单位：[1]From the State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Disease, 1st Affi liated Hospital of Guangzhou Medical University, Guangzhou, China[2]Beijing Anzhen Hospital affi liated to Capital Medical University , Beijing, China首都医科大学附属安贞医院[3]Southwest Hospital (First Affi liated Hospital of Third Military Medical University of PLA), Chongqing, China[4]Shengjing Hospital of China Medical University , Shenyang, Liaoning, China中国医科大学附属盛京医院[5]Wuxi People’s Hospital, Wuxi, Jiangsu, China[6]Beijing Friendship Hospital affi liated to Capital Medical University , Beijing, China首都医科大学附属北京友谊医院[7]Zhongshan Hospital Fudan University and Shanghai Respiratory Research Institute , Shanghai, China[8]The General Hospital of Shenyang Military Region of PLA, Shenyang, Liaoning Province, China[9]School of Medicine, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China[10]The First Hospital of China Medical University , Shenyang, Liaoning, China[11]Analytical Science,Takeda Pharmaceuticals International GmbH, Zurich, Switzerland[12]Clinical Science, Takeda Pharmaceuticals International GmbH, Zurich, Switzerland .
Background: Roflumilast is the only oral phosphodiesterase 4 inhibitor indicated for use in the treatment of COPD. Previous studies of roflumilast have predominantly involved European and North American populations. A large study was necessary to determine the efficacy and safety of roflumilast in a predominantly ethnic Chinese population. Methods: In a placebo-controlled, double-blind, parallel-group, multicenter, phase 3 study, patients of Chinese, Malay, and Indian ethnicity (N = 626) with severe to very severe COPD were randomized 1:1 to receive either roflumilast 500 mu g once daily or placebo for 24 weeks. The primary end point was change in prebronchodilator FEV1 from baseline to study end. Results: Three hundred thirteen patients were assigned to each treatment. Roflumilast provided a sustained increase over placebo in mean prebronchodilator FEV1 (0.071 L; 95% CI, 0.046, 0.095 L; P < .0001). Similar improvements were observed in the secondary end points of postbronchodilator FEV1 (0.068 L; 95% CI 0.044, 0.092 L; P < .0001) and prebronchodilator and postbronchodilator FVC (0.109 L; 95% CI, 0.061, 0.157 L; P < .0001 and 0.101 L; 95% CI, 0.055, 0.146 L; P < .0001, respectively). The adverse event profile was consistent with previous roflumilast studies. The most frequently reported treatment-related adverse event was diarrhea (6.0% and 1.0% of patients in the roflumilast and placebo groups, respectively). Conclusions: Roflumilast plays an important role in lung function improvement and is well tolerated in an Asian population. It provides an optimal treatment choice for patients with severe to very severe COPD.
第一作者单位：[1]From the State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Disease, 1st Affi liated Hospital of Guangzhou Medical University, Guangzhou, China
共同第一作者：
通讯作者：
通讯机构：[1]From the State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Disease, 1st Affi liated Hospital of Guangzhou Medical University, Guangzhou, China[*1]The protocol and preliminary results of this study were presented at the 17th Congress of the Asian Pacifi c Society of Respirology, December 15, 2012, Hong Kong, China.
推荐引用方式(GB/T 7714)：
Zheng Jinping,Yang Jinghua,Zhou Xiangdong,et al.Roflumilast for the Treatment of COPD in an Asian Population A Randomized, Double-Blind, Parallel-Group Study[J].CHEST.2014,145(1):44-+.doi:10.1378/chest.13-1252.
APA：
Zheng, Jinping,Yang, Jinghua,Zhou, Xiangdong,Zhao, Li,Hui, Fuxin...&Zhong, Nanshan.(2014).Roflumilast for the Treatment of COPD in an Asian Population A Randomized, Double-Blind, Parallel-Group Study.CHEST,145,(1)
MLA：
Zheng, Jinping,et al."Roflumilast for the Treatment of COPD in an Asian Population A Randomized, Double-Blind, Parallel-Group Study".CHEST 145..1(2014):44-+
医学