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Maalmahan, cudurka beerka dufanka leh ee aan khamriga ahayn (NAFLD) wuxuu noqday sababta ugu weyn ee cudurka beerka ee joogtada ah ee Shiinaha iyo xitaa adduunka. Noocyada cudurka waxaa ka mid ah steatohepatitis cagaarshow fudud, steatohepatitis aan khamriga ahayn (NASH) iyo cirrhosis iyo kansarka beerka ee la xiriira. NASH waxaa lagu gartaa ururinta dufanka xad-dhaafka ah ee hepatocytes iyo dhaawaca unugyada iyo caabuqa, oo leh ama aan lahayn fibrosis cagaarshow. Darnaanta beerka fibrosis ee bukaanka NASH waxay si dhow ula xiriirtaa saadaalinta beerka ee liidata (cirrhosis iyo dhibaatooyinkeeda iyo kansarka beerka hepatocellular), dhacdooyinka wadnaha iyo xididdada dhiigga, malignancies ka baxsan, iyo dhammaan-sababta dhimashada. NASH waxay si xun u saameyn kartaa tayada nolosha bukaanka; si kastaba ha ahaatee, ma jiraan daawooyin ama daawayno loo ogolaaday in lagu daweeyo NASH.

Daraasad dhowaan la sameeyay (ENLIVEN) oo lagu daabacay joornaalka New England Journal of Medicine (NEJM) ayaa muujisay in pegozafermin ay wanaajisay labadaba beerka fibrosis iyo bararka beerka ee bukaannada NASH ee aan cirrhotic ahayn ee biopsy la xaqiijiyay.

Xarunta badan, randomized, double-indhon, placebo-kontaroolay tijaabada bukaan-socodka ee Wajiga 2b, oo uu qabtay Professor Rohit Loomba iyo kooxdiisa kiliinikada ee Jaamacadda California, San Diego School of Medicine, waxay diiwaan gashadeen 222 bukaan oo leh heerka biopsie-xaqiijiyay F2-3 NASH intii u dhaxaysay Sebtembar 28, 2021 iyo Agoosto 15, 2022 ayaa si aan kala sooc lahayn loo qoondeeyay. duritaan, 15 mg ama 30 mg wiigii hal mar, ama 44 mg hal mar 2 asbuuc) ama placebo (hal mar todobaadkii ama hal mar 2 asbuuc). Dhibcaha ugu dambeeya waxaa ka mid ah ≥ heerka 1 horumarinta fibrosis iyo wax horumar ah oo NASH ah. NASH ayaa la xaliyay iyada oo aan la helin horumar fibrotic ah. Daraasadu waxay sidoo kale samaysay qiimeyn badbaado.

Ka dib 24 toddobaad oo daaweyn ah, saamiga bukaanada leh ≥ marxaladda 1 ee hagaajinta fibrosis oo aan ka sii darin NASH, iyo saamiga bukaanada qaba dib-u-celinta NASH iyo wax ka sii daraya fibrosis ayaa si aad ah uga sarreeya saddexda kooxood ee Pegozafermin marka loo eego kooxda placebo, oo leh kala duwanaansho aad u weyn oo bukaannada lagu daaweeyo 44 mg hal mar labadii toddobaadba ama 30 mg. Dhanka badbaadada, pegozafermin waxay la mid tahay placebo. Dhacdooyinka xun xun ee ugu badan ee la xidhiidha daawaynta pegozafermin waxay ahaayeen lallabbo, shuban, iyo erythema ee goobta la duray. Marxaladdan tijaabada ah ee 2b, natiijooyinka hordhaca ah waxay soo jeedinayaan in daaweynta pegozafermin ay wanaajiso fibrosis beerka.

pegozafermin, oo loo adeegsaday daraasaddan, waa analoog glycolated muddo dheer shaqaynaysa oo ah factor koritaanka fibroblast aadanaha 21 (FGF21). FGF21 waa hoormoon dheef-shiid kiimikaad oo uu soo daayo beerku, kaas oo door ka ciyaara nidaaminta xuubka iyo dheef-shiid kiimikaadka gulukooska. Daraasado hore ayaa muujiyay in FGF21 ay leedahay saameyn daweyn ah oo ku saabsan bukaanada NASH iyadoo kordhinaysa dareenka insulinta beerka, kicinta oksaydhka dufanka dufanka leh, iyo joojinta lipogenesis. Si kastaba ha noqotee, nolosha nuska gaaban ee dabiiciga ah FGF21 (qiyaastii 2 saacadood) waxay xaddidaysaa isticmaalkeeda daaweynta kiliinikada ee NASH. pegozafermin waxay isticmaashaa tignoolajiyada pegylation glycosylated si ay u kordhiso nolosha nuska ah ee dabiiciga ah FGF21 oo ay wanaajiso hawsheeda bayoolojiga.

Marka laga soo tago natiijooyinka togan ee tijaabada bukaan-socodka ee Wajiga 2b, daraasad kale oo dhowaan lagu daabacay Dabiiciga Dabiiciga ah (ENTRIGUE) ayaa muujisay in pegozafermin ay sidoo kale si weyn hoos ugu dhigtay triglycerides, kolesteroolka aan HDL, apolipoprotein B, iyo steatosis cagaarshow ee bukaanada qaba hypertriglyceridemia daran, taas oo laga yaabo inay saameyn togan ku yeelato yaraynta halista dhacdooyinka wadnaha ee bukaanada Naafada ah.

Daraasadahaani waxay soo jeedinayaan in pegozafermin, oo ah hoormoon dheef-shiid kiimikaad, ay siin karto faa'iidooyin dheef-shiid kiimikaad badan bukaanada qaba NASH, gaar ahaan sababtoo ah NASH waxaa laga yaabaa in loo magacaabo cudurka beerka dufanka leh ee mustaqbalka. Natiijooyinkani waxay ka dhigayaan dawo aad muhiim u ah daawaynta NASH. Isla mar ahaantaana, natiijooyinkan daraasaddan togan waxay ku taageeri doonaan pegozafermin marxaladda 3 tijaabo caafimaad.

In kasta oo laba toddobaadba 44 mg ama toddobaadle 30 mg pegozafermin daawaynta lagu gaadhay barta asaasiga ah ee taariikhiga ah ee tijaabada, muddada daawaynta daraasaddan waxay ahayd 24 toddobaad oo keliya, heerka u hoggaansanaanta kooxda placebo waxay ahayd kaliya 7%, taas oo aad uga hooseysa natiijooyinka daraasadihii hore ee kiliinikada ee socday toddobaadyada 48. Kala duwanaanshaha iyo nabadgelyadu ma isku mid baa? Marka la eego kala duwanaanshaha NASH, ballaaran, xarumo badan, tijaabooyin caafimaad oo caalami ah ayaa loo baahan yahay mustaqbalka si loogu daro bukaanada waaweyn iyo kordhinta muddada daaweynta si loo qiimeeyo waxtarka iyo badbaadada daawada.