罗氟司特治疗稳定期COPD疗效与安全性的系统评价

Efficacy and Safety of Roflumilast for Patients with Stable COPD:A Systematic Review

目的系统评价罗氟司特治疗慢性阻塞性肺疾病(COPD)的疗效及安全性。方法计算机检索Pub Med、Web of Science、Springer Link、Ovid、Clinical Trials.gov、CBM、Wang Fang Data、CJFD等数据库,收集罗氟司特治疗COPD的随机对照试验(RCT),检索时限均为建库到2014年12月。由两位研究者按照纳入与排除标准独立筛选文献、提取资料和评价纳入研究的方法学质量后,采用Rev Man 5.3软件进行Meta分析。结果共纳入了10个RCT。Meta分析结果显示:1罗氟司特能显著改善COPD患者的pre-FEV1[WMD=54.82,95%CI(46.36,63.28),P<0.000 01],同时改善其他肺功能指标;2罗氟司特可明显减少COPD急性加重率[RR=0.84,95%CI(0.75,0.94),P=0.002],改善COPD患者TDI评分[WMD=0.23,95%CI(0.04,0.42),P=0.02],但不能改善SGRQ评分[WMD=–0.48,95%CI(–2.39,1.43),P=0.63];3罗氟司特与安慰剂比较,不良事件发生率升高,表现为腹泻、恶心、头痛、体重减轻等。结论罗氟司特治疗COPD患者可显著改善患者的肺功能、减少COPD急性加重率,具有较好的安全性。

Objective To systematically review the efficacy and safety of roflumilast for patients with chronic obstructive pulmonary disease（COPD）. Methods We searched Pub Med, Web of Science, Springer Link, Ovid, Clinical Trials.gov, CBM, Wan Fang Data and CJFD to collect randomized control trials（RCTs） of roflumilast for COPD patients from inception to December 2014. Two reviewers independently screened literatures according to the inclusion and exclusion criteria, extracted data and assessed the methodological quality of included studies. Then, meta-analysis was performed by using Rev Man 5.3 software. Results A total of 10 RCTs were included. The results of meta-analysis showed that. Roflumilast could significantly improve trough FEV1（WMD=54.82, 95%CI 46.36 to 63.28, P〈0.000 01）, and other spirometric parameters; Roflumilast could reduce the exacerbation rate（RR=0.84, 95%CI 0.75 to 0.94, P〈0.000 01）, and improve TDI score（WMD=0.23, 95%CI 0.04 to 0.42, P=0.002）, but did not improve SGRQ score（WMD= –0.48, 95%CI –2.39 to 1.43, P=0.63）; Roflumilast could increase some adverse events including diarrhea, headache, nausea, and weight loss. Conclusions Current evidence shows roflumilast could significantly improve pulmonary function, reduce the mean exacerbation rate in COPD patients, and has good safety.