|Twice daily N-acetylcysteine 600 mg for exacerbations of chronic obstructive pulmonary disease (PANTHEON): a randomised, double-blind placebo-controlled trial|
|Zheng, Jin-Ping1; Wen, Fu-Qiang2; Bai, Chun-Xue3; Wan, Huan-Ying4; Kang, Jian5; Chen, Ping6; Yao, Wan-Zhen7; Ma, Li-Jun8; Li, Xia9; Raiteri, Luca10; Sardina, Marco10; Gao, Yi1; Wang, Bai-Song11; Zhong, Nan-Shan1; PANTHEON Study Grp|
|刊名||LANCET RESPIRATORY MEDICINE|
|WOS标题词||Science & Technology|
|关键词[WOS]||FLUTICASONE PROPIONATE ; CHINESE PATIENTS ; COPD ; EFFICACY ; SALMETEROL ; CARBOCISTEINE ; SAFETY ; 1-YEAR|
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).
|资助机构||Hainan Zambon Pharmaceutical|
|作者单位||1.Peking Univ, Hosp 3, Beijing 100871, Peoples R China|
2.Henan Prov Peoples Hosp, Zhengzhou, Peoples R China
3.Hainan Zambon Pharmaceut, Beijing, Peoples R China
4.Zambon, Innovat & Med Sci Dept, Milan, Italy
5.MedKey Med Tec Dev, Shanghai, Peoples R China
6.Shenyang PLA Gen Hosp, Shenyang, Peoples R China
7.Guangzhou Med Univ, Affiliated Hosp 1, Natl Clin Res Ctr Resp Dis, State Key Lab Resp Dis,Guangzhou Inst Resp Dis, Guangzhou, Guangdong, Peoples R China
8.Sichuan Univ, West China Hosp, Chengdu 610064, Peoples R China
9.Fudan Univ, Zhongshan Hosp, Shanghai 200433, Peoples R China
10.China Med Univ, Affiliated Hosp 1, Shenyang, Peoples R China
11.Shanghai Jiao Tong Univ, Sch Med, Rui Jin Hosp, Shanghai 200030, Peoples R China
|Zheng, Jin-Ping,Wen, Fu-Qiang,Bai, Chun-Xue,et al. Twice daily N-acetylcysteine 600 mg for exacerbations of chronic obstructive pulmonary disease (PANTHEON): a randomised, double-blind placebo-controlled trial[J]. LANCET RESPIRATORY MEDICINE,2014,2(3):187-194.|
|APA||Zheng, Jin-Ping.,Wen, Fu-Qiang.,Bai, Chun-Xue.,Wan, Huan-Ying.,Kang, Jian.,...&PANTHEON Study Grp.(2014).Twice daily N-acetylcysteine 600 mg for exacerbations of chronic obstructive pulmonary disease (PANTHEON): a randomised, double-blind placebo-controlled trial.LANCET RESPIRATORY MEDICINE,2(3),187-194.|
|MLA||Zheng, Jin-Ping,et al."Twice daily N-acetylcysteine 600 mg for exacerbations of chronic obstructive pulmonary disease (PANTHEON): a randomised, double-blind placebo-controlled trial".LANCET RESPIRATORY MEDICINE 2.3(2014):187-194.|