恩替卡韦治疗中国人慢性乙型肝炎疗效的系统评价

The efficacy of entecavir treatment on chronic hepatitis B in China:a meta-analysis

目的系统评价恩替卡韦（entecavir，ETV）治疗中国成人慢性乙型肝炎（chronichepati—tisB，CHB）的疗效。方法检索国内2005-2008年2月公开发表ETV治疗成人CHB的随机对照试验（RCT）并提取纳入研究的特征信息，运用Revman 4．2软件对HBV DNA转阴率、AⅡ复常率、HBeAg阴转率及药物的不良反应进行分析。结果共有7篇RCT文献纳入本研究，包含833例CHB患者，对照组使用拉米夫定（1amivudine，LVD）或阿德福韦酯（adefovir，ADV）治疗。研究表明，ETV组HBV DNA转阴率、ALT复常率均明显高于对照组（76．4％VS43．0％，89．6％ vs 77．7％），OR值分别为4．46（95％CI为3．28-6．06，P〈0．00001）和2．48（95％CI1．67-3．48，P〈0．00001）；两组HBeAg阴转率类似（23．3％ vs 20．2％），0R值为1．82（95％CI为0．46-7．15，P=0．39）；入选文献所报道的药物不良反应也无明显差异。结论恩替卡韦可强效、安全抑制HBV复制、改善肝功能，治疗国人CHB的疗效优于拉米夫定或阿德福韦酯。

Objective To systematically evaluate the effect of entecavir on treatment of Chinese patients with chronic hepatitis B. Methods Randomized clinical trials which compared the efficacy and safety of entecavir with lamivudine or adefovir for chronic hepatitis B in Chinese patients were identified from computer-based literature. The rate of HBV DNA negative, ALT normalization, HBeAg negative and adverse reactions were evaluated by Revman 4.2. Results Seven randomized clinical trials including 833 cases were analyzed. As compared with lamivudine or adefovir, enteeavir significantly increased the rate of HBV DNA negative and ALT normalization （76.4% versus 43.0% ,89.6% versus 77.7% ）, the total OR were 4.46 （95% CI 3.28-6.06, P 〈0.00001 ） and 2.48 （ 95% CI 1.67-3.48, P 〈 0. 00031 ） respectively. There were no significant difference of HBeAg negative rate and adverse reactions between two groups （ 23.3% versus 20.2% ）, with OR 1.82 （ 95% CI0.46 -7.15, P=0.39 ）. Conclusions Enteeavir is superior to lamivudine or adefovir for chronic hepatitis B in Chinese patients on inhibition of HBV replication, improvement of liver function, efficacy and safety.