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; 臨床試驗

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直到10年前，慢性阻塞性肺疾病(COPD)還被認為是一種持續進展、不可逆的疾病，一個療效堪憂、前景暗淡、回報甚微的疾病[1]，正因為如此，很少開展COPD的治療性試驗。最近l0年以來在世界上的大部分國家和地區COPD已構成主要的疾病負擔之一[2,3]，帶來的直接和間接成本不斷增加，促使各國政府和醫藥企業增加了對COPD臨床試驗的投入，一系列大型國際多中心臨床試驗的結果，使我們對COPD知之不多甚至一無所知的側面有了新的認識，改變了我們固有的觀念，并勾勒出COPD未來的前景。在這一領域，中國呼吸病學T作者貢獻不多，自主開展的COPD多中心臨床試驗寥寥無幾。回顧上個世紀70年代以來COPD臨床試驗的歷程，無疑對我們有極大的啟示作用。

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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