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目的评价胸腺肽α1治疗HBeAg阳性慢性乙型肝炎的疗效和安全性。方法检索MEDLINE,Science Citation Index,Current Content Connect, Cochrane图书馆和CBMdisc(从建库至2005年9月15日),纳入胸腺肽α1与不治疗／安慰剂／支持治疗比较,治疗HBeAg阳性慢性乙型肝炎成年患者的随机对照试验(RCT)。由两名评价员独立评价文献质量和提取资料。各研究间的异质性检验采用x2检验和Galbraith图,若无异质性采用固定效应模型合并分析,若存在使用亚组分析,敏感性分析等方法检测导致异质性的原因,并采用随机效应模型合并数据按疗程进行亚组分析。结果共纳入4个试验,HBeAg阴转率胸腺肽α1组(38．8％)高于对照组 (12．4％),两组间差异有统计学意义[RR 2．22,95％CI(1．55,3．21), P=0．000];HBV-DNA清除率胸腺肽α1组(36．9％)高于对照组(13．8％),差异有统计学意义[RR2．18,95％CI(1．50,3．17),P=0．000]。短疗程(8-13 周)和常规疗程(26-52周)的HBeAg阴转率与HBV-DNA清除率胸腺肽α1组也均优于对照组;胸腺肽α1组完全应答(32．3％)高于对照组(11．3％),差异有统计学意义[RR 2．91,95％CI(1．71,4．94),P=0．000];HBeAg血清转换率和血清ALT水平复常率,两组间差异无统计学意义。所有试验未发现明显不良反应。结论对HBeAg阳性慢性乙型肝炎患者,胸腺肽α1可能有使血清HBeAg和 HBV-DNA阴转效能,但对其他抗病毒指标可能无效。受原研究质量和不同研究干预措施差异的影响,胸腺肽α1的效能尚须更多高质量RCT予以证实。
Objective To evaluate the efficacy and safety of thymosin α1 in the treatment of HBeAg-positive chronic hepatitis B patients. METHODS: MEDLINE, Science Citation Index, Current Content Connect, The Cochrane Library and CBMdisc (from library building to September 15, 2005) were included in the study to compare thymosin α1 with untreated / placebo / supportive care in the treatment of HBeAg-positive chronic type B Randomized controlled trial (RCT) of adult patients with hepatitis. Two reviewers independently evaluated the quality of the literature and extracted the information. Heterogeneity tests between studies using the x2 test and Galbraith plots, if there is no heterogeneity using the fixed effect model merge analysis, if there is a subgroup analysis, sensitivity analysis and other methods to detect the cause of heterogeneity, and using random Effects Model The combined data were subgroup analyzed by course of treatment. Results A total of 4 trials were included. Thymosin α1 group (38.8%) was higher than control group (12.4%) in HBeAg negative rate group, with significant difference between two groups [RR 2.22, 95% CI .55,3.21), P = 0.000]. HBV-DNA clearance rate in thymosin α1 group (36.9%) was higher than that in control group (13.8%), the difference was statistically significant [RR2.18, 95% CI (1.50, 3.17), P = 0.000]. The HBeAg negative rate and HBV-DNA clearance of thymosin α1 group were also better than those of control group in short courses (8-13 weeks) and routine courses (26-52 weeks); thymosin α1 group had complete response (32.3%) In the control group (11.3%), the difference was statistically significant [RR 2.91, 95% CI (1.71, 4.94), P = 0.000]; HBeAg seroconversion and serum ALT levels Normal rate, no significant difference between the two groups. No adverse reactions were found in all the trials. Conclusion In patients with HBeAg-positive chronic hepatitis B, thymosin α1 may have negative effects on serum HBeAg and HBV-DNA, but may not be effective against other antiviral markers. Depending on the quality of the original study and differences in the different research interventions, the efficacy of thymosin α1 needs to be confirmed by more high-quality RCTs.