Boceprevir联合聚乙二醇干扰素α和利巴韦林治疗基因1型慢性丙型肝炎疗效及安全性Meta分析  

Efficacy and safety of boceprevir combined with peginterferon alfa and ribavirin in treatment of hepatitis C patients with genotype 1 infection:A Meta-analysis

作　　者：张琳[1] 窦志华[1] 秦刚[2] 陈宇峰[3] 

机构地区：[1]南通大学附属第三医院药学部,江苏省南通市226006 [2]南通大学附属第三医院肝病科/南通市肝病研究所,江苏省南通市226006 [3]南通大学附属第三医院中西医结合肝病科,江苏省南通市226006

出　　处：《实用肝脏病杂志》2016年第5期544-548,共5页Journal of Practical Hepatology

基　　金：南通市卫计委青年基金项目(WQ2015032)

摘　　要：目的系统评价Boceprevir联合聚乙二醇干扰素α和利巴韦林治疗基因1型慢性丙型肝炎的疗效及安全性。方法应用计算机检索Medline、CENTRAL和EMBASE数据库中关于Boceprevir联合聚乙二醇干扰素和利巴韦林三联疗法与聚乙二醇干扰素联合利巴韦林二联疗法治疗基因1型慢性丙型肝炎患者的随机对照试验(RCTs)。应用Rev Man 5.3软件进行Meta分析。主要结局指标为持续病毒学应答(SVR)、不良反应事件发生率,次要结局指标为快速病毒学应答(RVR)和复发率。结果纳入4个RCTs,共2211例患者。无论初治或经治患者,三联疗法均能显著提高患者SVR[初治患者:64.08%(737/1150)对42.20%(176/417),OR=0.34,95%CI(0.27,0.42),P<0.00001;经治患者:63.02%(288/457)对21.09%(31/147),OR=0.16,95%CI(0.10,0.24),P<0.00001];三联疗法复发率显著低于二联疗法[11.33%(115/1015)对24.00%(66/275),OR=2.69,95%CI(1.90,3.81),P<0.00001];在获得RVR方面,两组差异无统计学意义[72.11%(843/1169)对51.861%(265/511),OR=0.48,95%CI(0.13,1.78),P=0.28];三联疗法显示出了较高的严重贫血发生率[3.98%(64/1607)对1.46%(9/614),OR=0.33,95%CI(0.16,0.68),P=0.003]、严重不良反应发生率[10.45%(168/1607)对7.33%(45/614),OR=0.66,95%CI(0.48,0.90),P=0.01]和因不良反应事件导致停药的发生率[12.49%(109/873)对5.18%(13/251),OR=0.37,95%CI(0.20,0.67),P=0.001]。结论 Boceprevir联合聚乙二醇干扰素和利巴韦林能显著提高基因1型慢性丙型肝炎初治或经治患者的SVR,减少复发率,但可能增加了严重不良事件发生率。受纳入研究的数量限制,上述结论尚待开展更多高质量研究加以验证。Objective To evaluate the efficacy and safety of boceprevir in combination with peginterferon alfa and ribavirin for treatment of hepatitis C patients with hepatitis C viral genotype 1 infection. Methods MEDLINE,CENTRAL,EMBASE were searched for randomized controlled trial articles published from January 2006 to October 2015 on subject of patients with HCV-G1 infection receiving triple-therapy regimens with boceprevir and peginterferon alfa plus ribavirin. According to the predefined inclusion and exclusion criteria,the included studies were evaluated and analyzed by meta-analysis with RevMan 5.3 software. The primary outcomes was sustained virological response （SVR） and adverse events,and the secondary outcomes included rapid virological response （RVR） and relapse. Results Four RCTs involving 2211 patients were included in this study. The results of meta-analysis showed that the triple-therapy regimens increased SVR [naive：64.08% （737/1150） vs. 42.20%（176/417）,OR=0.34,95% CI （0.27,0.42）,P〈0.00001;and retreatment：63.02%（288/457） vs.21.09%（31/147）,OR=0.16,95%CI （0.10,0.24）,P〈0.00001],and the triple-therapy regimens reduced the risk of relapse in both naive and retreatment patients [11.33%（115/1015） vs.24.00%（66/275）,OR=2.69,95% CI （1.90,3.81）, P〈0.00001],as to the RVR,there was no statistical difference between the two groups [72.11%（843/1169） vs.51.861%（265/511）,OR=0.48,95% CI（0.19,1.78）, P=0.28];the incidence of severe anaemia in triple-therapy regimens was obviously higher than in control group [3.98%（64/1607） vs.1.46%（9/614）,OR=0.33, 95% CI （0.16,0.68）,P =0.003],and the same phenomena was found as to serious adverse events [10.45%（168/1607） vs.7.33% （45/614）,OR=0.66,95% CI （0.48,0.90）,P=0.01] or the discontinuation because of adverse events [12.49%（109/873） vs.5.18%（13/251）,OR=0.37,95% CI（0.20,0.67）,P=0.001]. Conclusion Boceprevir in combination with peginterferon and rib-avirin might increase SVR significantly

关 键 词：慢性丙型肝炎 基因1型 BOCEPREVIR 持续病毒学应答率 随机对照试验 META分析 

分 类 号：R512.63[医药卫生—内科学]