Abstract: Background　Revefenacin is the first anti-muscarinic drug that needs to be administered only once a day for maintenance therapy in patients with chronic obstructive pulmonary disease（COPD）.There is no systematic review of its treatment of COPD in China.Objective　To perform a systematic review of the efficacy and safety of revefenacin in COPD，to provide a basis for the selection of drug treatments for COPD.Methods　The databases of CNKI，Wanfang Data Knowledge Service Platform，CQVIP，CBM，PubMed，EMBase，The Cochrane Library and ClinicalTrials.gov were searched for clinical studies of revefenacin in treating COPD from inception to May 2019.Literature enrollment was performed using strict inclusion criteria and exclusion criteria.The first author，publication time，NCT number，country（region），intervention，sample size，sex，age，race，course of treatment，indices of efficacy〔trough forced expiratory volume in one second（trough FEV1），peak FEV1，response rate to St.George's Respiratory Questionnaire（SGRQ）〕 and indices of safety（common and serious adverse reactions）regarding the eligible studies were recorded.The Cochrane Collaboration's tool for assessing risk of bias was used to evaluate the methodological quality.RevMan 5.3 was used for meta-analysis.Results　A total of 6 randomized controlled trials were included，with a total sample size of 2 175 participants，and high methodological quality.According to the result of meta-analysis：the improvement of trough FEV1 in remifenaxine group was better than that in placebo group 〔MD=146.78，95%CI（133.52，160.05），P<0.000 01〕.Peak FEV1 〔MD=129.50，95%CI（115.69，143.31），P<0.000 01〕，and the SGRQ response rate in remifenaxine group were lower than those of placebo group 〔OR=1.60，95%CI（1.29，1.98），P<0.000 1〕.Both groups showed no significant differences in the incidence of severe adverse reactions〔OR=0.93，95%CI（0.44，1.94），P=0.84〕，upper respiratory tract infection 〔OR=1.42，95%CI（0.72，2.82），P=0.31〕，headache 〔OR=0.88，95%CI（0.49，1.58），P=0.66〕，and cough 〔OR=1.06，95%CI（0.62，1.82），P=0.82〕.The incidence of dyspnea in remifenaxine group was higher than that in placebo group 〔OR=0.54，95%CI（0.33，0.87），P=0.01〕.Conclusion　Revefenacin is effective and safe in the treatment of COPD.

Key words: Pulmonary disease, chronic obstructive；Revefenacin；COPD；Treatment outcome；Safety；Meta-analysis

摘要： 背景　雷芬那辛是第一个仅需一天给药一次的用于慢性阻塞性肺疾病（COPD）患者维持治疗的抗毒蕈碱类药物，国内尚未见其治疗COPD的系统评价。目的　系统评价雷芬那辛治疗COPD的疗效与安全性，为COPD的药物治疗提供选择依据。方法　计算机检索中国知网、万方数据知识服务平台、维普网、中国生物医学文献数据库、PubMed、EMBase、The Cochrane Library和ClinicalTrials.gov等数据库，收集雷芬那辛相关临床研究，检索时限从建库至2019年5月。根据制定的纳入标准、排除标准对收集的文献进行严格筛选，记录第一作者、发表时间、NCT编号、国家地区、干预措施、样本例数、性别、年龄、种族、疗程、疗效指标〔第1秒用力呼气量谷值（trough FEV1）、第1秒用力呼气量峰值（peak FEV1）、圣乔治呼吸问卷（SGRQ）应答率〕及安全性指标（严重不良反应、常见不良反应）。采用Cochrane协作网偏倚风险评估工具对纳入的研究进行质量评价，使用RevMan 5.3软件对疗效和安全性指标进行Meta分析。结果　本研究共纳入6项符合纳入标准的随机对照研究，合计样本量2 175例，文献质量总体较高。Meta分析结果显示：雷芬那辛组改善trough FEV1效果优于安慰剂组〔MD=146.78，95%CI（133.52，160.05），P<0.000 01〕，peak FEV1〔MD=129.50，95%CI（115.69，143.31），P<0.000 01〕、SGRQ应答率低于安慰剂组〔OR=1.60，95%CI（1.29，1.98），P<0.000 1〕。雷芬那辛组严重不良反应〔OR=0.93，95%CI（0.44，1.94），P=0.84〕、上呼吸道感染〔OR=1.42，95%CI（0.72，2.82），P=0.31〕、头痛〔OR=0.88，95%CI（0.49，1.58），P=0.66〕、咳嗽〔OR=1.06，95%CI（0.62，1.82），P=0.82〕发生率与安慰剂组比较，差异均无统计学意义。雷芬那辛组呼吸困难发生率高于安慰剂组〔OR=0.54，95%CI（0.33，0.87），P=0.01〕。结论　雷芬那辛治疗COPD疗效确切，安全性较好。

关键词: 肺疾病, 慢性阻塞性, 雷芬那辛, 慢性阻塞性肺疾病, 治疗结果, 安全性, Meta分析