聚乙二醇干扰素初始联合阿德福韦酯或拉米夫定治疗HBeAg(+)慢性乙型肝炎疗效的系统评价  

Efficacy of Peginterferon Alpha Initially Combined with Lamivudine or Adefovir in Treatment of HBeAg-positive Chronic Hepatitis B:A Systematic Review and Meta-analysis

作　　者：陈邦涛 李晋[3] 冯旭娇 张芸[2] 宋少娟[2] 刘明社[2] 赵中夫[2] 

机构地区：[1]山西医科大学附属第一临床医学院传染科,太原030001 [2]长治医学院附属和平医院传染科,山西长治046000 [3]长治医学院附属和平医院麻醉科,山西长治046000

出　　处：《中国循证医学杂志》2016年第1期79-86,共8页Chinese Journal of Evidence-based Medicine

摘　　要：目的 系统评价聚乙二醇干扰素（PEG-IFNα）初始联合阿德福韦酯（ADV）或拉米夫定（LAM）治疗HBe Ag（＋）慢性乙型肝炎的疗效。方法 计算机检索The Cochrane Library（2014年第11期）、Pub Med、CBM、CNKI、VIP和Wan Fang Data数据库,搜集PEG-IFNα初始联合ADV或LAM治疗HBe Ag（＋）慢性乙型肝炎的相关随机对照试验（RCT）,检索时限均从建库至2014年12月。由2位评价员独立筛选文献、提取资料和评价纳入研究的偏倚风险后,采用Rev Man 5.2软件进行Meta分析。结果 共纳入11个研究,PEG-IFNα初始联合ADV或LAM组793例,PEG-IFNα单药治疗组728例,ADV或LAM单药治疗组510例。Meta分析结果显示：PEGIFNα联合ADV治疗HBe Ag（＋）慢性乙型肝炎患者48周,HBs Ag转换率均明显高于单用PEG-IFNα[8.6%vs.0%,OR=7.73,95%CI（1.53,39.05）,P=0.01]或单用ADV[8.5%vs.0%,OR=7.75,95%CI（1.07,56.23）,P=0.04],HBs Ag转阴率仅明显高于单用ADV[10.5%vs.1.2%,OR=5.56,95%CI（2.14,14.47）,P=0.000 4];PEG-IFNα初始联合LAM治疗HBe Ag（＋）慢性乙型肝炎患者52周,HBs Ag转换率明显高于单用PEG-IFNα[11.6%vs.5.6%,OR=2.21,95%CI（1.04,4.72）,P=0.04];治疗48~52周后随访26周,联合治疗组HBs Ag转阴率或转换率均未显示出明显优于单用PEG-IFNα治疗组（P均〉0.05）。结论 PEG-IFNα初始联合ADV或LAM治疗HBe Ag（＋）慢性乙型肝炎48~52周获得的总体HBs Ag清除率或转换率仍然很低,但较单药治疗可获得更高的HBs Ag血清学转阴率或转换率,受纳入研究的质量和数量所限,本研究结论尚需开展更多高质量研究予以验证。Objective To systematically review the efficacy of peginterferon alpha （PEG-IFNα） initially combined with lamivudine （LAM） or adefovir （ADV） in treatment of HBeAg-positive chronic hepatitis B （CHB） patients. Methods We electronically searched databases including The Cochrane Library （Issue 11, 2014）, PubMed, CBM, CNKI, VIP, and WanFang Data from inception to December 2014, to collect randomized controlled trials （RCTs） about PEG- IFNα initially combined with LAM or ADV for HBeAg-positive CHB. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.2 software. Results A total of 11 RCTs involving 2 031 patients were included. The results of meta-analysis showed that： After 48 weeks of treatment, the HBsAg seroconversion rate of the PEG-IFNα plus ADV group was significantly higher than that of the PEG-IFNa monotherapy group （8.6% vs. 0%, OR=7.73, 95%CI 1.53 to 39.05, P=0.01） or the ADV monotherapy group （8.5% vs. 0%, OR=7.75, 95%CI 1.07 to 56.23, P=0.04）; and the HBsAg seroclearance rate in the combination therapy group was significantly higher than that of the ADV monotherapy group （10.5% vs. 1.2%, OR=5.56, 95%CI to 2.14 to 14.47, P=0.0004）. After 52 weeks of treatment, the HBsAg seroconversion rate of the PEG-IFNa plus LAM group was significantly higher than that of the PEG-IFNα monotherapy group （11.6% vs. 5.6%, OR=2.21, 95%CI 1.04 to 4.72, P=0.04）. After 26 weeks of follow-up, no significant differences were found between the combination therapy group and the PEG-IFNα monotherapy group in HBsAg seroclearance rate and HBsAg seroconversion rate （all P values 〉0.05）. Conclusion Current evidence shows that, compared with PEG-IFNα, LAM, or ADV monotherapy, PEG-IFNα plus LAM or ADV could improve the HBsAg seroclearance or seroconversion rate after 48-52 weeks of treatment for HBeAg-positive CHB, but this effect is still limited. Due to the limited qualit

关 键 词：慢性乙型肝炎 阿德福韦酯 拉米夫定 聚乙二醇干扰素 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]