西咪匹韦治疗基因1型丙型肝炎的有效性和安全性的Meta分析

Efficiency and safety of simeprevir in treatment of genotype 1 hepatitis C:a meta-analysis

目的:评价西咪匹韦治疗基因1型丙型肝炎的疗效和安全性。方法:检索EMBASE、PubMed、The Cochrane Central Register of Controlled Trials、clinicaltrials.gov、CNKI全文数据库、万方数据库中关于西咪匹韦治疗基因1型丙型肝炎的疗效和安全性的随机对照试验,检索起始日期为2000年1月1日,截止时间为2016年8月8日。采用RevMan5.3对纳入的研究进行Meta分析。结果:共7项研究符合纳入标准入选本Meta分析,共纳入2 301例患者。分析结果显示西咪匹韦快速病毒学应答(RVR)、持续早期病毒应答(SVR12)、持续病毒学应答(SVR24)等获得率均明显高于对照组(P<0.000 1),病毒复发率明显低于对照组(P<0.000 1);100 mg组西咪匹韦RVR,SVR12,SVR24,病毒复发率等指标明显优于对照组(P<0.001),而150 mg组除了SVR24与对照组对比,差异无统计学意义外(P>0.05),其余指标均优于对照组(P<0.001)。西咪匹韦组一般不良反应发生率与对照组相比,差异无统计学意义(P>0.05),与临床治疗相关的不良反应中除了对光敏感发生率高于对照组,其余不良反应如皮疹、瘙痒、中性粒细胞减少、贫血事件发生率均与对照组对比无统计学差异(P>0.05)。结论:西咪匹韦用于治疗基因1型丙肝具有较好疗效及安全性。100 mg西咪匹韦较150 mg西咪匹韦用于治疗基因1型丙肝疗效更佳。

OBJECI＇IVE To evaluate the efficiency and safety of simeprevir in treatment of genotype l hepatitis C. METH- ODS Different databases were searched,including EMBASE,PubMed and Cochrane Central Register of randomized controlled trial,clinicaltrials, gov, Chinese full text database, CNKI, Wanfang database. Meta analysis was performed by using RevMan 5.3. RESULTS A total of 7 studies including 2 301 patients met the inclusion criteria. Compared to control group, RVR, SVR12 and SVi24of simeprevir were significantly higher （P〈0. 000 1） ,viral relapse rate was significantly lower （P〈0. 000 1）. Com- pared to control group, simeprevir 100 mg group showed obviously higher RVR, SVR12, SVR24, viral relapse rate （P〈0. 001）, and simeprevir 150 mg group showed significantly different indexes except for SVR24 rates （P〈0. 00l ）. No significant differ- ence was found between simeprevir groups and control group in nonspecific adverse events, and other adverse reactions including rash, pruritus, neutropenia, anemia incidence rates. Photosensitvity incidence rates were higher in simeprevir groups than those in the control group. CONCLUSION Simeprevir is safe and effective in treatment of genotype 1 hepatitis C combined with pe- gylated interferon and ribavirin, and simeprevir 100 mg is a better choice as compared with simeprevir 150 mg.