拉米夫定治疗乙肝肝硬化的系统评价和Meta-分析

Lamivudine for hepatitis B virus liver cirrhosis:a meta-analysis of randomized controlled trials

目的应用系统评价和Meta分析评价国内拉米夫定治疗乙肝肝硬化的疗效。方法应用循证医学的系统评价方法，对2000年1月～2006年12月在国内生物医学期刊有关拉米夫定治疗乙肝肝硬化的临床随机对照试验进行质量评价。结果纳入8个RCT（n=578）研究拉米夫定100mg／d治疗乙肝肝硬化的疗效，纳入文献的总体方法学质量较高，4篇Jadad评分为3分以上，但在随机化方法、分配隐藏和盲法的使用方面重视不够。分析结果显示，使用拉米夫定可明显促使ALT复常，对Child—Pugh评分与对照组相比有统计学意义（P〈0．05），短期内使用拉米夫定对HBVDNA转阴率与对照组相比有统计学意义（P〈0．05），但长期则无统计学意义（P〉0．05）。拉米夫定治疗组的HBeAg转阴率与对照组相比无统计学意义（P〉0．05）。结论拉米夫定治疗乙肝肝硬化是安全的，它可使ALT复常，降低Child—Pugh评分，但对HBVDNA和HBeAg转阴率影响不大。

Objective To evaluate the clinical effect of lamivudine for hepatitis B virus liver cirrhosis in china by meta-analysis. Methods The biomedical science periodicals database from January 2000 to Decomber 2006 was searched for randomized controlled trials of lamivudine on hepatis B liver cirrhosis. Results Eight RCTs were included （n = 578 ）. All reported the effect of lamivudine （100 mg/d） on hepatitis B virus liver cirrhosis, the total method quality of included studies was high, four RCTs Jadad scores were over 3, but were insufficient in random way,allocation concealment and blindness. It was found by meta-analysis that lamivudine could normalize ALT. Child-Pugh scores of lamivudine had statistical significance compared with control group, HBV DNA seroconversion in short term had statistical significance compared with control group,but had no statistical significance for a long period. It showed that lamivudine group had no statistical significance in HBeAg seroconversion compared with the control group. Conclusions Lamivudine （ 100 mg/d） is safe and effective for hepatitis B virus liver cirrhosis in normalizing ALT,reducing Child-Pugh scores, but had no enough proof of HBV DNA and reduceing HBeAg seroconversion.