摘要目的 评价干扰素联合胸腺肽α1治疗HBeAg阳性慢性乙型肝炎的疗效与安全性.方法 检索PubMed、EBSCO、Cochrane Library、中国生物医学文献光盘数据库、中国科技期刊数据库、万方数据库等,检索年限均从1990年1月-2010年5月,纳入干扰素联合胸腺肽α1与干扰素单药治疗HBeAg阳性慢性乙型肝炎且停药后随访时间至少6个月的随机对照试验.采用RevMan5.0软件进行荟萃分析,并根据不同观测时间点进行亚组分析.结果 经筛选共纳入7个随机对照试验,合计535例患者.荟萃分析结果显示,在治疗结束和随访结束时,联合治疗组的HBVDNA转阴率高于单药组[54.9%比36.3%,比值比(OR)=2.39,95%可信区间(CI)为1.64～3.49,P＜0.01 ; 58.6%比30.7%,OR=3.68,95%CI为2.51～5.41,P＜0.01],ALT复常率高于单药组(74.5%比60.9%,OR=1.94,95% CI为1.26～3.00,P＜0.01 ;74.0%比55.6%,OR=2.36,95% CI为1.54～3.62,P＜0.01),HBeAg转阴率高于单药组(56.9%比36.7%,OR=2.38,95% CI为1.61～3.51,P＜0.01 ; 62.2%比33.2%,OR=3.42,95% CI为2.31～5.06,P＜0.01),HBeAg血清转换率高于单药组(40.1%比29.0%,OR=1.65,95% CI为1.10～2.47,P＜0.05; 47.0%比29.5%,OR=2.13,95% CI为1.43～3.16,P＜0.01); HBsAg转阴率仅在随访结束时高于单药组(9.8%比3.7%,OR=2.92,95% CI为1.09～7.76,P＜0.05).结论 干扰素联合胸腺肽α1对于HBeAg阳性慢性乙型肝炎的抗病毒疗效优于干扰素单药治疗,且不良反应无明显增加.

abstractsObjective To compare the efficacy of interferon and thymosin alpha-1 combination therapy with interferon monotherapy for HBeAg positive chronic hepatitis B. Methods The relevant randomized controlled trials were searched throughout PubMed, EBSCO, Cochrane Library, CBMdisc, VIP,WanFang since Janurary 1990. Studies were included if patients were followed up for at least 6 months after cessation of treatment. Meta-analysis was carried out with RevMan5.0 software. Subgroup analyses were used at different time of observation. Results Seven randomized controlled trials were included(535 patients in total). According to the results of meta-analysis, the combination therapy was remarkably more effective than monotherapy both at the end of the treatment and the follow-up in terms of HBV-DNA negative rate(54.9% vs 36.3%, OR = 2.39, 95% CI = 1.64-3.49, P ＜ 0.01; 58.6% vs 30.7%, OR = 3.68, 95% CI = 2.51-5.41,P ＜ 0.01, respectively), ALT normalization rate (74.5% vs 60.9%, OR = 1.94, 95% CI = 1.26-3.00, P ＜ 0.01;74.0% vs 55.6%, OR = 2.36, 95% CI = 1.54-3.62, P ＜ 0.01, respectively), HBeAg loss rate (56.9% vs 36.7%,OR = 2.38, 95% CI = 1.61-3.51, P ＜ 0.01; 62.2% vs 33.2%, OR = 3.42, 95% CI = 2.31-5.06, P ＜ 0.01,respectively), and HBeAg seroconversion rate (40.1% vs 29.0%, OR = 1.65, 95% CI = 1.10-2.47, P ＜ 0.05;47.0% vs 29.5%, OR = 2.13, 95% CI = 1.43-3.16, P ＜ 0.01, respectively); the HBsAg loss rate of the combination therapy group was significantly higher than that of the monotherapy group only at the end of the follow-up (9.8% vs 3.7%, OR = 2.92, 95% CI = 1.09-7.76, P ＜ 0.05). Conclusion Interferon and thymosin alpha-1 combination therapy achieves superior effect with no increase in the adverse effects as compared to interferon monotherapy for HBeAg positive chronic hepatitis B.