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目的系统评价干扰素联合恩替卡韦治疗慢性乙型病毒性肝炎初治患者的疗效与安全性,为临床治疗提供参考。方法计算机检索PubMed、EMbase、The Cochrane Library(2015年7期)、Web of Science、WanFang Data、CNKI、CBM和VIP数据库,搜集干扰素联合恩替卡韦治疗慢乙肝的相关随机对照试验(RCT),检索时限均从建库至2015年7月20日。由2位评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan5.3软件进行Meta分析。结果共纳入10个研究,964例患者。Meta分析结果显示:对于血清HBV-DNA转阴率、HBeAg转阴率和HBeAg转换率,在治疗12周时,干扰素与恩替卡韦联合用药组较两药单用组均未见明显改善;但在治疗24及48周时,除48周在血清HBeAg转换率方面,联合用药组较单用干扰素组无明显改善外,联合用药组均明显优于两药单用组(P<0.05)。对于ALT复常率,联合用药组在治疗12周和24周时优于单用干扰素组,在48周时与单用干扰素组无显著差异,而联合用药组在12周、24周及48周时与单用恩替卡韦组均无显著差异。在安全性方面,由于各研究报道指标不一,未能进行合并分析。结论干扰素联合恩替卡韦治疗慢性乙型肝炎初治患者在降低病毒载量、促进HBeAg转阴及HBeAg转换方面优于单用干扰素/恩替卡韦治疗,但在安全性方面结论尚不确切。受纳入研究质量和数量的限制,上述结论尚需开展更多大样本高质量的RCT予以验证。
Objective To evaluate the efficacy and safety of interferon combined with entecavir in the treatment of patients with newly diagnosed chronic hepatitis B and provide reference for clinical treatment. Methods We searched PubMed, EMbase, The Cochrane Library (2015 Issue 7), Web of Science, WanFang Data, CNKI, CBM and VIP database for the randomized controlled trial (RCT) of interferon combined with entecavir for chronic hepatitis B From the database to July 20, 2015. After two independent reviewers screened the literature, extracted data and evaluated the risk of inclusion in the study, the Meta-analysis was performed using RevMan 5.3 software. Results A total of 10 studies were included, 964 patients. Meta-analysis showed no significant improvement in serum HBV-DNA negative rate, HBeAg negative rate and HBeAg conversion rate at 12 weeks of treatment compared with the combination of interferon and entecavir At 24 and 48 weeks of treatment, except for 48 weeks, the serum HBeAg conversion rate in the combination group was not significantly improved compared with the interferon group alone. The combination group was significantly better than the two groups alone (P <0.05). For the ALT normalization rate, the combination group was superior to the interferon alone group at 12 weeks and 24 weeks of treatment and no significant difference with the IFN alone group at 48 weeks, while the combination group at 12 weeks, 24 weeks and There was no significant difference between 48 weeks and entecavir alone. In terms of safety, due to the different indicators reported in various studies, failed to conduct a merger analysis. Conclusion Interferon combined with entecavir is superior to interferon / entecavir alone in reducing the viral load, promoting HBeAg negative conversion and HBeAg conversion in patients with newly diagnosed chronic hepatitis B. However, the safety is not conclusive. Subject to the limitations of the quality and quantity of studies, the above conclusion still needs to be verified by a large sample of high-quality RCTs.