替诺福韦治疗成人慢性乙型肝炎的快速卫生技术评估

Rapid Health Technology Assessment of Tenofovir in the Treatment of Adult Chronic Hepatitis B

目的为优化治疗成人慢性乙型肝炎(CHB)时替诺福韦(TFV)的使用提供循证证据。方法系统检索PubMed、The Cochrane Library、Embase、中国知网、万方和维普数据库,同时检索卫生技术评估(HTA)机构官方网站及相关数据库。检索时限为各数据库自建库起至2022年8月4日。纳入研究TFV治疗CHB临床有效性和安全性的HTA报告、系统评价/Meta分析及药物经济学研究,评价纳入研究的质量。并通过对纳入证据的研究设计、治疗方案及方法学质量等情况进行综合分析,评价TFV相比其他口服核苷酸类似物(NAs)治疗成人CHB的获益、风险及经济性。结果共纳入23篇系统评价/Meta分析和12篇药物经济学研究。TFV乙型肝炎病毒DNA转阴率、丙氨酸氨基转移酶复常率等有效性指标,降低总体和严重不良反应发生率方面效果不劣于恩替卡韦(ETV),且优于拉米夫定、阿德福韦和替比夫定。在我国医疗环境下,ETV更具有经济学优势。而在部分其他国家,由于药品价格、成本结构和研究设计差异等,TFV的经济性优于ETV。结论TFV治疗成人CHB的近期疗效和安全性与ETV相当,且较其他NAs更佳。TFV在我国尚无经济学优势。

Objective To provide evidence-based evidence for the rational use of tenofovir(TFV)in the treatment of adult chronic hepatitis B(CHB).Methods The health technology assessment(HTA)reports,systematic reviews/Meta-analyses and pharmacoeconomic studies on the clinical effectiveness and safety of TFV in the treatment of CHB in the PubMed,The Cochrane Library,Embase,CNKI,WanFang,VIP,the official websites and related databases of HTA institutions from the inception of each database to August 4,2022 were systematically searched.The quality of included studies was evaluated.The research design,treatment regimen and methodological quality of the included evidence was analyzed comprehensively to evaluate the benefits,risks and economics of TFV compared to other oral nucleotide analogues(NAs)in the treatment of adult CHB.Results A total of 23 systematic reviews/Meta-analyses and 12 pharmacoeconomic studies were included.TFV was not inferior to entecavir(ETV)in terms of the effectiveness indicators(clearance rate of hepatitis B virus DNA,normalization rate of alanine aminotransferase),decrease of the incidence of systemic and serious adverse reactions,and was superior to lamivudine,adefovir and telbivudine.ETV was economical in the medical environment of China,while TFV was more economical than ETV in some other countries due to differences in drug price,cost structure and research design.Conclusion The short-term efficacy and safety of TFV in the treatment of adult CHB is similar to those of ETV and better than those of other NAs.However,TFV has no economical advantage in China.