富马酸丙酚替诺福韦用于慢性乙型肝炎的快速卫生技术评估  

Rapid Health Technology Assessment of Tenofovir Alafenamide Fumarate for Chronic Hepatitis B

作　　者：朱宝强 胡佳强 杨诗语 张明名 龙恩武[1] ZHU Baoqiang;HU Jiaqiang;YANG Shiyu;ZHANG Mingming;LONG Enwu(Department of Pharmacy,Sichuan Academy of Medical Sciences·Sichuan Provincial People′s Hospital,Chengdu,Sichuan,China 610072;Department of Pharmacy,The First People′s Hospital in Shuangliu District·West ChinaHospital of Sichuan University,Chengdu,Sichuan,China 610200)

机构地区：[1]四川省医学科学院·四川省人民医院药学部,四川成都610072 [2]四川省成都市双流区第一人民医院·四川大学华西空港医院药学部,四川成都610200

出　　处：《中国药业》2024年第22期137-141,共5页China Pharmaceuticals

基　　金：四川省人民医院科研基金资助项目[2017LY16]。

摘　　要：目的评估富马酸丙酚替诺福韦(TAF)治疗慢性乙型肝炎(CHB)的有效性、安全性及经济性。方法计算机检索PubMed、Embase、The Cochrane Library、Web of Science、中国知网、万方、中国生物医学文献服务系统数据库及国外卫生技术评估(HTA)机构的官方网站,检索时限为各数据库自建库起至2023年10月31日。由2名研究者独立筛选文献并提取数据,采用HTA checklist、系统评价评估测量工具(AMSTAR 2)量表及卫生经济学评价报告标准(CHEERS 2022)对纳入文献进行质量评价。结果共纳入文献13篇,其中HTA报告1篇、系统评价/Meta分析6篇、药物经济学研究6篇。TAF在乙型肝炎病毒(HBV)-DNA转阴率、乙型肝炎表面抗原转阴率,乙型肝炎e抗原转阴率及血清学转换率,丙氨酸氨基转移酶复常率方面效果均不劣于富马酸替诺福韦二吡呋酯(TDF)和恩替卡韦(ETV),但其血脂异常不良反应发生风险较高。由于价格差异,TAF治疗CHB在我国尚无显著经济学优势,但在我国东部经济较发达地区具有一定价值;在部分其他国家(如沙特、泰国等),由于药品价格、纳入成本等因素,TAF的经济性相对较好。结论TAF治疗CHB的疗效和安全性与TDF和ETV基本相当,且在我国尚无显著的经济学优势。Objective To evaluate the efficacy,safety and economy of tenofovir alafenamide fumarate(TAF)in the treatment of chronic hepatitis B(CHB).Methods The relevant literature in the PubMed,Embase,The Cochrane Library,Web of Science,CNKI,WanFang,SinoMed and official websites of foreign health technology assessment(HTA)institutions from the inception of each database or website to October 31,2023 was searched.The literature was independently screened and data were extracted by two researchers.The quality of included literature was evaluated by the HTA checklist,the A Measurement Tool to Assess Systematic Reviews(AMSTAR 2)and the Consolidated Health Economic Evaluation Reporting Standards(CHEERS 2022).Results A total of 13 literature was included,including one HTA report,six systematic reviews/Meta-analyses and six pharmacoeconomic studies.The efficacy of TAF was not inferior to that of tenofovir disoproxil fumarate(TDF)and entecavir(ETV)in the hepatitis B virus(HBV)-DNA clearance rate,hepatitis B surface antigen(HBsAg)clearance rate,hepatitis B e antigen(HBeAg)clearance rate,HBeAg serological conversion rate,and alanine aminotransferase(ALT)recovery rate,but there was a risk of adverse reactions due to lipid abnormalities.Due to price differences,TAF in the treatment of CHB did not yet have significant economic advantages in China,but it had a certain value in the economically developed areas in eastern China.In some other countries(such as Saudi Arabia,Thailand,etc.),TAF had good economy due to the factors such as drug prices and included costs.Conclusion TAF in the treatment of CHB is comparable to TDF and ETV in the efficacy and safety,while it has no significant economic advantage in China.

关 键 词：慢性乙型肝炎 富马酸丙酚替诺福韦 核苷酸类似物 快速卫生技术评估 

分 类 号：R969.3[医药卫生—药理学] R575.1[医药卫生—药学]