干扰素联合恩替卡韦治疗慢性乙型病毒性肝炎初治患者疗效与安全性的系统评价  

Efficacy and Safety of Interferon-alpha Combined with Enticavir for Treatment-naive Chronic Hepatitis B Patients: A Systematic Review

作　　者：贾凡[1] 吴霞[1] 康鹏[1] 高杰[1] 徐春林[1] 刘文娟[1] 蒋桂华[1] 

机构地区：[1]哈尔滨医科大学附属第二医院感染病科,哈尔滨 150081

出　　处：《中国循证医学杂志》2016年第3期319-324,共6页Chinese Journal of Evidence-based Medicine

基　　金：黑龙江省政府博士后资助基金(编号:LRB2010-355);院博士科研基金(编号:BS2011-23)

摘　　要：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 systematically review the efficacy and safety of interferon-alpha（IFN-α） combined with enticavir（ETV） for treatment-na？ve chronic hepatitis B（CHB） patients, so as to provide references for clinical practice. Methods We electronically searched databases including Pub Med, EMbase, The Cochrane Library（Issue 7, 2015）, Web of Science, Wan Fang Data, CNKI, CBM and VIP from inception to July 20 th, 2015, to collect randomized controlled trials（RCTs） about IFN-α combined with ETV versus IFN-α or ETV monotherapy for treatment-na？ve CHB patients. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed using Rev Man 5.3 software. Results A total of 10 RCTs involving 964 patients were included. The results of metaanalysis showed that： For HBV-DNA loss rate, HBe Ag loss rate and HBe Ag seroconversion rate, there were no significant differences between the combination therapy group and the monotherapy group at 12-week of treatment, but the combination therapy group was significantly superior to the monotherapy group at 24- and 48-week of treatment except that there was no significant difference between the combination therapy group and the IFN-α monotherapy group in HBe Ag seroconversion at 48-week of treatment. For rate of ALT normalization, the combination therapy group was superior to the IFN-α monotherapy group at 12- and 24-week of treatment, but there were no significant differences between the combination therapy group and the ETV monotherapy group at 12-, 24-, and 48-week of treatment. For safety, no pooled analysis was performed because different outcomes were reported by included studies. Conclusion IFN-α combined with ETV is superior to IFN-α or ETV monotherapy in decreasing viral load, and promoting HBe Ag loss and HBe Ag seroconversion for treatment-na？ve CHB patients, but the evidence of safety is insufficient. Due to the limited quantity and quality of included studies, th

关 键 词：慢性乙型病毒性肝炎 初治 干扰素联合恩替卡韦 干扰素 恩替卡韦 系统评价 Meta分析 随机对照试验 

分 类 号：R512.62[医药卫生—内科学]