摘要
目的评价拉米夫定+胸腺肽a(1LAM+Ta1)与拉米夫定(LAM)单用治疗e抗原阳性慢性乙肝(CHB)患者的疗效与安全性。方法计算机检索CENTRAL、PubMed、CBM、CNKI,均从建库检索至2008年12月,并追踪已获文献的参考文献,纳入LAM+Ta1与单用LAM的随机对照试验(RCT)。由2名研究者独立进行质量评价及数据提取,采用RevMan5.0软件进行Meta分析。结果共纳入23个RCT,合计1488例患者。Meta分析结果显示,主要结局指标(HBeAg血清转换),在治疗结束时以及停药后随访1年,试验组均优于对照组,其差异有统计学意义[RR(95%CI)分别为2.89(2.40,3.48)和4.99(2.99,8.31)];次要结局指标(HBV-DNA阴转、HBeAg阴转、ALT复常、HBV-YMDD变异、完全应答、HBsAg阴转),在治疗结束时及停药后随访1年,试验组均优于对照组;与单药治疗组相比,试验组不良反应无明显增加。结论对HBeAg阳性CHB患者,LAM+Ta1联合疗法可能优于LAM单药疗法;但受纳入文献质量影响,以上结论尚需高质量的临床试验进一步证实。
Objective To compare lamivudine monotherapy versus lamivudine-thymosin alpha-1 combination therapy for HBeAg positive chronic hepatitis B. Methods We searched CENTRAL （Issue 4, 2008）, PubMed （up to December 2008）, the Chinese Biomedical database （CBM, up to December 2008）, and CNKI （up to December 2008）. We also scanned references of all included studies and pertinent reviews. Quality assessment and data extraction were conducted by two reviewers independently. Meta-analyses were conducted using RevMan 5.0. Results We identified 23 trials involving 1 488 patients. According to the results of meta-analyses, the HBeAg seroconversion rate of the combination therapy group was higher than that of the monotherapy group, both at the end of the treatment and the one year follow-up （RR=2.89, 95%CI 2.40 to 3.48; RR=4.99, 95%CI 2.99 to 8.31）; and there were also significant differences between the two groups for secondary outcomes including HBV-DNA negative, ALT normalization, etc.. There was no significant difference between the two groups in adverse reaction. Conclusion Lamivudine-thymosin alpha-1 combination therapy might be more effective than lamivudine monotherapy for HBeAg positive chronic hepatitis B. However, the results should be interpreted with caution because of the low quality of the included studies. High-quality, large scale randomized controlled trials are needed to further prove the results.
出处
《中国循证医学杂志》
CSCD
2009年第8期904-909,共6页
Chinese Journal of Evidence-based Medicine
