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【drug-news】钟南山院士6.14发表在The Lancet的文章：
Effect of carbocisteine on acute exacerbation of chronic obstructive pulmonary disease (PEACE Study): a randomised placebo-controlled study
Prof Jin-Ping Zheng MD a, Prof Jian Kang MD b, Prof Shao-Guang Huang MD c, Ping Chen MD d, Prof Wan-Zen Yao MD e, Prof Lan Yang MD f, Prof Chun-Xue Bai MD g, Prof Chang-Zheng Wang MD h, Prof Chen Wang MD i, Bao-Yuan Chen MD j, Yi Shi MD k, Chun-Tao Liu MD l, Prof Ping Chen MD m, Qiang Li MD n, Zhen-Shan Wang MD o, Yi-Jiang Huang MD p, Zhi-Yang Luo MD q, Fei-Peng Chen MD r, Jian-Zhang Yuan MD s, Ben-Tong Yuan MD t, Hui-Ping Qian MD u, Rong-Chang Zhi MD v and Prof Nan-Shan Zhong MD
Summary
Background
Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation, and has many components including mucus hypersecretion, oxidative stress, and airway inflammation. We aimed to assess whether carbocisteine, a mucolytic agent with anti-inflammatory and antioxidation activities, could reduce the yearly exacerbation rate in patients with COPD.
Methods
We did a randomised, double-blind, placebo-controlled study of 709 patients from 22 centres in China. Participants were eligible if they were diagnosed as having COPD with a postbronchodilator forced expiratory volume in 1 s (FEV1) to forced vital capacity (FVC) ratio (FEV1/FVC) of less than 0·7 and an FEV1 between 25% and 79% of the predicted value, were aged between 40 and 80 years, had a history of at least two COPD exacerbations within the previous 2 years, and had remained clinically stable for over 4 weeks before the study. Patients were randomly assigned to receive 1500 mg carbocisteine or placebo per day for a year. The primary endpoint was exacerbation rate over 1 year, and analysis was by intention to treat. This trial is registered with the Japan Clinical Trials Registry (http://umin.ac.jp/ctr/index/htm) number UMIN-CRT C000000233.
Findings
354 patients were assigned to the carbocisteine group and 355 to the placebo group. Numbers of exacerbations per patient per year declined significantly in the carbocisteine group compared with the placebo group (1·01 [SE 0·06] vs 1·35 [SE 0·06]), risk ratio 0·75 (95% CI 0·62–0·92, p=0·004). Non-significant interactions were found between the preventive effects and COPD severity, smoking, as well as concomitant use of inhaled corticosteroids. Carbocisteine was well tolerated.
Interpretation
Mucolytics, such as carbocisteine, should be recognised as a worthwhile treatment for prevention of exacerbations in Chinese patients with COPD.
Funding
Kyorin Pharmaceuticals.
Affiliations
a. Guangzhou Institute of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College, Guangzhou, China
b. First Affiliated Hospital of China Medical University, Shenyang, China
c. Ruijing Hospital, Shanghai Jiao Tong University Medical School, Shanghai, China
d. Shenyang PLA General Hospital, Shenyang, China
e. Peking University Third Hospital, Beijing, China
f. First Affiliated Hospital, Xi'An Jiao Tong University, Xi'An, China
g. Zhongshan Hospital, Fudan University, Shanghai, China
h. Xin Qiao Hospital, Chongqing, China
i. Chao Yang Hospital, Beijing, China
j. Tianjin General Hospital, Tianjin, China
k. Nanjing PLA General Hospital, Nanjing, China
l. Huaxi Hospital, Chengdu, China
m. Second Xiangya Hospital, Changsha, China
n. Changhai Hospital, Shanghai, China
o. Second Affiliated Hospital of Dalian Medical University, Dalian, China
p. Hainan Province Hospital, Haikou, China
q. First Municipal Hospital, Foshan, China
r. Second Affiliated Hospital of Guangzhou Medical College, Guangzhou, China
s. Red Cross Hospital, Guangzhou, China
t. Second Municipal Hospital, Shenzhen, China
u. Xinhai Hospital, Guangzhou, China
v. Panyu Hospital, Guangzhou, China 再来篇相关新闻：
中广网广州6月16日消息（记者邓文华、通讯员刘丹）钟南山院士等专家领衔的最新研究发现，一种常用的廉价祛痰药物可减少24.5%的慢阻肺急性发作，对COPD常规治疗费用也可剧降85％。这一研究成果日前在国际最权威的医学杂志之一《柳叶刀》上全文发表，并得到著名医学专家的高度评价。
羧甲司坦治疗慢阻肺成果获世界关注
由广州呼吸疾病国家重点实验室（广州医学院第一附属医院广州呼吸疾病研究所、中国科学院生物医药与健康研究所共同组成）钟南山院士与中国医科大学康健教授领衔的全国22家研究中心参与的多中心、随机、双盲、安慰剂对照平行试验研究“羧甲司坦（广州白云山制药总厂出品）治疗慢性阻塞性肺疾病（COPD）”的临床研究结果，于6月14日在国际上最权威的医学杂志之一《柳叶刀》（The Lancet）上全文发表。
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作者:admin@医学,生命科学 2011-06-16 17:14
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