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Twice daily N-acetylcysteine 600 mg for exacerbations of chronic obstructive pulmonary disease (PANTHEON)

Jin Ping Zheng;Fu Qiang Wen;Chun Xue Bai;欢英 万;Jian Kang;Ping Chen;Wan Zhen Yao;Li Jun Ma;Xia Li;Luca Raiteri;Marco Sardina;Yi Gao;Bai Song Wang;南山 钟

Guangzhou Medical College;Sichuan University;Fudan University;Shanghai Jiao Tong University;China Medical University;General Hospital;Peking University;Henan Provincial People's Hospital;Hainan Zambon Pharmaceutical;Innovation and Medical Sciences Department;MedKey Med-Tec Development

发表时间:2014-3

期 刊:The Lancet Respiratory Medicine

语 言:English

U R L: http://www.scopus.com/inward/record.url?scp=84895803870&partnerID=8YFLogxK

摘要

Background: Increased oxidative stress and inflammation has a role in the pathogenesis of chronic obstructive pulmonary disease (COPD). Drugs with antioxidant and anti-inflammatory properties, such as N-acetylcysteine, might provide a useful therapeutic approach for COPD. We aimed to assess whether N-acetylcysteine could reduce the rate of exacerbations in patients with COPD. Methods: In our prospective, randomised, double-blind, placebo-controlled, parallel-group study, we enrolled patients aged 40-80 years with moderate-to-severe COPD (post-bronchodilator forced expiratory volume in 1 s [FEV1]/forced vital capacity <0·7 and FEV1 of 30-70% of predicted) at 34 hospitals in China. We stratified patients according to use of inhaled corticosteroids (regular use or not) at baseline and randomly allocated them to receive N-acetylcysteine (one 600 mg tablet, twice daily) or matched placebo for 1 year. The primary endpoint was the annual exacerbation rate in patients who received at least one dose of study drug and had at least one assessment visit after randomisation. This study is registered with the Chinese Clinical Trials Registry, ChiCTR-TRC-09000460. Findings: Between June 25, 2009, and Dec 29, 2010, we screened 1297 patients, of whom 1006 were eligible for randomisation (504 to N-acetylcysteine and 502 to placebo). After 1 year, we noted 497 acute exacerbations in 482 patients in the N-acetylcysteine group who received at least one dose and had at least one assessment visit (1·16 exacerbations per patient-year) and 641 acute exacerbations in 482 patients in the placebo group (1·49 exacerbations per patient-year; risk ratio 0·78, 95% CI 0·67-0·90; p=0·0011). N-acetylcysteine was well tolerated: 146 (29%) of 495 patients who received at least one dose of N-acetylcysteine had adverse events (48 serious), as did 130 (26%) of 495 patients who received at least one dose of placebo (46 serious). The most common serious adverse event was acute exacerbation of COPD, occurring in 32 (6%) of 495 patients in the N-acetylcysteine group and 36 (7%) of 495 patients in the placebo group. Interpretation: Our findings show that in Chinese patients with moderate-to-severe COPD, long-term use of N-acetylcysteine 600 mg twice daily can prevent exacerbations, especially in disease of moderate severity. Future studies are needed to explore efficacy in patients with mild COPD (GOLD I). Funding: Hainan Zambon Pharmaceutical.

相关科学

医学
肺和呼吸医学

文献指纹

医学与生命科学

Acetylcysteine

Chronic Obstructive Pulmonary Disease

Placebos

Forced Expiratory Volume

Random Allocation

Pharmaceutical Preparations

Bronchodilator Agents

Vital Capacity

Tablets

China

Adrenal Cortex Hormones

Registries

Antioxidants

Oxidative Stress

Anti-Inflammatory Agents

Clinical Trials

Odds Ratio

Inflammation

Therapeutics

被引量

期刊度量

Scopus度量

年份 CiteScore SJR SNIP
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013 2.6
2014 7.2 3.121 3.202
2015 14.9 5.499 4.828
2016 23.7 6.415 5.103
2017 27.3 7.746 5.746
2018 27.2 7.695 6.346
2019 27.6 7.516 6.666
2020 41.7
2021

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