恩替卡韦治疗慢性乙型肝炎的快速卫生技术评估  

Rapid health technology evaluation of entecavir for the treatment of chronic hepatitis B

作　　者：孔滢 肖劲娜 胡智 何礼标[1] 刘立立 万露 胡锦芳[1] 周颖 KONG Ying;XIAO Jin-na;HU Zhi;HE Li-biao;LIU Li-li;WAN Lu;HU Jin-fang;ZHOU Ying(Department of Pharmacy,the First Affiliated Hospital of Nanchang University,Nanchang 330006,China)

机构地区：[1]南昌大学第一附属医院药学部,南昌330006

出　　处：《临床药物治疗杂志》2024年第2期55-62,共8页Clinical Medication Journal

基　　金：重大新药创制科技重大专项(2020ZX09201027)。

摘　　要：目的 评估恩替卡韦治疗慢性乙型肝炎的有效性、安全性和经济性。方法 计算机检索the Cochrane Library、Science Direct、PubMed、Embase、中国生物医学文献服务系统、中国知网、万方数据知识服务平台、维普资讯等相关数据库和有关卫生技术评估网站,收集并分析从数据库建库至2023年8月恩替卡韦治疗慢性乙型肝炎病毒(HBV)感染的研究文献。2名研究者通过相应标准进行质量评价,并对所得结果进行综合分析。结果 共纳入33篇文献,其中卫生技术评估报告1篇,系统评价/meta分析25篇,经济学分析7篇。评估结果显示,在有效性方面,恩替卡韦HBV-DNA阴转率、ALT复常率均优于阿德福韦酯,恩替卡韦对预防HBV再激活效果良好。在安全性方面,恩替卡韦不良反应一般较为轻微,总体不良反应发生率较低,与同类其他药物如拉米夫定和阿德福韦酯等相比无显著差异。在经济性方面,与未进行抗病毒药物治疗相比,口服恩替卡韦具有更好的经济性,相较于联合用药策略,恩替卡韦单药治疗更具有经济性优势。结论 恩替卡韦治疗慢性乙型肝炎具有较好的有效性、安全性和经济性。Objective To evaluate the effectiveness,safety,and economics of entecavir in the treatment of chronic hepatitis B.Methods The Cochrane Library,Science Direct,PubMed,Embase,SinoMed,CNKI,Wanfang Data,VIP databases,and health technology assessment websites were searched by computer.The literature on entecavir for the treatment of chronic HBV infection was collected and analyzed from the inception of the database until August,2023.Two researchers evaluated the quality according to the corresponding criteria and conducted a comprehensive analysis of the obtained results.Results A total amount of 33 literature entries were included in this study,including 1 HTA report,25 systematic reviews/meta-analyses,and 7 pharmacoeconomic studies.In terms of effectiveness,the HBV-DNA negative conversion rate and ALT normalization rate of entecavir were better than those of adefovir,and entecavir had an excellent effect on preventing HBV reactivation.In terms of safety,the adverse reactions of entecavir were generally mild,and the overall incidence were low,there existed no significant difference compared with other drugs such as lamivudine and adefovir.In terms of pharmacoeconomics,compared with patients without antiviral drug treatment,oral entecavir had a better cost performance,and entecavir monotherapy had more economic advantages compared with combination with other therapeutic drugs.Conclusion For chronic hepatitis B treatment,entecavir can achieve excellent outcomes with a low safety risk and decent cost-effectiveness.

关 键 词：恩替卡韦 慢性乙型肝炎 有效性 安全性 经济性 快速卫生技术评估 

分 类 号：R978.7[医药卫生—药品]