文档介绍：阿德福韦酯对比安慰剂治疗慢性乙型肝炎的系统评价和Meta-分析
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作者:王龙龙,唐震,马彬,杨克虎
【摘要】目的系统评价阿德福韦酯对比安慰剂治疗慢性乙型肝炎的效果和安全性。方法采用Cochrane系统评价方法,检索Cochrane Library、PubMed、EMbase、中国生物医学文献数据库、中国期刊全文数据库等数据库,由两名评价员独立筛查文献,评价质量和提取资料。采用χ2检验鉴定研究间异质性,使用随机效应和固定效应模型合并研究,对同质研究进行Meta分析。结果共纳入4个RCT,研究地点均在国外,研究质量均较高,各试验间具有基线可比性。Meta分析结果显示:与安慰剂对比,阿德福韦酯(10mg/d)常规疗程(48周)有助于提高肝组织学改善率[OR=,95%CI(,),]、血清HBV DNA阴转率[OR=,95%CI(,) ,]、血清ALT复常率[OR=,95%CI(,),]。所纳入研究中分别仅一个研究报告了血清HBeAg阴转率的提高[% vs %,]和HBeAg血清转换率的提高[12% vs 6%,]。试验组均体现血清HBV DNA中位数水平下降幅度的增大。结论阿德福韦酯在治疗慢性乙型肝炎中有较佳疗效及安全性。
【关键词】阿德福韦酯;慢性乙型肝炎;安慰剂;有效性;安全性;系统评价;Meta-分析
[Abstract] Objective To assess the efficacy and safety of Adefovir dipivoxil in patients with chronic hepatitis B. Methods Using the Cochrane systematic review methods, Cochrane Library,PubMed,EMbase,Chinese Biomedical Literature Database,Chinese Journal Full-text databases were searched from the beginning to September 2009, and the references of eligible studies were manually screened. Randomized controlled paring Adefovir dipivoxil with placebo in patients with chronic hepatitis B were eligible for inclusion. Two investigators independently assessed the quality and extracted the data. Heterogeneity was examined by Chi-square test. Fixed and random effect meta-analysis were used to analyze the data. Results Four RCTs were included (n=1028). All the study sites were in foreign countries, and the study quality were high, with a parability between the various tests. It was found by Meta-analysis that, compared with placebo, Adefovir dipivoxil (10mg/d,48W) could significantly enhance the rate of liver histology improvement [OR = , 95% CI (,), ] and the rate of serum HBV DNA negative conversion[OR = , 95% CI (,), ], serum ALT normalization rate [OR = , 95% CI (,), ]. There was only one study which reported separately the