5种直接抗病毒药物治疗慢性丙型病毒性肝炎有效性与安全性比较的Meta分析
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篇名: 5种直接抗病毒药物治疗慢性丙型病毒性肝炎有效性与安全性比较的Meta分析
TITLE: Meta-analysis of Efficacy and Sa fety of 5 Direct Antiviral Agents in the Treatment of Chronic Hepatitis C Infection
摘要: 目的:比较格卡瑞韦(GLE)/哌仑他韦(PIB)、来迪派韦(LDV)/索磷布韦(SOF)、SOF/维帕他韦(VEL)、艾尔巴韦(EBR)/格拉瑞韦(GZR)复合制剂和达诺瑞韦(DNV)+聚乙二醇干扰素联合利巴韦林(P/R)等5种直接抗病毒药物方案治疗慢性丙型病毒性肝炎的有效性与安全性。方法:计算机检索PubMed、Embase、Cochrane图书馆、WebofScience、中国知网、维普网、万方数据等数据库,检索时间均为建库起至2020年6月,收集5种直接抗病毒药物方案治疗慢性丙型病毒性肝炎的随机对照试验(RCT)。筛选文献、提取数据后,采用Cochrane系统评价员手册5.1.0推荐的偏倚风险评估工具对纳入文献质量进行评价,采用Stata15.0软件进行Meta分析。结果:共纳入48项RCT,试验组患者共计12227例。Meta分析结果显示,获得持续病毒学应答(SVR)率由高到低依次为GLE/PIB>LDV/SOF>SOF/VEL>EBR/GZR>DNV+P/R,其中GLE/PIB、LDV/SOF、SOF/VEL、EBR/GZR的加权SVR率均在95%以上。任何严重的不良事件发生率、任何不良事件发生率由低到高依次均为EBR/GZR<GLE/PIB<SOF/VEL<LDV/SOF<DNV+P/R;恶心/呕吐发生率由低到高依次为GLE/PIB<LDV/SOF<EBR/GZR<SOF/VEL<DNV+P/R;皮疹发生率由低到高依次为LDV/SOF<GLE/PIB<SOF/VEL<EBR/GZR<DNV+P/R;失眠发生率由低到高依次为GLE/PIB<EBR/GZR<SOF/VEL<LDV/SOF<DNV+P/R。结论:GLE/PIB、LDV/SOF、SOF/VEL、EBR/GZR治疗慢性丙型病毒性肝炎的有效率较高且接近,尤以GLE/PIB治疗的加权SVR率最佳;安全性方面,以EBR/GZR、GLE/PIB相对较好。
ABSTRACT: OBJECTIVE:To com pare the efficacy and safety of 5 direct antiviral agents in the treatment of chronic hepatitis C infection as glecaprevir (GLE)/pibrentasvir(PIB),ledipasvir(LDV)/sofosbuvir(SOF),SOF/velpatasvir(VEL),elbasvir(EBR)/ grazoprevir(GZR)compound preparation and danoprevir (DNV)+ peginterferon combined with ribavirin (P/R). METHODS : Retrieved from PubMed ,Embase,Cochrane Library ,Web of Science ,CNKI,VIP,Wanfang database and other databases ,RCTs about 5 direct antiviral agents in the treatment of chronic hepatitis C infection were collected during the inception to Jun. 2020. After literature screening and data extraction ,the quality of included literatures were evaluated with bias risk evaluation tool recommended by Cochrane system evaluator manual 5.1.0. Meta-analysis was performed by using Stata 15.0 software. RESULTS : A total of 48 RCTs with 12 227 patients in trial group were included. Results of Meta-analysis showed that the descending order of sustained virological response (SVR)rate was GLE/PIB >LDV/SOF>SOF/VEL>EBR/GZR>DNV+P/R;weighted SVR rates of GLE/PIB,LDV/SOF,SOF/VEL and EBR/GZ were more than 95%. The incidence of any severe adverse event and adverse event in ascending order was EBR/GZR <GLE/PIB<SOF/VEL<LDV/SOF<DNV+P/R. The incidence of nausea/vomiting in ascending order was GLE/PIB <LDV/SOF<EBR/GZR<SOF/VEL<DNV+P/R. The incidence of rash in ascending order was LDV/SOF < GLE/PIB<SOF/VEL<EBR/GZR<DNV + P/R. The incidence of insomnia from low to high was GLE/PIB <EBR/GZR<SOF/ VEL<LDV/SOF<DNV+P/R. CONCLUSIONS :GLE/PIB,LDV/SOF,SOF/VEL and EBR/GZR have higher and similar effective rates in the treatment of chronic hepatitis C ,especially the weighted SVR rate of GLE/PIB is the best ,and the safety of EBR/GZR and GLE/PIB is relatively better.
期刊: 2021年第32卷第10期
作者: 金敏,陈平钰,李洪超,马爱霞
AUTHORS: JIN Min,CHEN Pingyu ,LI Hongchao ,MA Aixia
关键字: 慢性丙型病毒性肝炎;直接抗病毒药物;有效性;安全性;Meta分析
KEYWORDS: Chronic hepatitis C infection ;Direct antiviral
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