What we learn from the clinical trials of chronic obstructive pulmonary disease_Chinese Journal of Respiratory and Critical Care Medicine

Authors：

LIU Chuntao

Department of Respiratory Medicine, West China Hospital, Sichuan University. Chengdu, Sichuan, 610041, China;

Corresponding author：

Keywords：

慢性阻塞性肺疾病; 临床试验

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直到10年前，慢性阻塞性肺疾病(COPD)还被认为是一种持续进展、不可逆的疾病，一个疗效堪忧、前景暗淡、回报甚微的疾病[1]，正因为如此，很少开展COPD的治疗性试验。最近l0年以来在世界上的大部分国家和地区COPD已构成主要的疾病负担之一[2,3]，带来的直接和间接成本不断增加，促使各国政府和医药企业增加了对COPD临床试验的投入，一系列大型国际多中心临床试验的结果，使我们对COPD知之不多甚至一无所知的侧面有了新的认识，改变了我们固有的观念，并勾勒出COPD未来的前景。在这一领域，中国呼吸病学T作者贡献不多，自主开展的COPD多中心临床试验寥寥无几。回顾上个世纪70年代以来COPD临床试验的历程，无疑对我们有极大的启示作用。

Citation： LIU Chuntao. What we learn from the clinical trials of chronic obstructive pulmonary disease. Chinese Journal of Respiratory and Critical Care Medicine, 2007, 6(6): 405-409. doi: Copy

1.	Fletcher CM，Pride NB.Definitions of emphysema，chronic bronchitis，asthma，and airflow obstruction：25 years on from the Ciba symposium.Thorax，1984，39：81-85.
2.	Rabe KF，Hurd S，Anzueto A，et al.Global strategy for the diagnosis，management，and prevention of chronic obstructive pulmonary disease：GOLD executive summary.Am J Respir Crit Care Med，2007，176：532-555.
3.	Chapman KR，Mannino DM，Soriano JB，et al.Epidemiology and costs of chronic obstructive pulmonary disease.Eur Respir J，2006，27：188-207.
4.	Anthonisen NR，Skeans MA，Wise RA，et al.The effects of a smoking cessation intervention on 14.5-year mortality：a randomized clinical trial.Ann Intern Med，2005，142：233-239.
5.	Anthonisen NR，Manfreda J，Warren CP，et al.Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease.Ann Intern Med，1987，106：196-204.
6.	Celli BR，MacNee W.ATS/ERS Task Force.Standards for the diagnosis and treatment of patients with COPD：a summary of the ATS/ERS position paper.Eur Respir J，2004，23：932-946.
7.	Calverley PM，Spencer S，Willits L，et al.Withdrawal from treatment as an outcome in the ISOLDE study of COPD.Chest，2003，124：1350-1356.
8.	Decramer M，Rutten-van Mölken M，Dekhuijzen PN，et al.Effects of N-acetylcysteine on outcomes in chronic obstructive pulmonary disease（Bronchitis Randomized on NAC Cost-Utility Study，BRONCUS）：a randomised placebo-controlled trial.Lancet，2005，365：1552-1560.
9.	Calverley PM，Anderson JA，Celli B，et al.Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.N Engl J Med，2007，356：775-789.
10.	Celli B，Ferguson GT，Anderson JA，et al.Salmeterol/Fluticasone propionate（SFC） improves lung function and reduces rate of decline over three years in the TORCH survival study.Proc Am Thorac Soc，2007，4：A763.
11.	O’Donnell DE，Flüge T，Gerken F，et al.Effects of tiotropium on lung hyperinflation，dyspnoea and exercise tolerance in COPD.Eur Respir J，2004，23：832-840.
12.	Szafranski W，Cukier A，Ramirez A，et al.Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease.Eur Respir J，2003，21：74-81.
13.	Vestbo J，Sorensen T，Lange P，et al.Long-term effect of inhaled budesonide in mild and moderate chronic obstructive pulmonary disease：a randomised controlled trial.Lancet，1999，353：1819-1823.
14.	Hattotuwa KL，Gizycki MJ，Ansari TW，et al.The effects of inhaled fluticasone on airway inflammation in chronic obstructive pulmonary disease：a double-blind，placebo-controlled biopsy study.Am J Respir Crit Care Med，2002，165：1592-1596.
15.	Fishman A，Martinez F，Naunheim K，et al.A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema.N Engl J Med，2003，348：2059-2073.
16.	Aaron SD，Vandemheen KL，Fergusson D，et al.Tiotropium in combination with placebo，salmeterol，or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease：a randomized trial.Ann Intern Med，2007，146：545-555.
17.	Rabe KF，Bateman ED，O’Donnell D，et al.Roflumilast--an oral anti-inflammatory treatment for chronic obstructive pulmonary disease：a randomised controlled trial.Lancet，2005，366：563-571.
18.	Rennard SI，Fogarty C，Kelsen S，et al.The safety and efficacy of infliximab in moderate to severe chronic obstructive pulmonary disease.Am J Respir Crit Care Med，2007，175：926-934.

1. Fletcher CM，Pride NB.Definitions of emphysema，chronic bronchitis，asthma，and airflow obstruction：25 years on from the Ciba symposium.Thorax，1984，39：81-85.
2. Rabe KF，Hurd S，Anzueto A，et al.Global strategy for the diagnosis，management，and prevention of chronic obstructive pulmonary disease：GOLD executive summary.Am J Respir Crit Care Med，2007，176：532-555.
3. Chapman KR，Mannino DM，Soriano JB，et al.Epidemiology and costs of chronic obstructive pulmonary disease.Eur Respir J，2006，27：188-207.
4. Anthonisen NR，Skeans MA，Wise RA，et al.The effects of a smoking cessation intervention on 14.5-year mortality：a randomized clinical trial.Ann Intern Med，2005，142：233-239.
5. Anthonisen NR，Manfreda J，Warren CP，et al.Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease.Ann Intern Med，1987，106：196-204.
6. Celli BR，MacNee W.ATS/ERS Task Force.Standards for the diagnosis and treatment of patients with COPD：a summary of the ATS/ERS position paper.Eur Respir J，2004，23：932-946.
7. Calverley PM，Spencer S，Willits L，et al.Withdrawal from treatment as an outcome in the ISOLDE study of COPD.Chest，2003，124：1350-1356.
8. Decramer M，Rutten-van Mölken M，Dekhuijzen PN，et al.Effects of N-acetylcysteine on outcomes in chronic obstructive pulmonary disease（Bronchitis Randomized on NAC Cost-Utility Study，BRONCUS）：a randomised placebo-controlled trial.Lancet，2005，365：1552-1560.
9. Calverley PM，Anderson JA，Celli B，et al.Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.N Engl J Med，2007，356：775-789.
10. Celli B，Ferguson GT，Anderson JA，et al.Salmeterol/Fluticasone propionate（SFC） improves lung function and reduces rate of decline over three years in the TORCH survival study.Proc Am Thorac Soc，2007，4：A763.
11. O’Donnell DE，Flüge T，Gerken F，et al.Effects of tiotropium on lung hyperinflation，dyspnoea and exercise tolerance in COPD.Eur Respir J，2004，23：832-840.
12. Szafranski W，Cukier A，Ramirez A，et al.Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease.Eur Respir J，2003，21：74-81.
13. Vestbo J，Sorensen T，Lange P，et al.Long-term effect of inhaled budesonide in mild and moderate chronic obstructive pulmonary disease：a randomised controlled trial.Lancet，1999，353：1819-1823.
14. Hattotuwa KL，Gizycki MJ，Ansari TW，et al.The effects of inhaled fluticasone on airway inflammation in chronic obstructive pulmonary disease：a double-blind，placebo-controlled biopsy study.Am J Respir Crit Care Med，2002，165：1592-1596.
15. Fishman A，Martinez F，Naunheim K，et al.A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema.N Engl J Med，2003，348：2059-2073.
16. Aaron SD，Vandemheen KL，Fergusson D，et al.Tiotropium in combination with placebo，salmeterol，or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease：a randomized trial.Ann Intern Med，2007，146：545-555.
17. Rabe KF，Bateman ED，O’Donnell D，et al.Roflumilast--an oral anti-inflammatory treatment for chronic obstructive pulmonary disease：a randomised controlled trial.Lancet，2005，366：563-571.
18. Rennard SI，Fogarty C，Kelsen S，et al.The safety and efficacy of infliximab in moderate to severe chronic obstructive pulmonary disease.Am J Respir Crit Care Med，2007，175：926-934.

Chinese Journal of Respiratory and Critical Care Medicine

What we learn from the clinical trials of chronic obstructive pulmonary disease

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