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:
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Copyright © the editorial department of Chinese Journal of Respiratory and Critical Care Medicine of West China Medical Publisher. All rights reserved
| 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.
