Objective To systematically review the efficacy and safety of roflumilast for patients with chronic obstructive pulmonary disease (COPD). Methods We searched PubMed, Web of Science, SpringerLink, Ovid, ClinicalTrials.gov, CBM, WanFang 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 RevMan 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. Conclusion Current evidence shows roflumilast could significantly improve pulmonary function, reduce the mean exacerbation rate in COPD patients, and has good safety.

Citation： DONGMiao, JIANGBing. Efficacy and Safety of Roflumilast for Patients with Stable COPD: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2015, 15(4): 458-463. doi: 10.7507/1672-2531.20150076 Copy