恩替卡韦与阿德福韦酯治疗慢性乙型肝炎患者12周和24周疗效的Meta评价

Evaluation of naive efficacy of entecavir and adefovir at week 12 and 24 in patients with chronic hepatitis B

目的比较恩替卡韦与阿德福韦酯治疗核苷类初治的HBeAg阳性慢性乙型肝炎患者的疗效。方法检索2003年1月-2010年5月公开发表的有关恩替卡韦与阿德福韦酯治疗HBeAg阳性的核苷类初治的慢性乙型肝炎患者的随机对照临床研究论文。采用检验分析研究间的异质性,以相对危险度为疗效分析统计量进行合并分析并绘制森林图。疗效判定指标包括血清HBVDNA检测不到(阴转)、血清ALT复常和血清HBeAg转阴。结果共检索到212篇文献,经筛选最终纳入1篇英文文献和3篇中文文献。分析结果显示,恩替卡韦治疗12周患者血清HBVDNA阴转率(P=0.0002,RR=1.74)、ALT复常率(P=0.04,RR=1.34)显著高于阿德福韦酯治疗组;恩替卡韦治疗24周患者血清HBVDNA阴转率(P=0.20)、血清HBeAg转阴率(P=0.27)与阿德福韦酯组无统计学差异。结论恩替卡韦的起效较快,但在治疗24周时,两药的抗病毒效果已无显著性差异。

Objective To evaluate the efficacy between entecavir and adefovir dipivoxil in hepatitis B e antigen-positive nucleos（t）ide-naive patients with chronic hepatitis B.Methods Chinese and English papers（randomized controlled clinical trials） about comparison of efficacy between entecavir and adefovir dipivoxil in hepatitis B e antigen-positive nucleos（t）ide-naive patients with chronic hepatitis B were searched from January 2003 to May 2010 online.Heterogeneity was examined by Chi-square test,the relative risk was calculated and forest-graph was drawn.The evaluated index contained undetectable serum HBV DNA,serum ALT normalization and HBeAg loss.Results 212 articles were totally found,and only one English and three Chinese articles fit well for the study were included.Meta analysis showed that the rates of undetectable serum HBV DNA（P=0.0002,RR=1.74）and serum ALT normalization（P=0.04,RR=1.34）in entecavir-treated patients at week 12 were higher than those in adefovir dipivoxil-treated,but there was no statistic significances as respect to the rates of undetectable serum HBV DNA（P=0.20） and HBeAg loss（P=0.27）between the two groups at week 24.Conclusion Entecavir has a quicker effect in decreasing serum HBV DNA and normalizing serum ALT at early stage than adefovir dipivoxil,however,the efficacies are the same at week 24.