A zamanin yau, cutar hanta mai ƙiba (NAFLD) ta zama babban abin da ke haifar da cututtukan hanta na yau da kullun a China har ma a duniya. Bakan cutar ya haɗa da steatohepatitis mai sauƙi na hanta, steatohepatitis mara barasa (NASH) da cirrhosis mai alaƙa da ciwon hanta. NASH yana da alaƙa da tarin kitse mai yawa a cikin hanta da haifar da lalacewar salula da kumburi, tare da ko ba tare da hanta fibrosis ba. Mummunan fibrosis na hanta a cikin marasa lafiya na NASH yana da alaƙa da alaƙa da rashin lafiyar hanta (cirrhosis da rikice-rikicensa da ciwon hanta), abubuwan da ke faruwa na zuciya da jijiyoyin jini, cututtuka na rashin ciwon hanta, da kuma mutuwa duka. NASH na iya yin illa ga ingancin rayuwar marasa lafiya; duk da haka, ba a yarda da wasu magunguna ko magunguna don magance NASH ba.
Wani bincike na baya-bayan nan (ENLIVEN) da aka buga a cikin New England Journal of Medicine (NEJM) ya nuna cewa pegozafermin ya inganta duka hanta fibrosis da kumburin hanta a cikin biopsy-tabbatar da marasa lafiya NASH marasa cirrhotic.
Multicenter, bazuwar, makafi biyu, gwajin gwaji na gwaji na Phase 2b, wanda Farfesa Rohit Loomba da ƙungiyarsa na asibiti suka gudanar a Jami'ar California, Makarantar Magunguna ta San Diego, sun yi rajistar marasa lafiya 222 tare da matakin biopsie-tabbatar da F2-3 NASH tsakanin Satumba 28, 2021 da Agusta 15, 202min bazuwar. allura, 15 MG ko 30 MG sau ɗaya a mako, ko 44 MG sau ɗaya kowane mako 2) ko placebo (sau ɗaya a mako ko sau ɗaya kowane mako biyu). Abubuwan ƙarshe na farko sun haɗa da ≥ mataki na 1 ingantawa a cikin fibrosis kuma babu ci gaba na NASH. NASH an warware ba tare da ci gaban fibrotic ba. Har ila yau, binciken ya gudanar da tantancewar aminci.
Bayan makonni 24 na jiyya, yawancin marasa lafiya tare da ≥ mataki na 1 ingantawa a cikin fibrosis kuma babu wani mummunan rauni na NASH, da kuma yawan marasa lafiya tare da regression na NASH kuma ba tare da muni da fibrosis ba sun kasance mafi girma a cikin ƙungiyoyin kashi uku na Pegozafermin fiye da a cikin rukunin placebo, tare da ƙarin bambance-bambance a cikin marasa lafiya da aka bi da su tare da 44 MG sau ɗaya kowane mako biyu ko kowane mako 30. Dangane da aminci, pegozafermin yayi kama da placebo. Mafi yawan al'amuran da suka fi dacewa da maganin pegozafermin sune tashin zuciya, gudawa, da erythema a wurin allurar. A cikin wannan gwaji na 2b, sakamakon farko ya nuna cewa jiyya tare da pegozafermin yana inganta fibrosis na hanta.
pegozafermin, wanda aka yi amfani da shi a cikin wannan binciken, shine analog na glycolated mai aiki mai tsawo na ƙwayar fibroblast girma factor 21 (FGF21). FGF21 wani hormone ne na rayuwa wanda hanta ke ɓoyewa, wanda ke taka rawa wajen daidaita tsarin lipid da glucose metabolism. Nazarin da suka gabata sun nuna cewa FGF21 yana da tasirin warkewa akan marasa lafiya na NASH ta hanyar haɓaka haɓakar insulin hanta, haɓaka iskar oxygen mai kitse, da hana lipogenesis. Koyaya, ɗan gajeren rabin rayuwar FGF21 na halitta (kimanin awanni 2) yana iyakance amfani da shi a cikin maganin asibiti na NASH. pegozafermin yana amfani da fasahar pegylation glycosylated don tsawaita rabin rayuwar FGF21 na halitta da inganta ayyukanta na halitta.
Bugu da ƙari, sakamakon sakamako mai kyau a cikin wannan gwaji na asibiti na Phase 2b, wani binciken da aka buga a cikin Nature Medicine (ENTRIGUE) ya nuna cewa pegozafermin kuma ya rage girman triglycerides, wadanda ba HDL cholesterol, apolipoprotein B, da kuma hanta steatosis a marasa lafiya tare da hypertriglyceridemia mai tsanani, wanda zai iya samun tasiri mai kyau a kan rage hadarin cututtukan zuciya da jijiyoyin jini a cikin marasa lafiya da NAS.
Wadannan nazarin sun ba da shawarar cewa pegozafermin, a matsayin hormone na rayuwa, na iya samar da fa'idodin rayuwa masu yawa ga marasa lafiya tare da NASH, musamman saboda ana iya canza sunan NASH suna da alaƙa da cututtukan hanta mai haɗari a nan gaba. Wadannan sakamakon sun sa ya zama mahimmancin mahimmancin magani don maganin NASH. A lokaci guda, waɗannan ingantaccen sakamakon binciken za su goyi bayan pegozafermin cikin gwaji na asibiti na lokaci 3.
Ko da yake duka biyu na 44 MG ko mako-mako 30 MG pegozafermin jiyya sun cimma mahimmin ƙarshen ƙarshen gwajin, tsawon lokacin jiyya a cikin wannan binciken shine kawai makonni 24, kuma ƙimar yarda a cikin rukunin placebo shine kawai 7%, wanda ya ragu sosai fiye da sakamakon binciken da aka yi a baya na asibiti na tsawon makonni 48. Shin bambance-bambance da tsaro iri daya ne? Dangane da nau'in NASH, mafi girma, tsakiya mai yawa, ana buƙatar gwaje-gwaje na asibiti na duniya a nan gaba don haɗawa da yawan marasa lafiya da kuma tsawaita lokacin jiyya don kimanta inganci da amincin miyagun ƙwayoyi.
Lokacin aikawa: Satumba-16-2023