1.Effects of Roflumilast on Lung Function of Asian Patients with Chronic Obstructive Pulmonary Disease :a Meta-analysis
Sha CHENG ; Zelan DAI ; Chuang XIAO ; Zhiying WENG ; Qiang RAO ; Hongyan WANG ; Weimin YANG
China Pharmacy 2019;30(8):1112-1117
OBJECTIVE: To systematically evaluate the effects of roflumilast on lung function of Asian patients with chronic obstructive pulmonary disease (COPD), and to provide evidence-based reference for rational drug use in the clinic. METHODS: Retrieved from Cochrane library, PubMed, Embase, CBM, CNKI, VIP and Wanfang database, RCTs about roflumilast or roflumilast combined with routine treatment or placebo (trial group) versus routine treatment or placebo (control group) in the treatment of Asian COPD patients were collected. After literature screening, data extraction and quality evaluation with Cochrane bias risk evaluation tool, Meta-analysis was conducted by using Rev Man 5.2 software. RESULTS: Totally 6 RCTs were included, involving 1 494 patients. Meta-analysis showed that pre-bronchodilator FEV1 (pre-FEV1) [MD=75.19, 95%CI(53.21, 97.17), P<0.000 01], post-bronchodilator FEV1 (post-FEV1) [MD=56.60, 95%CI(27.56, 85.63), P=0.000 1], forced vital capacity (FVC) [MD=43.67, 95%CI (15.91,71.43), P=0.002], average flow rate of post-bronchodilator 25%-75% of forced vital capacity (post-FEF25%-75%) [MD=14.58, 95%CI (8.43, 20.73), P<0.001], the incidence of diarrhea [RR=5.06, 95%CI (1.26,20.27), P=0.02], respiratory infection [RR=1.94, 95%CI (1.30,2.90), P=0.001], decreased appetite [RR=7.43, 95%CI (2.94,18.79), P=0.001], body weight decrease [RR=5.46, 95%CI (2.12,14.03), P=0.001], headache [RR=7.73, 95%CI (1.42,42.16), P=0.02], dizziness [RR=3.44, 95%CI (1.28,9.27), P=0.01], gastritis [RR=5.09, 95%CI (1.49, 17.45), P=0.01] and anorexia [RR=5.06, 95%CI (1.97, 13.00), P=0.001] in trial group were significantly higher than control group; St. George’s Respiratory Questionnaire (SGRQ) total score [MD=-5.82, 95%CI(-7.77, -3.87), P<0.001], respiratory symptom score [MD=-1.67, 95%CI (-2.51, -0.84), P<0.001], activity limited score [MD=-1.55, 95%CI (-2.14, -0.97), P<0.001] and disease impact score [MD=-2.59, 95%CI (-3.40,-1.79), P<0.001] of trial group were significantly lower than those of control group. CONCLUSIONS: Roflumilast can improve lung function and dyspnea in Asian COPD patients, but it can increase the risk of ADR.