替比夫定与恩替卡韦治疗慢性乙型肝炎第48周的荟萃分析

Telbivudine and entecavir for hepatitis B therapy of 48th week:a meta-analysis

目的系统评价替比夫定与恩替卡韦治疗慢性乙型肝炎第48周的疗效。方法计算机检索Cochrane Library、PubMed、EBSCOS、SpringerLink、万方、中国知网、维普、中国国家科技图书文献中心(2008年1月至2012年2月);在图书馆手工检索馆藏杂志。纳入替比夫定与恩替卡韦治疗慢性乙型肝炎的随机和半随机对照试验。按Cochrane系统评价方法,评价纳入研究的方法学质量,并提取有效数据进行分析。结果最终纳入11项研究,其中替比夫定组632例,恩替卡韦组628例。慢性乙型肝炎抗病毒治疗第48周,替比夫定HBV DNA转阴率77.9%,恩替卡韦HBV DNA转阴率81.1%[OR=0.81,95%CI(0.61,1.09),P>0.05];替比夫定e抗原消失率37.4%,恩替卡韦e抗原消失率24.8%[OR=1.80,95%CI(1.21,2.67),P<0.05];替比夫定e抗原血清转换率27.3%,恩替卡韦e抗原血清转换率15.3%[OR=2.11,95%CI(1.42,3.12),P<0.05];替比夫定ALT复常率76.8%,恩替卡韦ALT复常率72.9%[OR=1.24,95%CI(0.92,1.68),P>0.05];替比夫定耐药率4.9%,恩替卡韦耐药率为0.0%[OR=7.42,95%CI(1.32,41.60),P<0.05]。两者均未发现严重不良反应。结论治疗慢性乙型肝炎第48周,替比夫定与恩替卡韦在HBV DNA转阴和ALT复原方面差异无统计学意义;替比夫定在e抗原转阴和e抗原血清转换方面优于恩替卡韦;恩替卡韦在耐药性方面优于替比夫定。

Objective To assess the therapeutic effect of 48th week between telbivudine and entecavir. Methods The researchers conducted a systemic literature search using the electronic databases Cochrane 1.ibrary, PubMed, SpringerLink, WANFANG DATA, CNKI, Nation Science and Technology Library of China （January 2008 to February 2012） for English and Chinese language studies . Hand-made search for magazines in library as well. Randomized and quasi randomized controlled trials were included in the meta-analysis. Methods of Cochrane system assessment was used to evaluate the quality of methodology. Results Eleven RCT were included which telbivudine 632, entecavir 628. At 48th week, the rates of undetectable HBV DNA were 77.9% vs 81.1 [OR = 0. 81,95%CI（0. 61,1. 09） ,P〉0.05） . The rates of HBeAg loss were 37.4% vs 24.8%[OR = 1.80,95%CI（1.21,2.671,P〈0.05]. While at 48th week, the rates of HBeAg seroconversion were 27.3% vs 15.3%[OR = 2.11,95%CI（1. 42,3.12）,P〈[0. 05]. At 48th week the rates of ALT normalization were 76.8% vs 72.9%[OR=1.24,95%CI（0.92,1.681,P〉0.05]. The rates of drug resistance were 4.9% vs 0.0%[OR： 7. 42,95%CI （1.32,41.60） ,P〈0.05]. There was no severe adverse reaction. Conclusion Telbivudine has similar impact on cleaning HBV DNA and ALT normalization with entecavir at 48th week. However telbivudine has more effectiveness on HBeAg loss and HBeAg seroconversion. Entecavir has less drug resistance.