摘要
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。
Objectives To conduct a meta-analysis to evaluate the efficacy and safety of thymosin-α1 for HBeAg-positive chronic hepatitis B.
Methods We searched MEDLINE, Science Citation Index, Current Content Connect, Cochrane Controlled Trial Register and Chinese Biomedical Database （CBMdisc） to September 15, 2005, and screened the references of eligible trials by hand-searching. Randomized controlled trials （RCTs） comparing thymosin-α1 with non-antiviral interventions （placebo, no treatment and standard care） in patients with HBeAg positive chronic hepatitis B were eligible for inclusion. We conducted quality assessment and data extraction by two independent investigators with disagreement resolved by discussion. We used chi-square test and Galbraith plot to detect the heterogeneity, and used fixed （Mantel-Haenzel） and random effect model （DerSimonian-Laird） to pool the trials. When the results in two models differed, the results of random effect were reported. Subgroup analysis was performed to detect whether the duration affected the efficacy of thymosin.
Results Four RCTs were included. It was found that the rate of loss of HBeAg was 38.8% in thymosin, significantly higher than that of 12.4% in control groups （RR 2.22, 95%CI 1.55 to 3.21, P=0.000）. Loss of HBV-DNA was 36.9% in thymosin-α1, significantly higher than that of 13.8% in control groups （RR 2.18, 95%CI 1.50 to 3.17, P=0.000）. Both short-duration （8-13 weeks） and regular duration （26-52 weeks） of thymosin-α1 achieved higher loss of HBeAg and HBV-DNA. The complete response rate was 32.3% in thymosin-α1, significantly higher than the control, 11.3% （RR 2.91, 95%CI 1.71 to 4.94, P=0.000）. No statistical significance was found for HBeAg seroconversion and ALT normalization. No significant adverse drug reactions were found.
Conclusions Thymosin-α1 might be efficacious in loss of HBeAg and HBV-DNA, and complete response for patients with HBeAgpositive chronic hepatitis B. Little evidence was available on HBeAg seroconversion, normalization of ALT, loss of HBsAg, and histological response. Further high-quality RCTs were needed for confirmation.
出处
《中国循证医学杂志》
CSCD
2006年第3期189-194,共6页
Chinese Journal of Evidence-based Medicine
基金
卫生部卫生技术评估项目课题。
