恩替卡韦治疗中国慢性乙型肝炎患者疗效的Meta分析

Meta analysis of the efficacy of entecavir in treatment of patients with chronic hepatitis Bin China

目的评价恩替卡韦（ETV）治疗中国慢性乙型肝炎患者的疗效。方法检索2006年1月至2013年10月所有以ETV为试验组和拉米夫定（LAM）为对照组的随机对照试验（RCT）资料,查阅所有文献的参考文献作为补充,两名研究者独立采用Jadad评分对全部纳入文献进行质量评价,异质性分析使用χ^2检验,以比值比（OR）为效应量进行Meta分析。结果共有7篇RCT文献纳入本研究,其中中文文献3篇,英文文献4篇,研究结果显示,ETV组的HBV DNA低于检测下限的比率和ALT复常率均高于LAM组（OR=4.12,95%CI：3.37～5.05,P〈0.001;OR=1.60,95%CI：1.31～1.96,P〈0.001）。ETV组的ALT复燃率低于LAM组（OR=0.56,95%CI：0.35～0.91,P=0.02）。两种药物的不良反应发生率相当（OR=1.06,95%CI：0.85～1.31,P=0.61）。结论恩替卡韦可强效抑制慢性乙型肝炎患者体内的HBV DNA、提高生化学应答、肝组织学改善率,同时具有和其他核苷酸类药物一样的安全性和耐受性。

Objective To evaluate the efficacy of entecavir in treatment of patients with chronic hepatitis B in China. Methods Papers from January 2006 to October 2013 were searched, all data were retrieved from randomized controlled trial（RCT）. The supplement were from all documents of reference. All patients were divided into two groups： entecavir（ETV） group and lamivudine（LAM） group. Two investigators assessed the quality and extracted the data independently. Heterogeneity was examined by Chi-square test. The effect size for the Meta analysis was evaluated by odds ratio（OR）. Results There were seven RCTs were included, among which three references in Chinese and four in English. It showed that negative conversion ratio of HBV DNA and normalization of ALT in ETV group were significantly higher than that in LAM group（OR = 4.12, 95%CI： 3.37-5.05, P〈 0.001; OR = 1.60, 95%CI： 1.31-1.96, P〈 0.001）. The recurrence rate of ALT in ETV group was significantly lower than that in LAM group（OR = 0.56, 95%CI： 0.35-0.91, P = 0.02）. There were no significant difference in the adverse effects rates between ETV group and LAM group（OR = 1.06, 95%CI： 0.85-1.31, P = 0.61）. Conclusions Entecavir could effectively inhibit HBV DNA and improve the biochemical responses with liver histology period for patients with chronic hepatitis B. The tolerance of ETV are similar to other nucleotide analogues.