恩替卡韦和拉米夫定治疗慢性乙型肝炎的Meta分析

Meta-analysis of Entecavir and Lamivudine for Treatment of Chronic Hepatitis B

目的系统评价恩替卡韦和拉米夫定治疗慢性乙型肝炎的疗效与安全性。方法检索Cochrane Library,PubMed,Ovid,Elsevier,中国期刊全文数据库(CNKI),万方数字化期刊全文库,中文科技期刊全文数据库(维普)公开发表的相关随机对照试验(RCT),并手工检索纳入研究的参考文献。对纳入的研究进行质量评价和数据提取,采用RevMan5.2软件进行Meta分析。当I2<50%时认为纳入研究结果同质性较好,采用固定效应模型计算合并统计量;当I2≥50%时,则选择随机效应模型计算合并统计量。结果最终纳入27篇文献。Meta分析结果显示,对于HBV DNA转阴率、ALT复常率,HBeAg转阴率和HBeAg血清学转化率,恩替卡韦组均显著高于拉米夫定组;在不良反应发生率方面,2组无统计学差异。结论当前的研究显示,恩替卡韦对慢性乙型肝炎的疗效优于拉米夫定,2药的不良反应发生率相似。相关结果需要样本量更大,设计更严谨的大型多中心的临床随机对照试验。

Objective To systematically review the efficacy and safety of entecavir versus lamivudine for the treatment of chronic hepatitis B patients. Methods Published randomized controlled trials （RCTs） of entecavir and lamivudine were identified from Cochrane Library, PubMed, Ovid, Elsevier, CNKI, WANFANG database and VIP. A manual search of references of the included researches was also conducted. Then the quality of the included studies were evaluated, and data were extracted. Meta-analysis was performed by using RevMan 5.2 software. If I^2 〈 50% , the fixed effect model were applied to analyze the results ; while if I^2 〉 50%, the random effect model were chosen. Results A total of 27 trials were included in the analysis. Meta-analysis showed that the rate of undetectable HBV DNA, ALT normalization, HBeAg loss and HBeAg seroconversion in entecavir group were obviously higher than lamivudine group. There were no statistical differences in the occurrence of adverse reaction in both groups. Conclusions The current research showed that entecavir was more effective than lamivudine, and the adverse reactions of the 2 drugs were similar. The limited quality of the evidence in the literature underlines the need for future randomized clinical trials in this area.