cov neeg mob uas tus naj npawb ntawm lymphocytes yog ≤ 750 hlwb / wasl yog 0.5%, 1.5%, 1.4%, thiab 0.4% hauv saxagliptin kho pawg mob ntawm koob tshuaj 2.5 mg, ntawm koob tshuaj 5 mg , ntawm ib koob ntawm 10 mg thiab placebo, ntsig txog. Hauv cov neeg mob feem ntau uas rov qab siv saxagliptin, tsis muaj kev cuam tshuam rov qab tshwm sim, txawm hais tias nyob hauv qee tus neeg mob cov lymphocytes poob qis dua thaum rov pib kho nrog saxagliptin, uas ua rau muaj kev tshem tawm saxagliptin. Qhov txo qis hauv cov lymphocytes tsis tau nrog cov kev ua kom pom.

Hauv SAVOR txoj kev tshawb nrhiav, qhov kev txo qis ntawm cov lymphocytes hauv saxagliptin pawg tau pom nyob hauv 0.5% ntawm cov neeg mob, hauv pawg placebo - hauv 0.4% ntawm cov neeg mob.

Saxagliptin
Saxagliptin tsis muaj qhov tshwm sim hauv kev kho mob hauv platelet ntau hauv rau ob qhov dig muag, tswj qhov kev soj ntsuam kev nyab xeeb thiab ua tau zoo.

Vitamin B12 Concentration

Hauv kev tswj xyuas cov chaw kho mob ntawm cov tshuaj metformin kav ntev li 29 lub lis piam, kwv yees li 7% ntawm cov neeg mob tau txo qis cov ntshav qis dua cov ntsiab lus ntawm cov vitamin B12 rau cov nqi tsis tseem ceeb yam tsis muaj kev kuaj mob. Txawm li cas los xij, ib qho kev txo qis no tsis tshua muaj nrog los ntawm kev txhim kho ntawm lub cev tsis muaj zog thiab rov qab sai sai tom qab tshem tawm ntawm metformin lossis kev noj cov tshuaj vitamin B12 ntxiv.

OVERDOSE

Nrog lub sijhawm ntev ntawm kev siv cov tshuaj hauv cov koob tshuaj kom txog 80 zaug siab dua qhov kev pom zoo, cov tsos mob ntawm intoxication tsis tau piav qhia.

Metformin
Muaj qee tus neeg mob haus ntshav ntau tshaj ntawm cov tshuaj metformin, suav nrog kev noj ntau dua 50 g. Hauv 32% ntawm cov neeg haus tshuaj ntau tshaj ntawm metformin, cov neeg mob tau mob lactic acidosis. Metformin raug tawm hauv kev lim ntshav, thaum lub sijhawm meej txog 170 ml / min.

Cuam tshuam nrog lwm yam tshuaj thiab lwm yam li kev cuam tshuam

Saxagliptin metabolism feem ntau yog kev sib kho los ntawm cytochrome P450 3A4 / 5 isoenzyme system (CYP3A4 / 5). Hauv cov kev tshawb fawb hauv vitro tau pom tias saxagliptin thiab nws cov metabolite tseem ceeb tsis tiv thaiv CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 thiab 3A4 isoenzymes thiab tsis txhob ntxias CYP1A2, 2B6, 2C9, thiab 3A4 isoenzymes. Yog li, cov txiaj ntsig ntawm saxagliptin ntawm kev zom zaub mov hauv cov tshuaj hauv cov metabolism hauv uas cov isoenzymes no koom tes tsis tuaj yeem xav tau thaum lawv siv ua ke. Saxagliptin tsis yog qhov tseem ceeb inhibitor lossis inducer ntawm P-gp.

Metformin
Qee cov tshuaj nce hyperglycemia (thiazide thiab lwm yam diuretics, glucocorticosteroids, phenothiazines, kev npaj ntawm iodine-muaj cov thyroid hormones, estrogens, qhov ncauj tawm tsam, phenytoin, nicotinic acid, sympathomimetics, qeeb calcium channel blockers thiab isoniazid). Thaum sau tshuaj lossis tso tseg cov tshuaj no rau hauv tus neeg mob noj Combogliz Prolong®, cov ntshav qabzib concentration yuav tsum ua tib zoo saib. Qhov sib khi ntawm metformin rau cov ntshav plasma proteins muaj tsawg, yog li nws tsis pom zoo tias nws yuav cuam tshuam nrog cov tshuaj uas cuam tshuam rau cov ntshav plasma protein ntau, xws li salicylates, sulfonamides, chloramphenicol thiab probenecid (hauv kev sib piv ntawm sulfonylurea derivatives, uas muaj ntau yam tseem ceeb) nrog cov ntshiab protein).

Qhov ntsuas ntawm isoenzymes CYP3A4 / 5

Saxagliptin
Rifampicin cuam tshuam txo qis kev cuam tshuam ntawm saxagliptin yam tsis hloov AUC ntawm nws cov nquag metabolite, 5-hydroxy-saxagliptin. Rifampicin tsis cuam tshuam rau qhov kev txwv tsis pub DPP-4 nyob rau hauv cov ntshav ntshav thaum lub sijhawm 24-teev kev kho mob.

CYP3A4 / 5 Isoenzyme Tus Neeg Txom Nyem

Saxagliptin
Diltiazem txhim kho kev muaj txiaj ntsig ntawm saxagliptin thaum siv ua ke. Kev nce siab ntawm saxagliptin nyob rau hauv cov ntshav ntshav yog yuav tsum siv amprenavir, aprepitant, erythromycin, fluconazole, fosamprenavir, kua txiv kab ntxwv qaub thiab verapamil, txawm li cas los xij, koob tshuaj saxagliptin tsis pom zoo.

Ketoconazole ua rau ntau cov kev xav ntawm saxagliptin hauv ntshav. Ib qho zoo sib xws tseem ceeb ntxiv rau qhov kev txiav txim ntawm saxagliptin hauv cov ntshav ntshav yog xav tau thaum lwm qhov muaj zog tiv thaiv ntawm CYP3A4 / 5 isoenzymes siv (piv txwv, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir). Thaum muab sib xyaw nrog ib qho muaj zog inhibitor ntawm CYP3A4 / 5 isoenzymes, qhov koob tshuaj saxagliptin yuav tsum txo kom tsawg li 2.5 mg.

Metformin
Cov tshuaj Cationic (piv txwv li, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamteren, trimethoprim lossis vancomycin), uas yog tawm los ntawm lub raum los ntawm kev lim ntshav, txhawm rau qhov kev sib txuas lus nrog metformin, sib tw rau cov kev thauj mus los ntawm cov leeg. Hauv kev tshawb fawb txog kev sib cuam tshuam yeeb tshuaj ntawm metformin thiab cimetidine nrog ib zaug thiab rov ua dua ntawm cov tshuaj, metformin thiab cimetidine tau pom thaum muab cov lus hauv cov neeg ua haujlwm noj qab haus huv, nrog 60% nce ntxiv ntawm qhov siab tshaj plaws ntawm metformin hauv plasma thiab tag nrho cov ntshav thiab nce 40% hauv AUC ntawm metformin hauv plasma thiab tag nrho ntshav. Thaum lub sij hawm kawm nrog ib zaug tshuaj ntawm cov tshuaj, tsis muaj kev hloov pauv hauv ib nrab-lub neej. Metformin tsis cuam tshuam rau pharmacokinetics ntawm cimetidine. Nws raug nquahu kom ua tib zoo saib xyuas cov neeg mob thiab, yog tias tsim nyog, kho cov koob tshuaj rau cov neeg mob noj tshuaj cationic uas raug tso tawm los ntawm qhov siab nyob ze lub plab hlaub.

Metformin
Hauv kev kawm txog kev sib cuam tshuam nrog kev txhaj tshuaj ib zaug hauv cov neeg mob ntshav qab zib hom 2, kev sib xyaw ntawm kev siv tshuaj metformin thiab glibenclamide tsis cuam tshuam rau pharmacokinetics lossis pharmacodynamics.

Metformin
Hauv kev kawm txog kev sib cuam tshuam yeeb tshuaj ntawm metformin thiab furosemide nrog ib zaug ntawm cov tshuaj, ua rau cov neeg ua haujlwm noj qab haus huv, lawv cov kev sib raug zoo pharmacokinetic tau qhia. Furosemide nce Cmax ntawm metformin hauv plasma thiab ntshav los ntawm 22% thiab AUC hauv ntshav 15% yam tsis muaj kev hloov pauv tseem ceeb hauv kev ua haujlwm ntawm lub raum tshem tawm ntawm metformin. Thaum ua ke nrog metformin, Cmax thiab AUC ntawm furosemide txo los ntawm 31% thiab 12%, feem, thiab ib nrab lub neej txo qis los ntawm 32% yam tsis muaj qhov pom kev hloov hauv lub raum tshem ntawm furosemide. Tsis muaj cov ntaub ntawv hais txog kev cuam tshuam ntawm metformin thiab furosemide nrog ua ke siv ntev.

Metformin
Hauv kev kawm txog kev sib cuam tshuam yeeb tshuaj ntawm metformin thiab nifedipine nrog ib zaug ntawm cov tshuaj, nqa tawm nrog kev koom tes ntawm cov neeg tuaj yeem noj qab haus huv, nifedipine nce Cmax ntawm plasma metformin los ntawm 20% thiab AUC los ntawm 9%, thiab nce ntxiv los ntawm lub raum. Tmax thiab tshem tawm ib nrab-lub neej tsis hloov pauv. Nifedipine tsub kom ntau ntxiv kev nqus ntawm metformin. Metformin tsis muaj kev cuam tshuam zoo li ntawm cov tshuaj pharmacokinetics ntawm nifedipine.

Saxagliptin thiab Metformin
Kev sib xyaw ntawm kev siv ib zaug ntawm saxagliptin (100 mg) thiab metformin (1000 mg) tsis muaj kev cuam tshuam ntau yam ntawm cov tshuaj pharmacokinetics ntawm saxagliptin lossis metformin hauv cov neeg ua haujlwm noj qab haus huv. Tsis muaj kev kawm tshwj xeeb pharmacokinetic txog kev sib txuam nrog tshuaj nrog kev siv ntawm Combogliz Prolong® tau ua, txawm hais tias cov kev tshawb fawb no tau ua nrog nws cov khoom siv: saxagliptin thiab metformin.

Cov nyhuv ntawm lwm cov tshuaj ntawm saxagliptin

Glibenclamide: Kev sib xyaw ua ke siv ib qho saxagliptin (10 mg) thiab glibenclamide (5 mg), ib qho pauv ntawm CYP2C9 isoenzyme, nce Cmax ntawm saxagliptin los ntawm 8%, tab sis AUC ntawm saxagliptin tsis hloov pauv.
Pioglitazone: Kev sib xyaw ua ke rov qab siv saxagliptin ib zaug ib hnub (10 mg) thiab pioglitazone (45 mg), ib qho keeb ntawm isoenzyme CYP2C8 (muaj zog) thiab CYP3A4 (qaug zog), tsis cuam tshuam rau pharmacokinetics ntawm saxagliptin.
Digoxin: Kev sib xyaw ua ke rov qab siv saxagliptin ib zaug ib hnub (10 mg) thiab digoxin (0.25 mg), ib qho tshuaj P-glycoprotein, tsis cuam tshuam rau lub pharmacokinetics ntawm saxagliptin.
Simvastatin: Kev sib xyaw ua ke rov qab siv saxagliptin ib zaug ib hnub (10 mg) thiab simvastatin (40 mg), ib qho pauv ntawm CYP3A4 / 5 isoenzymes, nce Stax ntawm saxagliptin los ntawm 21%, tab sis AUC ntawm saxagliptin tsis hloov pauv.
Diltiazem: Kev sib xyaw ua ke siv ib qho saxagliptin (10 mg) thiab diltiazem (360 mg ntev npaum li cas daim ntawv tshuaj nyob rau hauv kev sib npaug), cov tshuaj tsis haum ntawm CYP3A4 / 5 isoenzymes, nce Stax ntawm saxagliptin los ntawm 63%, thiab AUC los ntawm 2.1 zaug. Qhov no yog nrog los ntawm qhov txo qis hauv Stax thiab AUC ntawm cov metabolite nquag los ntawm 44% thiab 36%, feem.
Ketoconazole: Kev siv sib xyaw ua ke ntawm ib koob tshuaj saxagliptin (100 mg) thiab ketoconazole (200 mg txhua 12 teev hauv kev sib npaug) nce Stax thiab AUC ntawm saxagliptin 2.4 thiab 3.7 npaug, ntsig txog. Qhov no yog nrog los ntawm qhov txo qis hauv Stax thiab AUC ntawm cov metabolite nquag los ntawm 96% thiab 90%, feem.
Rifampicin: Kev sib xyaw ntawm kev siv ib koob tshuaj saxagliptin (5 mg) thiab rifampicin (600 mg ib hnub ib zaug hauv kev sib npaug) txo Stax thiab AUC ntawm saxagliptin los ntawm 53% thiab 76%, feem ntau, nrog sib luag nce hauv Stax (39%), tab sis tsis muaj qhov hloov pauv tseem ceeb hauv AUC nquag metabolite.
Omeprazole: Kev siv ntau yam tshuaj saxagliptin ntawm koob tshuaj 10 mg ib hnub ib zaug thiab omeprazole ntawm ib koob 40 mg, ib qho me me ntawm isoenzyme CYP2C19 (muaj zog) thiab isoenzyme CYP3A4 (qaug zog), ib qho inhibitor ntawm isoenzyme CYP2C19 thiab cov tshuaj tiv thaiv mob MRP-3, tsis cuam tshuam.

Aluminium hydroxide + magnesium hydroxide + simethicone:
Kev siv tshuaj ib leeg ntawm saxagliptin (10 mg) thiab kev ncua uas muaj txhuas hydroxide (2400 mg), magnesium hydroxide (2400 mg) thiab simethicone (240 mg) txo Stax ntawm saxagliptin los ntawm 26%, txawm li cas los xij, saxagliptin AUC tsis hloov.

Famotidine: Noj ib koob tshuaj saxagliptin (10 mg) 3 teev tom qab ib koob noj cov tshuaj famotidine (40 mg), ib qho inhibitor ntawm hOCT-1, hOCT-2, thiab hOCT-3, nce Cmax ntawm saxagliptin los ntawm 14%, txawm li cas los xij, saxagliptin AUC tsis hloov.

Tso tawm daim ntawv thiab muaj pes tsawg leeg

Daim ntawv tshuaj npaum li cas - hloov cov ntsiav tshuaj tso tawm, zaj duab xis-txheej (hauv daim duab los qhia 4 lub hlwv ntawm 7 ntsiav tshuaj thiab cov lus qhia rau kev siv Combolize Prolong, ntxiv rau cov ntsiav tshuaj ntawm 1000 + 2.5 mg - 8 blisters ntawm 7 ntsiav tshuaj):

qhov ntau npaum 1000 mg + 2.5 mg: tshuaj ntsiav zoo li tus, biconvex, zaj duab xis txheej los ntawm daj ntseg mus rau lub teeb daj, nrog tus xaum xiav ntawm ib sab sau ntawv "2.5 / 1000", nyob rau sab nraud - "4222",
ntau npaum 500 mg + 5 mg: tshuaj ntsiav zoo li tus, biconvex, zaj duab xis txheej los ntawm lub teeb xim av mus rau xim av, nrog tus cwj mem xiav ntawm ib sab yog sau "5/500", nyob rau sab nraud - "4221",
ntau npaum 1000 mg + 5 mg: tshuaj ntsiav zoo li tus, biconvex, xim zaj duab xis lub tsho tiv no, tus cwj mem xiav ntawm ib sab yog sau "5/1000", ntawm ib sab - "4223".

Yam tshuaj muaj nyob hauv 1 ntsiav tshuaj:

metformin hydrochloride - 1000 mg + saxagliptin - 2.5 mg,
metformin hydrochloride - 500 mg + saxagliptin - 5 mg,
metformin hydrochloride - 1000 mg + saxagliptin - 5 mg.

Kev sib xyaw rau hauv ib ntsiav tshuaj nrog qhov hloov pauv tawm, zaj duab xis-coated (1000 mg + 2.5 mg / 500 mg + 5 mg / 1000 mg + 5 mg):

ntsiav tshuaj tub ntxhais: metformin hydrochloride nyob rau hauv kev sib xyaw nrog 0.5% magnesium stearate - 1005 / 502.5 / 1005 mg, sodium carmellose - 50/50/50 mg, hypromellose 2208 - 393/358/393 mg, hypromellose 2910 - 0/10 / 0 mg, magnesium stearate - 2/1/2 mg, microcrystalline cellulose - 0/102/0 mg,
thawj lub tsho tiv no txheej (tiv thaiv): Opadry II dawb (% m / m) - 130.5 / 99 / 130.5 mg (qee cov kua dej polyvinyl cawv - 40%, titanium dioxide - 25%, macrogol 3350 - 20.2% , talc - 14.8%), 1M daws cov hydrochloric acid - txog pH 2 ± 0.3,
qhov thib ob txheej ntawm lub plhaub txheej (nquag): saxagliptin - 2.5 / 5/5 mg, Opadry II dawb - 20/20/20 mg, 1M daws ntawm hydrochloric acid - txog pH 2 ± 0.3,
mem kua rau inscription: Opacode xiav number case (% m / m) - 0.03 / 0.03 / 0.03 mg (indigo carmine txhuas kua roj vanish - 16%, shellac

45% hauv ethanol - 55.4%, butanol - 15%, propylene glycol - 10.5%, isopropanol - 3%, 28% daws ntawm ammonium hydroxide - 0.1%).

Qhov thib peb (xim) txheej ntawm lub plhaub txheej:

1000 + 2.5 mg: Opadry II daj (% m / m) - 48 mg (ib nrab dej cawv polyvinyl cawv - 40%, titanium dioxide - 24.25%, macrogol 3350 - 20.2%, talc - 14.8% , daj zas hlau oxide - 0.75%), 1M hydrochloric acid kua - txog pH 2 ± 0.3,
1000 + 5 mg: Opadry II tan (% m / m) - 33 mg (muaj feem nrog cov dej cawv polyvinyl cawv - 40%, macrogol 3350 - 20.2%, titanium dioxide - 19.58%, talc - 14.8% , daj zas hlau oxide - 5%, xim liab zas hlau oxide - 0.42%), 1M hydrochloric acid kua - txog pH 2 ± 0.3,
500 + 5 mg: Opadry II liab dawb (% m / m) - 48 mg (ib nrab dej cawv polyvinyl cawv - 40%, titanium dioxide - 24.25%, macrogol 3350 - 20.2%, talc - 14.8%, liab zas hlau oxide - 0.75%), 1M daws ntawm hydrochloric acid rau ib pH ntawm 2 ± 0.3.

COV LUS QHIA TSHWJ XEEB

Lactic acidosis

Cov kab mob lactic acidosis yog ib qho mob tsis txaus, ua rau cov metabolic hnyav uas tuaj yeem tsim los ntawm kev ua kom tiav ntawm metformin thaum kho nrog Combogliz Prolong®. Nrog rau kev txhim kho ntawm cov kab mob lactic acidosis vim yog siv cov tshuaj metformin, nws cov tshuaj lom neeg hauv cov ntshav ntshav ntau dua 5 μg / ml.

Kev tshuaj xyuas raum tsis tu ncua ntawm cov neeg mob uas siv cov tshuaj metformin yuav tsum tau ua thiab qhov kev txhaj tshuaj metformin tsawg kawg yuav tsum tau ua. Hauv cov neeg laus cov neeg mob, kev tshuaj xyuas lub raum kev ua haujlwm yog qhov tsim nyog. Metformin yuav tsum tsis txhob raug rau cov neeg mob hnub nyoog 80 xyoo thiab laus dua yog tias lub raum ua haujlwm tsis zoo (raws li QC cov ntaub ntawv), vim tias cov neeg mob no muaj kev tiv thaiv mob lactic acidosis ntau dua.Ntxiv rau, metformin kev kho mob yuav tsum tau txiav tawm tam sim ntawd yog tias muaj mob nrog hypoxemia, lub cev qhuav dej lossis mob sepsis. Txij li lub siab tsis ua haujlwm tuaj yeem txwv tsis muaj peev xwm ua kom tsis muaj zog ntau dua lactate, metformin yuav tsum tsis txhob raug rau cov neeg mob uas kuaj mob lossis kuaj pom tias muaj kab mob siab.

Yuav tsum kuaj xyuas txhua tus neeg mob ntshav qab zib mellitus thiab cov kab mob metabolic acidosis yam tsis muaj ketoacidosis (ketonuria thiab ketonemia).

Lactic acidosis xav tau kev kho mob hauv tsev kho mob teeb tsa. Yog tias lactic acidosis raug kuaj pom hauv tus neeg mob noj cov tshuaj metformin, koj yuav tsum tsis txhob noj tshuaj tam sim ntawd thiab pib ntsuas cov kev txhawb nqa dav dav. Nws raug nquahu tias kev lim ntshav yuav tsum tau pib tam sim kom kho acidosis thiab ua rau muaj cov metformin ntau ntxiv.

Raws li koj paub, cawv potentiates cov nyhuv ntawm metformin rau cov lactate metabolism, uas ua rau muaj kev pheej hmoo ntawm cov kab mob lactic acidosis. Txo kev haus cawv ntau thaum siv Combogliz Prolong®.

Daim siab ua haujlwm

Kev siv ntawm Combogliz Prolong® yog contraindicated rau hauv cov neeg mob uas kuaj thiab kuaj pom ntawm daim siab mob vim muaj kev pheej hmoo ntawm lactic acidosis.

Kev ntsuam xyuas lub raum kev ua haujlwm

Ua ntej pib kho nrog Combogliz Prolong® thiab tsawg kawg ib xyoos ib zaug tom qab ntawd, nws yog qhov yuav tsum tau kuaj xyuas lub raum kev ua haujlwm. Hauv cov neeg mob uas xav tias lub raum khiav tsis zoo, lub raum kev ua haujlwm yuav tsum raug ntsuas ntau dua thiab kev kho nrog Combogliz Prolong® yuav tsum tsis ua haujlwm yog tias cov cim ntawm lub raum tsis ua haujlwm tshwm sim.

Cov txheej txheem phais

Koj yuav tsum tau tsum ib ntus noj cov tshuaj Combogliz Prolong® ua ntej txhua txoj kev phais mob (tshwj tsis yog cov txheej txheem me me uas tsis muaj feem ntsig txog kev txwv cov zaub mov thiab kua dej), thiab tsis rov pib siv nws kom txog thaum tus neeg mob tuaj yeem noj cov tshuaj hauv thiab ua haujlwm li qub tau lees paub. ob lub raum.

Hloov pauv mus rau lub chaw kho mob tus neeg mob cov mob ntshav qab zib hom 2 tam sim no

Hauv tus neeg mob nrog T2DM, uas yav dhau los tswj tau zoo thaum kho nrog Combogliz Prolong® thiab leej twg muaj qhov tsis xws luag hauv lub chaw kuaj lossis tsim muaj kab mob (tshwj xeeb tshaj yog muaj kev paub tsis meej), cov cim ketoacidosis lossis lactic acidosis yuav tsum tau ntsuas tam sim ntawd. Qhov kev ntsuas yuav tsum muaj kev txiav txim siab ntawm cov roj ntsha hauv cov ntshav, ketones, ntshav qabzib thiab, yog tias qhia, ntshav pH, ntau ntawm lactate, pyruvate thiab metformin. Yog tias ib daim ntawv twg ntawm acidosis tau tsim, Kev Tiv Thaiv Combogliz Prolong® yuav tsum tau txiav tawm tam sim ntawd thiab lwm qhov tshuaj tiv thaiv hypoglycemic yuav tsum tau txiav txim.

Kev siv cov tshuaj uas tuaj yeem ua rau txo cov ntshav qab zib

Saxagliptin
Cov tsim tawm ntawm sulfonylureas thiab cov tshuaj insulin tuaj yeem ua rau cov ntshav qab zib tsis txaus.Yog li, txhawm rau txo cov ntshav qog ntshav qab zib thaum siv saxagliptin, yuav tsum txo koob tshuaj sulfonylurea lossis insulin derivatives.
Metformin
Kev mob ntshav qab zib tsis tsim nyob rau hauv cov neeg mob noj cov tshuaj metformin nyob rau hauv txoj kev ib txwm, tab sis tuaj yeem txhim kho nrog cov khoom noj tsis txaus carbohydrate, thaum lub cev ua si tsis yog txhawb los ntawm kev noj zaub mov carbohydrate, lossis nrog concomitant siv nrog lwm cov tshuaj hypoglycemic (xws li sulfonylureas thiab insulin derivatives) lossis cawv. Cov laus, cov tsis muaj zog lossis noj tsis zoo rau cov neeg mob thiab cov neeg mob adrenal lossis pituitary tsis txaus los yog haus dej cawv ntau yog qhov cuam tshuam rau cov teebmeem hypoglycemic. Hauv cov neeg laus thiab cov neeg mob noj cov beta-blockers, kev kuaj mob ntawm cov qog ntshav qab zib tuaj yeem nyuaj.

Mob hnyav pab cuam rau kev ua haujlwm raum lossis faib cov tshuaj metformin

Ceev faj yog qhia kom siv cov tshuaj concomitant (xws li cov tshuaj cationic uas tso tawm los ntawm kev tso tawm hauv lub raum plab), uas tuaj yeem cuam tshuam rau lub raum kev ua haujlwm, ua rau muaj kev hloov pauv hemodynamic lossis cuam tshuam kev faib tawm cov tshuaj metformin (saib Ntu “Kev cuam tshuam nrog lwm cov tshuaj”).

Kev tshawb nrhiav radiological nrog kev tswj hwm intravascular ntawm iodinated sib piv cov neeg sawv cev

Thaum ua kev tshawb nrhiav radiological nrog kev tswj hwm intravascular ntawm iodine-muaj cov tshuaj tiv thaiv kab mob, kev mob raum tsis ua haujlwm tau raug txheeb xyuas, uas tuaj yeem nrog kev txhim kho ntawm cov kab mob lactic acidosis hauv cov neeg mob uas tau txais metformin. Cov neeg mob uas tau teem sijhawm rau kev kawm no yuav tsum tso tseg txoj kev kho Combogliz Prolong® nyob rau hauv 48 teev ua ntej ua txoj kev ua no, tsis txhob noj cov tshuaj nyob rau hauv 48 teev tom qab tau ua tiav, thiab rov pib kho mob tsuas yog tom qab lees tias lub raum tsis ua haujlwm.

Tej yam kev mob hypoxic

Hloov hauv cov ntshav cov piam thaj

Kub taub hau, mob, kab mob, phais yuav tuaj yeem ua rau muaj qhov hloov pauv ntawm cov ntshav qabzib hauv cov ntshav, uas yav dhau los tau tswj hwm los ntawm kev pab los ntawm cov tshuaj Combogliz Prolong®. Hauv cov xwm txheej no, yuav tsum tau tshem tawm kev kho mob ib ntus thiab hloov tus neeg mob mus rau kev kho mob insulin tej zaum yuav tsum tau ua. Tom qab ua kom lub zog nyob hauv kev ua kom cov ntshav qab zib nyob rau hauv cov ntshav thiab txhim kho kev mob ntawm tus neeg mob, kev kho nrog Combogliz Prolong® tuaj yeem rov ua dua.

Kev ua haujlwm tsis haum siab

Thaum lub sijhawm tomqab lawb lag luam siv saxagliptin, muaj qhov tsis haum lub cev tsis haum lub ntsej muag, suav nrog anaphylaxis thiab angioedema. Yog tias qhov kev hloov pauv tsis haum qhov hnyav, koj yuav tsum tso tseg kev siv tshuaj, ntsuas lwm qhov ua rau muaj kev tshwm sim, thiab sau ntawv kho mob ntshav qab zib mellitus kho (saib ntu "Pom Qhov Tsis Zoo" thiab "Sab Cuam").

Kev mob caj dab

Hauv kev tshaj tawm tom qab kev siv saxagliptin, cov lus ceeb toom hais txog qhov tshwm sim ntawm tus mob ntawm tus mob ua paug ncaj qha tau txais. Cov neeg mob uas siv Combogliz Prolong® yuav tsum paub txog cov yam ntxwv ntawm tus mob huam mob vwm: mob ntev, mob heev hauv plab. Yog tias koj xav tias qhov kev txhim kho ntawm pancreatitis, koj yuav tsum tsum tsis txhob noj cov tshuaj Combogliz Prolong® (saib cov ntu "Nrog ceev faj" thiab "Kev phiv tshuaj").
Tus mob ntawm tus mob paj hlwb hauv SAVOR txoj kev tshawb fawb, paub tseeb hais tias raws li txoj kev tshawb no, yog 0.3% nyob hauv saxagliptin thiab cov placebo pawg hauv cov pejxeem ntawm txhua tus neeg mob randomized.

Cov neeg laus cov neeg mob

Ntawm 16492 cov neeg mob randomized hauv SAVOR txoj kev tshawb fawb, 8561 tus neeg mob (51.9%) yog 65 xyoo lossis laus dua, thiab 2330 cov neeg mob (14.1%) yog 75 xyoo lossis laus dua. Ntawm cov no, 4290 cov neeg mob hnub nyoog 65 xyoos thiab laus dua thiab 1169 cov neeg mob hnub nyoog 75 xyoo thiab laus dua tau txais saxagliptin. Raws li kev tshawb fawb hauv kev kho mob, kev ntsuas tau zoo thiab kev nyab xeeb hauv cov neeg mob hnub nyoog 65 xyoos thiab laus dua, 75 xyoo thiab laus dua tsis txawv ntawm cov ntsuas zoo li no hauv cov neeg mob uas muaj hnub nyoog yau dua.

Lub plawv tsis ua hauj lwm

Kev kawm SAVOR tau sau tseg txog kev nce qib hauv tsev kho mob rau lub plawv tsis ua hauj lwm hauv pab pawg saxagliptin piv nrog cov pab pawg placebo, txawm hais tias kev sib raug zoo tsis tseem ceeb. Ceev faj yuav tsum tau siv thaum siv Combogliz Prolong® hauv cov neeg mob uas muaj kev pheej hmoo rau lub plawv tsis ua haujlwm, xws li muaj keeb kwm los ntawm mob raum tsis txaus lossis mob hnyav. Cov neeg mob yuav tsum tau qhia rau cov yam ntxwv ntawm tus yam ntxwv ntawm lub plawv tsis ua hauj lwm thiab yuav tsum tau qhia txog cov tsos mob tam sim ntawd (saib Pharmacodynamics, Chaw Kho Mob Zoo thiab Kev Nyab Xeeb).

Pob Tsuas Xyooj

Cov ntaub ntawv tshaj tawm tom qab tau piav qhia txog kev mob sib koom tes, nrog rau mob hnyav, thaum siv DPP-4 cov tshuaj tiv thaiv kab mob. Hauv cov neeg mob, cov tsos mob nyem tau pom tom qab tsis siv tshuaj, thiab nyob rau hauv tus neeg mob rov qab tshwm sim ntawm cov tsos mob tau pom thaum rov pib siv tib yam lossis lwm qhov DPP-4 inhibitor. Qhov pib ntawm cov tsos mob tom qab pib siv cov tshuaj tuaj yeem nrawm lossis sau tseg tiv thaiv keeb kwm ntawm kev kho mob ntev. Nrog rau kev txhim kho ntawm kev mob pob txha hnyav, qhov tsim nyog ntawm kev txuas ntxiv cov tshuaj hauv txhua tus neeg cov ntaub ntawv yuav tsum raug ntsuas (saib ntu "Sab Cim").

PAUB TXOG KEV RAU TXOJ KEV VAM MEEJ THIAB TSWV YIM UA HAUJ LWM NROG MECHANISMS

Cov kev tshawb fawb ntawm cov nyhuv ntawm saxagliptin ntawm kev muaj peev xwm tsav tsheb thiab kev tswj cov tshuab tseem tsis tau ua. Nco ntsoov tias saxagliptin tuaj yeem ua rau mob taub hau.

Cov Tshuaj Hauv Tshuaj

Combogliz Prolong koom ua ke ob tus kab mob hypoglycemic nrog lub cev sib xyaw ua ke ntawm kev nqis tes ua txhawm rau txhim kho glycemic tswj nyob rau hauv cov neeg mob uas muaj ntshav qab zib hom 2 (hom 2 mob ntshav qab zib mellitus): saxagliptin, ib qho tshuaj tiv thaiv ntawm DPP-4 (dipeptidyl peptidase 4), thiab metformin, uas yog nyob rau hauv chav kawm. lojmuas.

Saxagliptin

Los ntawm cov hnyuv me, hauv kev teb rau kev noj zaub mov, cov tshuaj hormones, incretins, xws li GLP-1 (glucagon-zoo li peptide-1) thiab HIP (glucose-nyob insulinotropic polypeptide) tau tso rau hauv cov ntshav.

Cov tshuaj hormones-incretins txhawb txoj kev tso tawm ntawm insulin los ntawm beta hlwb ntawm cov txiav, uas nyob ntawm qhov kev saib xyuas ntawm cov piam thaj hauv cov ntshav, tab sis lawv nyob rau hauv kev tiv thaiv ob peb feeb los ntawm enzyme DPP-4. Qhov kev nqis tes ntawm GLP-1 kuj tseem ua rau txo qis kev zais ntawm glucagon nyob rau hauv alpha cell ntawm lub txiav, uas ua rau txo qis cov piam thaj hauv kev ua haujlwm hauv lub siab. Qhov siab ntawm GLP-1 hauv cov neeg mob uas muaj ntshav qab zib hom 2 tsawg dua, tab sis cov tshuaj insulin rau GLP-1 tau tshwj tseg. Saxagliptin, yog qhov muaj kev sib tw inhibitor ntawm DPP-4, txo qhov kev tsis muaj zog ntawm cov tshuaj hormones ntau dua, yog li ua rau lawv cov kev xav hauv cov hlab ntshav nce ntxiv, thiab ua rau txo qis cov piam thaj hauv ob lub plab thiab tom qab noj mov.

Metformin yog ib hom tshuaj hypoglycemic uas txhim kho cov kua nplaum nyob hauv cov neeg mob ntshav qab zib hom 2 (los ntawm kev txo qis hauv qab thiab tom qab cov ntshav qabzib ntau).

Cov hauj lwm soj ntsuam ntawm metformin yog los txo qhov tsim tawm ntawm cov piam thaj los ntawm lub siab, ua kom tsis muaj zog ntawm cov piam thaj hauv cov hnyuv, thiab nce insulin rhiab (peripheral nqus thiab siv cov piam thaj nce ntxiv).

Metformin, tsis zoo li sulfonylurea npaj, tsis ua rau hyperinsulinemia thiab ntshav qab zib hauv cov neeg mob ntshav qab zib hom 2 lossis cov neeg noj qab nyob zoo (qhov tshwj tsis yog muaj xwm txheej tshwj xeeb). Kev tso tshuaj ntawm insulin thaum lub sijhawm siv cov tshuaj metformin tsis hloov, txawm hais tias yuav muaj qhov txo qis ntawm cov tshuaj insulin rau ntawm lub plab khoob thiab teb rau ib pluas noj thaum nruab hnub.

ISSUE FORM

1000 zaj duab xis-hloov pauv cov ntsiav tshuaj

7 ntsiav tshuaj rau ib lub raj ntawm txhuas ntawv ci, 4 lossis 8 lub hlwv nrog cov lus qhia

rau kev siv rau hauv thawv ntawv thawv nrog tswj hwm ntawm thawj qhib.

500 mg + 5 mg zaj duab xis-ntsiav tshuaj
7 ntsiav tshuaj rau ib lub raj ntawm txhuas ntawv ci, 4 lub hlwv nrog cov lus qhia rau siv nyob rau hauv lub thawv ntawv thawv nrog tswj cov thawj qhib.

1000 mg + 5 mg zaj duab xis-ntsiav tshuaj
7 ntsiav tshuaj rau ib lub raj ntawm txhuas ntawv ci, 4 lub hlwv nrog cov lus qhia rau siv nyob rau hauv lub thawv ntawv thawv nrog tswj cov thawj qhib.

Nyob rau qhov kub thiab txias tsis tshaj 30 ° C. Khaws tsis ncav cuag ntawm cov menyuam yaus.

TUS KHEEJ, FILLER (THAWJ COV NTAUB NTAWV), PACKER (OB TXHAIS (TUS KHEEJ) TSIM), QHOV KEV TSWJ ZOO

AstraZeneca Tshuaj LP, Tebchaws Asmeskas
4601 Txoj Kev Loj 62 Sab Hnub Tuaj, Mount Vernon, Indiana, 47620, Tebchaws Asmeskas
AstraZeneca Tshuaj LP, Tebchaws Asmeskas
4601 Txoj Kev Loj 62 Sab Hnub Tuaj, Mount Vernon, Indiana, 47620, Tebchaws Asmeskas

Lub npe, chaw nyob ntawm lub koom haum tso cai los ntawm tus tuav lossis tus tswv ntawm daim ntawv sau npe ntawm cov khoom lag luam rau kev kho mob kom lees txais kev thov los ntawm cov neeg siv khoom:

Sawv cev ntawm AstraZeneca UK Limited, UK, hauv Moscow thiab AstraZeneca Cov Tshuaj LLC
125284 Moscow, st. Khiav, 3, p. 1.

Pharmacological cov yam ntxwv ntawm cov tshuaj

Combogliz Prolong yog kev sib xyaw ua ke ntawm saxagliptin thiab metformin, muab cov kws kho mob thiab cov ntshav qab zib nrog lub sijhawm tshiab los tswj lawv cov glycemic profile.

Combogliz Prolong: cov lus qhia rau kev siv

Tus kws kho mob xaiv cov sij hawm ntawm kev tswj hwm thiab noj ntau npaum li cas, noj mus rau hauv tus lej ntsuas ntawm glucometer, kev noj qab haus huv thoob plaws, hnub nyoog ntawm cov ntshav qab zib, cov tshuaj tiv thaiv ib leeg rau cov ntsiav tshuaj. Feem ntau, cov kev qhia muab cov lus qhia zoo li no.

Ib lub sij hawm ntev tshuaj feem ntau noj 1 r. / Hnub. tib lub sijhawm.

Haus ib ntsiav tshuaj thaum sawv ntxov lossis yav tsaus ntuj, tsis muaj kev sib tsoo. Rau cov khoos phis tawm cov qauv tsim tawm, lub plhaub kev ncaj ncees ua lub luag haujlwm tshwj xeeb.

Qhov ntau npaum li cas yog ib tug neeg, raws li kev pib kho mob nws tuaj yeem yog 1 ntsiav tshuaj (500 mg ntawm metformin + 2.5 mg ntawm saxagliptin), yog tias ua tiav glycemic tswj tsis tuaj yeem ua tiav, qhov koob tshuaj tau nce rau 2 ntsiav tshuaj (1000 mg ntawm metformin + 5 mg ntawm saxagliptin).

Nrog rau kev siv tshuaj ib txhij rau kev kho mob ntawm cov kab mob uas pom tseeb, cov txiaj ntsig ntawm lawv cov kev cuam tshuam yuav tsum ua tib zoo xav txog. Hauv tshwj xeeb, nrog kev tswj hwm tib lub sijhawm ntawm cov tshuaj tiv thaiv kab mob CYP3A4 / 5 isoenzymes (Indinavir, Ketoconazole, Nefazodon, Itraconazole, Atazanavir), koob tshuaj tsawg kawg ntawm saxagliptin yog tshuaj - 2.5 mg.

Tshuaj Metformin nrog rau qhov ua kom ntev ntev ntawm qhov tshwm sim tsis zoo hauv daim ntawv ntawm kev ua rau mob dyspeptic tsis tshua muaj ntau npaum li cov tshuaj analogues nrog kev tso tawm sai. Yog li tias lub cev yoog rau cov kev mob tshiab, nws yog qhov tsis mob kiag li rau txoj hnyuv, koob tshuaj titration yuav tsum tau nqa tawm maj, txhua 2 lub lis piam.

Txhua yam kev hloov pauv hauv lub neej yuav tsum raug suav nrog thaum kho qhov kev cai noj tshuaj, yog li nws yog qhov tseem ceeb uas yuav tsum tau qhia tus kws kho mob txog lawv lub sijhawm.

Cov Lus Cim Kombiglyce Prolong

Rau Combogliz Prolong, ib qho analogue nrog cov qub ntawm cov khoom xyaw nquag yuav yog Comboglis XR, uas yog tsim hauv Ltalis thiab UK. Tus nqi ntawm ib qho analogue yog los ntawm 1650 rubles. (28 ntsiav tshuaj ntawm 1000 mg ntawm metformin thiab 2.5 mg ntawm saxagliptin).

Cov tshuaj sib xyaw ua ke ntawm Avandamet, Yanumet, Glimecomb, GalvusMet thiab Bagomet ntxiv muaj cov kev ua kom zoo nkauj zoo sib xws.

Qhia tshuaj rau cov tshuaj raws li ib yam muaj txiaj ntsig xws li Glyformin Prolong, Glucofage, Metadiene, Sofamet, Diaformin Od, Ongliza, Matospanin, Metfogamma, Siofora.

Leej twg muaj tshuaj

Combogliz prolong tau tawm rau hom 2 mob ntshav qab zib kom normalize glycemic tswj ntxiv rau kev noj haus kom tsawg thiab ua kom lub cev muaj zog txaus, yog tias txoj kev ua neej nyob tsis muab cov txiaj ntsig uas xav tau thiab kev sib xyaw ntawm saxagliptin nrog metformin yog qhov tsim nyog rau tus neeg mob.

Kev tsis raug thiab tus txheeb ze contraindications

Txawm hais tias cov tshuaj noj nrog qhov siab ntawm kev nyab xeeb, uas yog Combogliz Prolong, tsis yog rau kev siv tshuaj rau ib leeg rau ib leeg thiab kev mob siab rau qhov sib xyaw ntawm cov mis.

Cov tshuaj tsis yog pom rau cov niam cev xeeb tub thiab lactating (lawv tau pauv mus rau ib ntus rau insulin), vim tias tsis muaj pov thawj txaus rau nws cov hauj lwm zoo, nws tsis yog kws kho rau menyuam yaus.
Cov tshuaj tsis haum rau cov neeg mob ntshav qab zib muaj 1 hom mob.
Hauv kev ua haujlwm ntawm lub raum, nrog rau cov xwm txheej uas ua rau lawv mob, cov tshuaj kuj tsis raug txwv.
Tsis txhob siv cov tshuaj kho mob rau cov neeg mob pathologies uas ua rau oxygen oxygen tshaib plab ntawm cov ntaub so ntswg.
Nrog ketoacidosis (ib daim ntawv uas mob ntshav qab zib) nrog lossis tsis nco qab, cov tshuaj yog tsis noj ib ntus.
Cov tshuaj tua kab mob raug tso tseg thaum ua haujlwm, nrog raug mob hnyav, kub nyhiab. Kev ntsuam xyuas xoo hluav taws xob nrog cov cim iodine uas muaj cov cim ntsuas hauv ntshav qab zib yuav ua rau lub raum puas tsuaj, yog li nws kuj hloov mus rau cov tshuaj insulin. Hauv tag nrho, kev kho mob insulin yog qhia rau 48 teev ua ntej thiab 48 teev tom qab cov txheej txheem, tshwj xeeb, nws txhua tus yog nyob ntawm qhov mob ntawm ob lub raum thiab kev noj qab nyob zoo ntawm tus neeg mob.
Lub siab pathologies, lactic acidosis thiab cawv quav cawv kuj yog nyob rau hauv daim ntawv teev npe ntawm contraindications. Koj tsis tuaj yeem hais kom yuav cov tshuaj rau cov neeg mob uas mob caj ces galactose intolerance.

Kev saib xyuas tshwj xeeb yuav tsum tau them rau cov mob ntshav qab zib ntawm lub hnub nyoog laus, tshwj xeeb tshaj yog nrog kev noj zaub mov tsis txaus, mob rau leeg thiab tsis ua haujlwm txaus hauv lub cev uas tuaj yeem ua rau mob ntshav qab zib.

Muaj peev xwm tsis xav txog kev cuam tshuam thiab overdose

Saxagliptin nrog kev sib txawv ntawm qhov tshwm sim muaj peev xwm ua rau muaj mob:

Kev mob pob txha
Mob plab zom mov
O rau lub ntsej muag,
Kev mob caj dab
Urticaria.

Kev tshawb pom hauv lub chaw sim pom tau txo qis ntawm qhov nqus tau cov vitamin B12 nrog rau kev siv lub sijhawm ntev ntawm cov tshuaj, nrog rau kev txo qis ntawm cov lymphocytes. Cov mob ntawm kev noj ntau tshaj yog ib leeg, ntau zaus tshwm sim nrog kev siv saxagliptin ntev ntev. Cov tshuaj tsis ua rau qaug cawv, nrog ib qho dhau ntawm cov tshuaj, hemodialysis zoo. Nyob rau hauv parallel, kev tshwm sim kev kho mob yog ua.

Kev noj tshuaj ntau tshaj plaws ntawm metformin yog qhov ntau, qhov txaus ntshai tshaj plaws yog lactic acidosis.Cov. Koj tuaj yeem paub tus mob los ntawm cov cim hauv qab no:

Rawg
Txog siav
Mob plab
Cov ntshav siab qis
Kev Ntshav Qab Zib,
Mob leeg
Lub plawv tuaj kev ntxhov siab.

Nyob rau hauv qhov teeb meem nyuaj, hnov tsis nco qab, tsaus muag, hnov ntsej muag thiab coma tshwm sim. Tus neeg raug tsim txom xav tau kev mus pw hauv tsev kho mob sai, yam tsis muaj kev kho mob txaus, nws tuaj yeem tuag. Kev siv ntau tshaj metformin tseem raug tshem tawm los ntawm hemodialysis, nws yog ib qho tseem ceeb uas yuav tsum xav txog tias kev tshem tawm creatinine ncav cuag 170 ml / min.

Qhov ntau dua raws li cov ntshav qab zib ua tau raws li txhua tus kws kho mob pom zoo, qhov tsawg dua kev pheej hmoo ntawm kev mob nyhav. Xws li Combogliz ntev heev, nws tsis yog qhov nyuaj ua raws li daim ntawv qhia noj tshuaj.

Cov kev xaiv rau kev sib tham nrog lwm cov tshuaj

Thaum txhim kho txoj kev kho mob nrog Combogliz Prolong, nws yog ib qho tseem ceeb kom ceeb toom tus kws endocrinologist txog txhua yam tshuaj uas tus mob ntshav qab zib siv los kho cov kab mob concomitant. Ib txhia ntawm lawv muaj peev xwm txhim kho cov suab thaj-txo cov peev xwm ntawm Comboglize, lwm tus txwv nws txoj haujlwm.

Rau lub tswv yim dav dav, koj tuaj yeem tshawb lub rooj.

Cov nyhuv hyperglycemic ntxiv

Rifampicin, Pioglitazone, Magnesium thiab Aluminium Hydroxides / SimethiconeGCS, diuretics, nicotinic acid

cov thyroid hormones, isoniazid, sympathomimetics, phenothiazines, estrogens, phenytoin, calcium channel blockers

Provoke hypoglycemic tej yam kev mob

Amprenavir, Diltiazem, Erythromycin, Fluconazole, Aprepitant, Verapamil, txiv kab ntxwv qaub, Ketoconazole, sulfonylurea tshuaj, Glibenclamide, Ketoconazole, CYP3A 4/5 isoenzymes, FamotidineCov tshuaj Cationic, Furosemide, tshuaj xws li ethanol, Nifedipine

Amprenavir, Diltiazem, Erythromycin, Fluconazole, Aprepitant, Verapamil, txiv kab ntxwv qaub, Ketoconazole, sulfonylurea tshuaj, Glibenclamide, Ketoconazole, CYP3A 4/5 isoenzymes, Famotidine
Cov tshuaj Cationic, Furosemide, tshuaj xws li ethanol, Nifedipine

Nws pom tseeb tias kev sim tshuaj ntsuas tus kheej thiab kev noj tshuaj rau tus kheej nrog Combogliz Prolong tuaj yeem muaj kev phom sij loj rau kev noj qab haus huv.

Combogliz Prolong: txheeb xyuas cov ntshav qab zib

Cov kws kho mob soj ntsuam qhov ua tau zoo ntawm kev kho mob nrog Combogliz Prolong tshuaj nco ntsoov nws qhov kev tsis sib xws, thiab tus kab mob ntshav qab zib kuj tsis muaj kev ntseeg nyob hauv nws lub peev xwm.

Ua kom tiav cov kev tswj ntshav qab zib yuav tsum muaj kev sib koom ua ke: tsawg-carb fractional khoom noj khoom haus, tshuaj xyuas txhua hnub ntawm glucometer nyeem ntawv, kev tawm dag zog kom lub cev thiab kev txhawb nqa tshuaj. Tsuas yog hauv qhov kev sib xyaw ua ke no peb tuaj yeem suav rau qhov 100% nyhuv ntawm Combogliz Prolong.

Hauv daim yeeb yaj kiab, tus kws tshaj lij-endocrinologist A.S. Ametov tham txog cov qauv tshiab ntawm kev tswj hwm tus mob ntshav qab zib hom 2.

Cov Tshuaj Pharmacokinetics

Bioequivalence thiab qhov cuam tshuam ntawm cov zaub mov ntawm kev sib xyaw ntawm cov tshuaj lom neeg sib xyaw ua ke ntawm Comboglize Prolong tau pom los ntawm cov neeg mob ua raws cov zaub mov uas tsis muaj calorie tsawg, uas muab 324 kcal nrog cov khoom noj muaj txiaj ntsig thiab muaj: cov protein - 11.1%, rog - 10.5%, carbohydrates - 78,4%. Raws li cov khoom noj khoom haus no, nyob rau hauv cov kev noj qab haus huv, raws li kev tshawb fawb, cov kev sib raug zoo ntawm lub khw muag tshuaj ntawm kev sib xyaw ntawm metformin + saxagliptin hauv cov ntsiav tshuaj thiab cov ntsiav tshuaj ntawm kev hloov pauv ntawm saxagliptin thiab metformin hauv cov koob tshuaj zoo ib yam tau pom.

Cov xwm txheej tshwj xeeb

Kev siv ntawm Combogliz Prolong nrog lub raum ua haujlwm tsis zoo thiab ua rau lub siab ua haujlwm tsis zoo yog tsis pom zoo.

Cov neeg mob hnub nyoog 65-80 xyoo tsis tau qhia pom qhov sib txawv hauv khw muag tshuaj sib txawv ntawm saxagliptin piv nrog cov neeg mob uas muaj hnub nyoog yau dua (18-40 xyoo), yog li ntawd yuav tau kho cov tshuaj rau cov neeg laus laus tsis tas yuav tsum. Txawm li cas los xij, nws yuav tsum raug coj mus rau hauv kev txiav txim siab tias hauv pawg no ntawm cov neeg mob, qhov kev txo qis ntawm lub raum ua tau ntau dua. Thaum muaj hnub nyoog li cas, tsis tas yuav sau tshuaj Combogliz Prolong kom txog thaum tsis ua haujlwm ntawm lub raum.

Cov neeg mob uas muaj hnub nyoog 80 xyoo yog pom tseeb hauv kev siv tshuaj, tshwj tsis yog lub raum ua haujlwm ib txwm muaj kev paub tseeb los ntawm kev ntsuas ntawm creatinine tshem.

Cov kev tshawb fawb ntawm pharmacokinetics ntawm cov tshuaj yeeb tshuaj Comboglyz Prolong hauv cov menyuam yaus tsis tau ua.

Kev phiv tshuaj rau saxagliptin kaw hauv SAVOR txoj kev tshawb no

Qhov feem ntawm cov neeg mob uas tau tsim muaj ntshav qab zib tsawg thaum lub sijhawm kho (hypoglycemia, uas yuav tsum tau kev pab ntawm pawg neeg thib peb) tau siab dua hauv saxagliptin pawg piv rau cov pab pawg placebo.

Ib qho kev pheej hmoo ntawm kev muaj ntshav qab zib tsawg feem ntau, nrog rau kev mob ntshav qab zib ntau hauv saxagliptin pawg, feem ntau pom nyob hauv cov neeg mob uas tau txais sulfonylurea kev npaj, tab sis tsis yog rau cov neeg mob uas tau txais tshuaj metformin lossis insulin raws li kev kho mob tseem ceeb.

Nyob rau hauv tag nrho, ib qho kev pheej hmoo ntawm hypoglycemia, nrog rau kev mob ntshav qab zib ntshav ntau, tau sau tseg feem ntau yog rau cov neeg mob uas muaj lub hauv paus glycated hemoglobin (HbAlc) tsawg dua 7%.

Tom qab muag kev thov

Thaum soj ntsuam tom qab kev muag khoom, kev txhim kho cov kev mob tshwm sim hauv qab no tau sau cia: mob nrawm, mob ua kom tsis haum ntshav (suav nrog anaphylaxis, angioedema, xoo pob thiab urticaria) thiab mob caj dab. Nws yog kev ntseeg tau tsis yooj yim sua suab los ntsuas cov zaus ntawm kev loj hlob ntawm cov tshwm sim no.

Nrog rau kev siv saxagliptin, ib koob tshuaj qhov nruab nrab txo qis hauv tus naj npawb ntawm lymphocytes tau sau tseg.Feem ntau, nrog kev siv saxagliptin ntau zaus, tsis muaj qhov rov huam mob tau pom, txawm hais tias nyob hauv qee tus neeg mob cov lymphocytes tsawg dua tom qab rov pib kho nrog saxagliptin, uas ua rau tsis siv tshuaj yeeb. Qhov kev txo qis ntawm cov lymphocytes tsis yog nrog cov kev sim hauv lub chaw kuaj mob. Cov laj thawj ntawm qhov kev ua txhaum tsis paub. Thaum muaj mob ntev lossis txawv txav, koj yuav tsum ntsuas cov lymphocytes ntau npaum li cas. Cov nyhuv ntawm saxagliptin ntawm cov lymphocytes hauv cov neeg mob uas muaj qhov txawv txav hauv lawv tus lej (suav nrog tib neeg cov tshuaj tiv thaiv kab mob) tsis paub.

Hauv cov kev tshawb fawb soj ntsuam ntawm metformin, kwv yees li 7% ntawm cov neeg mob tau pom tias muaj ntau cov vitamin B ntau zuj zus₁₂ (tsis muaj yav dhau los) rau qhov tsis muaj nuj nqis uas tsis nrog kev sim los saib xyuas. Ntxiv mus, xws li qhov txo qis hauv kev txhim kho ntawm tus neeg mob ntshav nrog nrog tsis tshua muaj, tom qab tshem tawm ntawm cov tshuaj metformin lossis kev noj cov tshuaj vitamin B ntxiv.₁₂ zoo tu qab sai.

Nrog lub raum tsis ua haujlwm

Cov Txheej Txheem Los Siv Siv Comboglize Ntev los ntawm ib sab ntawm lub raum muaj nuj nqi:

lub raum tsis ua hauj lwm (cov ntshav liab creatinine: txiv neej ≥ 1.5 mg / dl, poj niam ≥1.4 mg / dl lossis txo creatinine tshem tawm), suav nrog cov mob septicemia, mob myocardial infarction, mob plawv tsis txaus (poob siab) ,
mob kab mob siab, uas yog qhov muaj pheej hmoo ua tsis tiav lub raum kev ua haujlwm.