Galvus ndi mankhwala a matenda ashuga, omwe amagwira ntchito ndi vildagliptin, ochokera ku gulu la DPP-4 zoletsa. Mapiritsi a shuga a Galvus adalembedwa ku Russia kuyambira 2009. Amapangidwa ndi Novartis Pharma (Switzerland).
Mapiritsi a Galvus a shuga kuchokera ku gulu la zoletsa za DPP-4 - yogwira mankhwala Vildagliptin
Galvus adalembedwa kuti athandize odwala omwe ali ndi matenda ashuga a 2. Itha kugwiritsidwa ntchito ngati mankhwala okhawo, ndipo zotsatira zake zimakwaniritsa zotsatira za zakudya komanso masewera olimbitsa thupi. Mapiritsi a shuga a Galvus akhoza kugwiritsidwanso ntchito limodzi:
- metformin (siofor, glucophage);
- zotumphukira za sulfonylurea (musachite izi!);
- thiazolinediones;
- insulin
Kutulutsa Fomu
Mawonekedwe a mankhwala Galvus (vildagliptin) - mapiritsi a 50 mg.
Mlingo wa mapiritsi a Galvus
Mlingo wofanana ndi wa Galvus monga monotherapy kapena molumikizana ndi metformin, thiazolinediones kapena insulin - 2 pa tsiku, 50 mg, m'mawa ndi madzulo, mosasamala kanthu za kudya. Ngati wodwala amupatsa mlingo wa piritsi 1 la 50 mg patsiku, ndiye kuti ayenera kumwedwa.
Vildagliptin - zomwe zimagwiritsidwa ntchito ngati mankhwala a matenda a shuga Galvus - zimapukusidwa ndi impso, koma mawonekedwe a metabolites osagwira. Chifukwa chake, pakuyamba kwa kulephera kwa impso, mlingo wa mankhwalawa suyenera kusinthidwa.
Ngati pali kuphwanya kwamphamvu kwa chiwindi ntchito (ALT kapena AST michere pafupipafupi 2.5 kuposa malire apamwamba), ndiye kuti Galvus iyenera kuyikidwa mosamala. Wodwala akayamba jaundice kapena zodandaula zina za chiwindi zimawonekera, chithandizo cha vildagliptin chiyenera kuyimitsidwa nthawi yomweyo.
Kwa odwala matenda ashuga azaka 65 ndi kupitilira - muyeso wa Galvus sukusintha ngati kulibe matenda ophatikizika. Palibe chidziwitso pakugwiritsa ntchito mankhwalawa kwa ana ndi achinyamata ochepera zaka 18. Chifukwa chake, sikulimbikitsidwa kuti mupereke kwa odwala a m'badwo uno.
Kuchepetsa shuga kwa vildagliptin
Mphamvu yotsitsa shuga ya vildagliptin idaphunzira pagulu la odwala 354. Zinapezeka kuti galvus monotherapy mkati mwa masabata 24 zinapangitsa kutsika kwakukulu kwa shuga m'magazi omwe sanalandire mtundu wawo wa 2 shuga. Mndandanda wawo wa hemoglobin wa glycated watsika ndi 0.4-0.8%, ndipo pagulu la placebo - ndi 0,1%.
Kafukufuku wina anayerekezera zotsatira za vildagliptin ndi metformin, mankhwala odziwika bwino a shuga (siofor, glucophage). Kafukufukuyu adakhudzanso odwala omwe adapezeka atapezeka ndi matenda ashuga a 2, omwe anali asadalandiridwepo kale.
Zidadziwika kuti galvus muzowonetsa zambiri zogwiririra ntchito siyotsika ndi metformin. Pambuyo pa masabata 52 (chaka chimodzi cha chithandizo) mwa odwala omwe akutenga galvus, kuchuluka kwa hemoglobin ya glycated kunatsika ndi pafupifupi 1.0%. Mu gulu la metformin, adatsika ndi 1.4%. Pambuyo pa zaka ziwiri, manambala adakhalabe omwewo.
Pambuyo pa masabata 52 atamwa mapiritsiwo, zidapezeka kuti mphamvu zamagetsi owonda m'thupi la odwala omwe ali m'magulu a vildagliptin ndi metformin ali ofanana.
Galvus imalekeredwa bwino ndi odwala kuposa metformin (Siofor). Zotsatira zoyipa zam'mimba zimayambira pafupipafupi. Chifukwa chake, ma algorithms amakono omwe akuvomerezedwa ndi Russia pakuchiza matenda amtundu wa 2 amakulolani kuti muyambe kulandira chithandizo ndi galvus, pamodzi ndi metformin.
Galvus Met: vildagliptin + kuphatikiza kwa metformin
Galvus Met ndi mankhwala ophatikiza, piritsi limodzi lokhala ndi vildagliptin pa 50 mg ndi metformin pa Mlingo wa 500, 850 kapena 1000 mg. Kulembetsa ku Russia mu Marichi 2009. Ndi bwino kulembera odwala piritsi 1 kawiri pa tsiku.
Galvus Met ndi mankhwala ophatikiza matenda a shuga a 2. Muli vildagliptin ndi metformin. Zosakaniza ziwiri zogwira ntchito piritsi limodzi - zosavuta kugwiritsa ntchito komanso zothandiza.
Kuphatikizidwa kwa vildagliptin ndi metformin kumadziwika kuti ndizoyenera kuchiza matenda amtundu wa 2 odwala omwe samamwa metformin okha. Ubwino wake:
- mphamvu yochepetsera shuga wamagazi imachulukitsidwa, poyerekeza ndi monotherapy ndi mankhwala aliwonse;
- ntchito yotsalira ya maselo a beta pakupanga insulin imasungidwa;
- kuchuluka kwa thupi mwa odwala sikuwonjezeka;
- chiopsezo cha hypoglycemia, kuphatikizapo choopsa, sichikuchuluka;
- pafupipafupi zotsatira zoyipa za metformin kuchokera m'matumbo am'mimba - zimakhalabe chimodzimodzi, sizikukula.
Kafukufuku watsimikizira kuti kutenga Galvus Met ndikothandiza kwambiri ngati mutenga mapiritsi awiri osiyana ndi metformin ndi vildagliptin. Koma ngati mukufuna kumwa piritsi limodzi lokha, ndiye kuti ndi losavuta kwambiri ndipo mankhwalawo ndi othandiza kwambiri. Chifukwa sizochepa kuti wodwalayo aiwale kapena kusokoneza china chake.
Wachita kafukufuku - ndikufanizira chithandizo cha matenda ashuga ndi Galvus Met ndi chiwembu china chodziwika bwino: metformin + sulfonylureas. Sulfonylureas adalembedwa kwa odwala matenda a shuga omwe adapeza kuti Metformin yekha ndiwosakwanira.
Phunziroli linali lalikulu. Oposa 1300 odwala m'magulu onse awiri adatenga nawo mbali. Kutalika - 1 chaka. Zinapezeka kuti odwala omwe akutenga vildagliptin (50 mg 2 kawiri pa tsiku) ndi metformin, kuchuluka kwa shuga m'magazi kumatsika komanso omwe amatenga glimepiride (6 mg 1 nthawi patsiku).
Panalibe kusiyana kwakukulu pazotsatira zakuchepetsa shuga. Nthawi yomweyo, odwala omwe ali mgulu la mankhwala a Galvus Met adakumana ndi hypoglycemia nthawi 10 kochepa poyerekeza ndi omwe amachitidwa ndi glimepiride ndi metformin. Panalibe milandu ya hypoglycemia yayikulu kwa odwala omwe amatenga Galvus Met kwa chaka chonse.
Momwe Mapiritsi A shuga a Galvus Amagwiritsidwira Ntchito ndi Insulin
Galvus anali woyamba mankhwala a matenda ashuga mu gulu la DPP-4 inhibitor, lomwe lidalembetsedwa kuti ligwiritsidwe ntchito limodzi ndi insulin. Monga lamulo, limayikidwa ngati sizingatheke kuyendetsa matenda a shuga a 2 limodzi ndi chithandizo chokhacho cha basal chokha, ndiye kuti insulin.
Kafukufuku wa 2007 adayesa kuyendetsa bwino ndiku chitetezo cha kuwonjezera galvus (50 mg 2 kawiri pa tsiku) motsutsana ndi placebo. Odwala adatenga nawo gawo omwe adakhazikika pamatumbo a glycated hemoglobin (7.5-11%) pokana jakisoni wa "sing'anga" wa insulin yemwe alibe gawo la Hagedorn protramine (NPH) pamitengo yoposa 30 magawo / tsiku.
Odwala 144 adalandira galvus limodzi ndi jakisoni wa insulin, odwala 152 omwe ali ndi matenda a shuga a 2 adalandira placebo kumbuyo kwa jakisoni wa insulin. Mu gulu la vildagliptin, kuchuluka kwa hemoglobin wa glycated kwambiri kunachepa ndi 0,5%. Mu gulu la placebo, ndi 0,2%. Mwa odwala omwe ali ndi zaka zopitilira 65, Zizindikiro ndizabwino koposa - kutsika kwa 0.7% kumbuyo kwa galvus ndi 0,1% chifukwa chotenga placebo.
Pambuyo powonjezera galvus ndi insulin, chiopsezo cha hypoglycemia chinachepa kwambiri, poyerekeza ndi mankhwala a shuga, jakisoni wa "sing'anga" NPH-insulin. Mu gulu la vildagliptin, chiwerengero chonse cha hypoglycemia chinali 113, mgulu la placebo - 185. Komanso, palibe vuto limodzi la hypoglycemia lomwe lidadziwika ndi mankhwala a vildagliptin. Panali malo 6 otere mu gulu la placebo.
Zotsatira zoyipa
Mwambiri, galvus ndi mankhwala otetezeka kwambiri. Kafukufuku akutsimikizira kuti chithandizo cha matenda amtundu wa 2 omwe ali ndi mankhwalawa samakulitsa chiwopsezo cha matenda amtima, mavuto a chiwindi, kapena vuto la chitetezo chamthupi. Kutenga vildagliptin (chophatikiza yogwira m'mapiritsi a galvus) sikukula thupi.
Poyerekeza ndi mafuta achilengedwe omwe amachepetsa shuga, komanso ndi placebo, galvus siziwonjezera chiopsezo cha kapamba. Zotsatira zake zoyipa zimakhala zofatsa komanso zosakhalitsa. Zosawonetseka kwambiri:
- chiwindi ntchito (kuphatikizapo hepatitis);
- angioedema.
Zomwe zimayambitsa zotsatirazi ndizoyambira 1/1000 mpaka 1/10,000 odwala.
Mankhwala a shuga a Galvus: contraindication
Contraindication poika mapiritsi a shuga Galvus:
- mtundu 1 matenda a shuga;
- mimba ndi mkaka wa m`mawere;
- matenda ashuga ketoacidosis;
- Hypersensitivity pamagawo a mankhwala.
