amakuru

Muri iki gihe, indwara y’umwijima y’umwijima (NAFLD) yabaye intandaro y’indwara y’umwijima idakira mu Bushinwa ndetse no ku isi. Indwara zirimo indwara yoroshye ya hepatike steatohepatitis, steatohepatitis idafite inzoga (NASH) hamwe na cirrhose na kanseri y'umwijima. NASH irangwa no kwegeranya ibinure byinshi muri hepatocytes no kwangirika kwa selile no gutwika, hamwe na fibrosis ya hepatike cyangwa idafite. Uburemere bwa fibrosis yumwijima kubarwayi ba NASH bufitanye isano rya bugufi no kumenya umwijima mubi (cirrhose ningaruka zayo na kanseri ya hepatocellular carcinoma), indwara zifata umutima, imitsi, indwara mbi zidasanzwe, nimpamvu zose zitera urupfu. NASH irashobora kugira ingaruka mbi kubuzima bw'abarwayi; ariko, nta biyobyabwenge cyangwa imiti byemewe kuvura NASH.

Ubushakashatsi buherutse gukorwa (ENLIVEN) bwasohotse mu kinyamakuru cyitwa New England Journal of Medicine (NEJM) bwerekanye ko pegozafermin yazamuye fibrosis y'umwijima ndetse no gutwika umwijima mu biopsy byemejwe na sirrhotique abarwayi ba NASH.

Ikigeragezo cyinshi, giteganijwe, gihumye-impumyi, kigenzurwa na perezidansi ya Phase 2b y’ubuvuzi, cyakozwe na Porofeseri Rohit Loomba hamwe n’itsinda rye ry’amavuriro muri kaminuza ya Californiya, Ishuri ry’Ubuvuzi rya San Diego, ryandikishije abarwayi 222 bafite icyiciro cya F2-3 NASH hagati ya 28 Nzeri 2021 na 15 Kanama 2022. icyumweru cyangwa rimwe mu byumweru 2). Iherezo ryibanze ryarimo ≥ icyiciro cya 1 kunoza fibrosis kandi nta terambere rya NASH. NASH yakemuye nta terambere rya fibrotic. Ubushakashatsi kandi bwakoze isuzuma ry'umutekano.

Nyuma y'ibyumweru 24 bivurwa, umubare w'abarwayi bafite ≥ icyiciro cya 1 cyateye imbere muri fibrosis kandi nta na NASH ikabije, kandi umubare w'abarwayi bafite ikibazo cyo gusubira inyuma kwa NASH kandi nta gukomera kwa fibrosis wagaragaye cyane mu matsinda atatu ya Pegozafermin ugereranije no mu itsinda rya placebo, hakaba hari itandukaniro rikomeye ku barwayi bavuwe na mg 44 mu byumweru bibiri cyangwa 30 mg rimwe mu cyumweru. Kubijyanye numutekano, pegozafermin yasaga na placebo. Ibintu bibi byakunze kugaragara bijyanye no kuvura pegozafermin ni isesemi, impiswi, na erythema aho batewe inshinge. Muri iki cyiciro cya 2b, ibisubizo byibanze byerekana ko kuvura hamwe na pegozafermin biteza fibrosis yumwijima.

pegozafermin, ikoreshwa muri ubu bushakashatsi, ni analogue ikora igihe kirekire igereranya ya fibroblast yo gukura kwabantu 21 (FGF21). FGF21 ni imisemburo ya endogenous metabolike isohoka n'umwijima, igira uruhare mu kugenga metabolism ya lipide na glucose. Ubushakashatsi bwibanze bwerekanye ko FGF21 igira ingaruka zo kuvura abarwayi ba NASH mu kongera insuline yumwijima, gutera aside irike, no kubuza lipogenezi. Nyamara, igice cya kabiri cyubuzima busanzwe bwa FGF21 (amasaha agera kuri 2) kigabanya imikoreshereze yacyo mubuvuzi bwa NASH. pegozafermin ikoresha tekinoroji ya glycosylated kugirango yongere igice cyubuzima bwa kamere ya FGF21 no kunoza ibikorwa byibinyabuzima.

Usibye ibisubizo byiza muri iki cyiciro cy’ubuvuzi cya Phase 2b, ubundi bushakashatsi buherutse gusohoka mu buvuzi bwa Kamere (ENTRIGUE) bwerekanye ko pegozafermin yagabanije cyane triglyceride, cholesterol itari HDL, apolipoproteine ​​B, na hepatike ya hepatike ku barwayi bafite hypertriglyceridemia ikabije, ishobora kugira ingaruka nziza ku kugabanya ibyago by’indwara zifata umutima.

Ubu bushakashatsi bwerekana ko pegozafermin, nka hormone ya metabolike ya endogenous, ishobora gutanga inyungu nyinshi zo guhinduranya abarwayi bafite NASH, cyane cyane ko NASH ishobora guhindurwa izina ry’umwijima w’umwijima mu gihe kiri imbere. Ibisubizo bituma bigira imiti ikomeye cyane yo kuvura NASH. Muri icyo gihe, ibisubizo byiza byubushakashatsi bizafasha pegozafermin mugice cya 3 cyamavuriro.

Nubwo byombi biweekly 44 mg cyangwa buri cyumweru 30 mg pegozafermin ivura yageze ku ndunduro y’ibanze y’igeragezwa, igihe cyo kwivuza muri ubu bushakashatsi cyari ibyumweru 24 gusa, kandi igipimo cyo kubahiriza mu itsinda rya placebo cyari 7% gusa, kikaba cyari munsi cyane y’ibyavuye mu bushakashatsi bw’ubuvuzi bwabanje kumara ibyumweru 48. Itandukaniro n'umutekano birasa? Bitewe n'uburinganire bwa NASH, binini, bigizwe n’ibigo byinshi, amavuriro mpuzamahanga arakenewe mu gihe kizaza kugira ngo abarwayi benshi barusheho no kongera igihe cyo kwivuza kugira ngo basuzume neza imikorere n’umutekano w’ibiyobyabwenge.