Galvus yog tshuaj rau ntshav qab zib, cov tshuaj nquag ntawm uas yog vildagliptin, los ntawm cov pab pawg ntawm DPP-4 inhibitors. Cov ntsiav tshuaj ntshav qab zib Galvus tau sau npe nyob rau hauv Russia txij li xyoo 2009. Lawv tau tsim los ntawm Novartis Pharma (Switzerland).
Galvus ntsiav tshuaj rau cov ntshav qab zib los ntawm pab pawg ntawm inhibitors ntawm DPP-4 - cov tshuaj nquag Vildagliptin
Galvus tau sau npe rau kev kho mob ntawm cov neeg mob ntshav qab zib hom 2. Nws tuaj yeem siv los ua cov tshuaj nkaus xwb, thiab nws cov nyhuv yuav ua tiav cov txiaj ntsig ntawm kev noj haus thiab kev tawm dag zog. Galvus tshuaj kho ntshav qab zib kuj tseem siv tau ua ke nrog:
- metformin (siofor, glucophage);
- sulfonylurea derivatives (tsis txhob ua qhov no!);
- thiazolinediones;
- tshuaj insulin
Daim ntawv tso tawm
Daim ntawv kws tshuaj Galvus (vildagliptin) - 50 mg ntsiav tshuaj.
Galvus ntsiav tshuaj ntau npaum
Tus txheej txheem koob tshuaj Galvus raws li kev kho mob monotherapy lossis hauv kev sib xyaw nrog metformin, thiazolinediones lossis insulin - 2 zaug hauv ib hnub, 50 mg, sawv ntxov thiab yav tsaus ntuj, tsis hais noj zaub mov noj. Yog tias tus neeg mob tau sau ntawv rau 1 koob tshuaj 50 mg rau ib hnub, tom qab ntawv yuav tsum noj thaum sawv ntxov.
Vildagliptin - cov tshuaj nquag ntawm cov tshuaj rau ntshav qab zib Galvus - raug tawm los ntawm lub raum, tab sis ua rau lub cev tsis muaj zog. Yog li no, thaum pib ntawm lub raum tsis ua haujlwm, qhov ntau npaum ntawm cov tshuaj tsis tas yuav hloov pauv.
Yog tias muaj kev ua txhaum loj ntawm daim siab ua haujlwm (ALT lossis AST cov ntshav ntev li 2,5 zaug siab dua li qhov siab dua qhov ib txwm muaj), tom qab ntawd Galvus yuav tsum tau txiav txim siab nrog kev ceev faj. Yog tias tus neeg mob lub ntsej muag daj ntseg lossis lwm yam kev mob siab hauv lub siab tshwm sim, kev kho mob vildagliptin yuav tsum nres tam sim ntawd.
Rau cov ntshav qab zib hnub nyoog 65 xyoo thiab laus dua - qhov koob tshuaj Galvus tsis hloov pauv yog tias tsis muaj kab mob concomitant. Tsis muaj ntaub ntawv qhia txog kev siv tshuaj kho mob ntshav qab zib no hauv menyuam yaus thiab cov tub ntxhais hluas hnub nyoog qis dua 18 xyoo. Yog li, nws tsis pom zoo kom muab nws rau cov neeg mob ntawm pawg hnub nyoog no.
Qab zib-txo cov nyhuv ntawm vildagliptin
Cov suab thaj txo cov nyhuv ntawm vildagliptin tau kawm nyob rau hauv pab pawg ntawm 354 tus neeg mob. Nws tau muab tawm tias galvus monotherapy ua ntej 24 lub lis piam ua rau txo qis cov ntshav qabzib hauv cov neeg mob uas tsis tau ua yav tas los kho lawv hom ntshav qab zib 2. Lawv glycated hemoglobin Performance index poob qis 0.4-0.8%, thiab hauv pawg placebo - los ntawm 0.1%.
Lwm qhov kev tshawb fawb piv cov kev cuam tshuam ntawm vildagliptin thiab metformin, cov tshuaj mob ntshav qab zib uas nrov tshaj plaws (siofor, glucophage). Txoj kev tshawb fawb no tseem koom nrog cov neeg mob uas nyuam qhuav mob ntshav qab zib hom 2, thiab tsis tau raug kho ua ntej.
Nws muab tawm tias galvus hauv ntau qhov ntsuas kev ua tau zoo tsis qis dua rau metformin. Tom qab 52 lub lis piam (kev kho mob 1 xyoo) hauv cov neeg mob noj galvus, qib ntawm glycated hemoglobin poob qis los ntawm qhov nruab nrab ntawm 1.0%. Hauv pawg metformin, nws txo qis los ntawm 1.4%. Tom qab 2 xyoos, cov lej tseem nyob tib yam.
Tom qab 52 lub lim tiam ntawm kev noj cov ntsiav tshuaj, nws muab tawm tias qhov kev hloov pauv ntawm lub cev hnyav hauv cov neeg mob hauv cov pab pawg ntawm vildagliptin thiab metformin yuav luag zoo li qub.
Galvus zam tau zoo los ntawm cov neeg mob dua li metformin (Siofor). Phiv los ntawm cov hnyuv huam sai sai ntau muaj tsawg. Yog li no, niaj hnub pom zoo tso cai Lavxias algorithms rau kev kho mob hom 2 ntshav qab zib tso cai rau koj pib kev kho mob nrog galvus, nrog rau metformin.
Galvus Met: vildagliptin + kev sib xyaw metformin
Galvus Met yog cov tshuaj sib xyaw, 1 ntsiav tshuaj ntawm muaj vildagliptin ntawm koob tshuaj 50 mg thiab metformin ntawm koob tshuaj 500, 850 lossis 1000 mg. Sau npe nyob Xos Viav thaum Lub Peb Hlis 2009. Nws raug nquahu kom noj tshuaj rau cov neeg mob 1 ntsiav tshuaj 2 zaug ib hnub.
Galvus Met yog cov tshuaj sib xyaw rau hom 2 ntshav qab zib. Nws muaj vildagliptin thiab metformin. Ob qho khoom xyaw nquag hauv ib ntsiav tshuaj - yooj yim siv thiab ua tau zoo.
Kev sib xyaw ua ke ntawm vildagliptin thiab metformin raug lees paub tias tsim nyog rau kev kho mob ntshav qab zib hom 2 hauv cov neeg mob uas tsis siv tshuaj metformin ib leeg. Nws qhov zoo:
- cov nyhuv ntawm kev txo qis ntshav qabzib cov ntshav nce ntxiv, piv nrog monotherapy nrog ib qho ntawm cov tshuaj;
- qhov seem ua haujlwm ntawm cov qe hlwb hauv kev tsim cov tshuaj insulin yog khaws cia;
- lub cev nyhav hauv cov neeg mob tsis nce ntxiv;
- txoj kev pheej hmoo ntawm hypoglycemia, nrog rau mob hnyav, tsis nce;
- qhov nquag ntawm cov kev mob tshwm sim ntawm metformin los ntawm kev mob plab zom mov - tseem nyob rau tib theem, tsis nce ntxiv.
Cov kev tshawb fawb tau ua pov thawj tias kev noj Galvus Met ua tau zoo dua li siv ob lub tshuaj sib txawv nrog metformin thiab vildagliptin. Tab sis yog tias koj xav noj ib ntsiav tshuaj xwb, ces nws yooj yim dua thiab kev kho mob kom zoo dua qub. Vim tias nws tsis tshua zoo siab uas tus neeg mob yuav hnov qab lossis cuam tshuam ib yam dab tsi.
Ua qhov kev tshawb nrhiav - piv rau kev kho mob ntshav qab zib nrog Galvus Met nrog lwm cov qauv sib txawv: metformin + sulfonylureas. Sulfonylureas tau raug samfwm rau cov neeg mob ntshav qab zib uas pom Metformin ib leeg tsis txaus.
Txoj kev tshawb no tau teev npe. Ntau tshaj 1300 tus neeg mob hauv ob pawg neeg tau koom nrog nws. Ntev - 1 xyoos. Nws tau muab tawm tias nyob rau hauv cov neeg mob noj vildagliptin (50 mg 2 zaug hauv ib hnub) nrog metformin, cov ntshav qabzib cov ntshav qis tsawg dua li cov neeg noj glimepiride (6 mg 1 zaug hauv ib hnub).
Nws tsis muaj qhov sib txawv ntawm qhov tshwm sim rau kev txo cov ntshav qab zib. Nyob rau tib lub sijhawm, cov neeg mob hauv Galvus Met tshuaj pab pawg tau ntsib kev mob ntshav qab zib tsawg dua 10 zaug tsawg dua li cov uas tau kho nrog glimepiride nrog metformin. Tsis muaj cov neeg mob ntshav qab zib ntau hauv cov neeg mob noj Galvus Met rau lub xyoo tag nrho.
Tshuaj Ntshav Qab Zib Galvus Tau Siv Ua Li Cas Nrog Insulin
Galvus yog thawj cov tshuaj kho ntshav qab zib hauv DPP-4 inhibitor pawg, uas tau sau npe rau kev siv tshuaj nrog cov tshuaj insulin. Raws li txoj cai, nws yog tshuaj yog tias nws tsis tuaj yeem tswj hwm tus mob ntshav qab zib hom 2 zoo nrog kev kho mob ib leeg, uas yog "insulin" ntev ntev.
Ib txoj kev tshawb nrhiav xyoo 2007 tau txheeb xyuas kev ua tau zoo thiab kev nyab xeeb ntawm kev ntxiv galvus (50 mg 2 zaug hauv ib hnub) tiv thaiv cov placebo. Cov neeg mob koom nrog qhov tseem nyob ntawm theem ntawm glycated hemoglobin (7.5-11%) tiv thaiv kev txhaj tshuaj ntawm "nruab nrab" insulin nrog nruab nrab Hagedorn protramine (NPH) ntawm kev siv ntau dua 30 units / hnub.
144 cov neeg mob tau txais galvus nrog rau cov tshuaj insulin, 152 cov neeg mob ntshav qab zib hom 2 tau txais cov placebo nyob rau tom qab ntawm cov tshuaj insulin. Hauv pawg vildagliptin, qhov nruab nrab ntawm glycated hemoglobin ho nqis txog 0.5%. Hauv pawg placebo, los ntawm 0.2%. Hauv cov neeg mob uas laus dua 65 xyoo, qhov ntsuas tseem zoo dua - txo qis 0.7% ntawm keeb kwm ntawm galvus thiab 0.1% vim yog noj tshuaj placebo.
Tom qab ntxiv galvus rau insulin, txoj kev pheej hmoo ntawm hypoglycemia poob qis, piv nrog kev kho mob ntshav qab zib, tsuas yog txhaj "nruab nrab" NPH-insulin. Hauv cov pab pawg vildagliptin, tag nrho pes tsawg tus neeg ntawm kev mob ntshav qab zib yog 113, hauv pawg placebo - 185. Ntxiv mus, tsis muaj ib kis los ntawm kev mob ntshav siab hnyav tsawg tau sau tseg tiv thaiv keeb kwm ntawm kev kho mob vildagliptin. Muaj 6 qhov xwm txheej zoo li no hauv pawg pab pawg.
Sab sij huam
Feem ntau, galvus yog cov tshuaj siv tau nyab xeeb heev. Cov kev tshawb fawb pom tseeb tias kev kho mob rau cov ntshav qab zib hom 2 nrog cov tshuaj no tsis ua rau muaj kev pheej hmoo ntawm cov kab mob plawv, mob siab, lossis lub cev tsis muaj zog. Noj cov tshuaj vildagliptin (cov tshuaj ua kom nquag plias hauv galvus ntsiav tshuaj) tsis nce qhov hnyav hauv lub cev.
Muab piv nrog cov tshuaj ua kom ntshav qabzib cov tshuaj tiv thaiv qis, nrog rau cov placebo, galvus tsis muaj kev pheej hmoo rau ntawm pancreatitis. Feem ntau ntawm nws cov kev mob tshwm sim yog mob me me thiab ib ntus. Tsis tshua pom muaj:
- lub siab ua tsis taus haujlwm (suav nrog kab mob siab);
- angioedema.
Qhov xwm txheej ntawm cov kev mob tshwm sim no yog los ntawm 1/1000 txog rau 1/10 000 tus neeg mob.
Galvus tshuaj kho ntshav qab zib: contraindications
Contraindications rau kev teem caij ntsiav tshuaj los ntawm ntshav qab zib Galvus:
- yam 1 mob ntshav qab zib mellitus;
- cev xeeb tub thiab lactation;
- mob ketoacidosis;
- ua kom lub cev tsis haum rau cov tshuaj ntawm cov tshuaj.
