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                您當前位置:網站首頁 >> 醫藥新聞 >> 行業動態 >> 恩替卡韋片新適應癥獲批,慢乙肝合并失代償期肝硬化患者再添福音
               
               
              恩替卡韋片新適應癥獲批,慢乙肝合并失代償期肝硬化患者再添福音
              2019-03-01 13:04:34 來源:丁香園 瀏覽:2421

              國家藥品監督管理局批準了慢乙肝治療一線抗病毒藥物恩替卡韋片(博路定?)的新適應癥,失代償期肝病患者的抗病毒治療。本次適應癥的更新為中國慢乙肝合并失代償期肝硬化患者帶來了福音。

              針對于慢乙肝合并失代償肝硬化患者,治療原則主要包括抗病毒、抗炎保肝等綜合治療方案。其中抗病毒治療是針對病因的關鍵所在。抗病毒治療不僅可顯著改善失代償肝硬化患者的肝功能,還可改善長期結局,降低死亡率。

              根據本次獲批的新適應癥,恩替卡韋片說明書將做出更新。關于適應癥及用法用量部分的更新包括:

              15510905857304.jpg

              1.ETV治療肝硬化失代償患者,循證醫學證據豐富

              ETV用于失代償期肝硬化患者具有豐富的循證醫學證據,本次新適應癥的獲批正是參考了III期臨床研究——048研究和一些真實世界研究的結果。

              048研究是一項1:1隨機、開放性,III期臨床研究,納入191例肝功能失代償(CTP評分≥7)的HBeAg陽性或陰性慢乙肝患者,比較ETV 1 mg/d(n=100)與ADV 10 mg/d(n=91)治療的療效及安全性。96周結果顯示,與ADV組相比,ETV組患者病毒學應答率更高,CTP 評分改善率高于ADV組,MELD評分改善幅度大于ADV組,且耐受性良好。

              除此以外,大量國內外的真實世界研究也證實,ETV用于慢乙肝合并失代償肝硬化患者,可以延長生存期。

              2.ETV上市十余載,百萬中國患者共同見證

              ETV上市13年來,中國大陸使用者累積超過100萬,因而積累了大量循證醫學證據,發表研究論文超過1000篇。以080研究為代表的眾多真實世界研究,更見證了ETV長期的安全性和卓越的療效。

              ETV除了在廣泛普通慢乙肝患者中具有強效、安全的優勢以外,在兒童、老年、高病毒載量、肝硬化、腎功能不全、低磷性骨病等多類特殊人群中表現卓越。

              作為各大指南一線推薦的抗病毒藥物,本次又獲批失代償期肝病的新適應癥,恩替卡韋片將持之以恒竭盡全力同廣大臨床醫生一起,造福更多的慢乙肝患者!

              審批編號:DG-0095-190225-200225

              封面圖來源 站酷海洛PLUS

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              下一篇:輝瑞擬降低 RA 藥物托法替布劑量以減少肺栓塞風險

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