吡非尼酮治疗特发性肺纤维化: 我们拥有多少证据?_Chinese Journal of Respiratory and Critical Care Medicine

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孙渊蔡后荣 ¹

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吡非尼酮; 特发性肺纤维化

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特发性肺纤维化( idiopathic pulmonary fibrosis, IPF) 为原因不明, 局限于肺, 以普通型间质性肺炎( usual interstitialpneumonitis, UIP) 为病理特征的慢性进行性发展的纤维化性间质性肺疾病。该病预后不良, 现无有效治疗药物[1] , 寻找有效治疗IPF的药物始终是该研究领域的热点之一。迄今已有诸多针对肺纤维化发病机制的基础研究成果, 并陆续转化为新的研究药物[2] 。IPF 临床中心协作网的建立使数以百计的IPF患者比较快地入组参加新药物临床试验, 并顺利完成了多项高质量的双盲、随机、安慰剂对照临床试验, 有力推动了IPF 治疗领域的进展。遗憾的是, 近几年已发表的多项临床试验结果[3-6] 令人失望。在挫折和期盼之中, 最新发表的吡非尼酮( pirfenidone) 治疗IPF临床试验结果[7] 为无药可治的IPF患者带来了一线希望的曙光。

Citation： 孙渊蔡后荣. 吡非尼酮治疗特发性肺纤维化: 我们拥有多少证据?. Chinese Journal of Respiratory and Critical Care Medicine, 2010, 9(5): 456-457. doi: Copy

1.	American Thoracic Society/ European Respiratory Society. American Thoracic Society /European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias. Am J Respir Crit Care Med, 2002, 165 : 277-304 .
2.	du Bois RM. Strategies for treating idiopathic pulmonary fibrosis. Nat Rev Drug Discov, 2010 , 9: 129-140 .
3.	Daniels CE, Lasky JA, Limper AH, et al. Imatinib treatment for idiopathic pulmonary fibrosis: Randomized placebo-controlled trial results. Am J Respir Crit Care Med, 2010, 181 : 604-610.
4.	King TE Jr, Albera C, Bradford WZ, et al. Effect of interferon gamma-1b on survival in patients with idiopathic pulmonary fibrosis ( INSPIRE) : a multicentre, randomised, placebo-controlled trial.Lancet, 2009, 374 : 222-228.
5.	King TE Jr, Behr J, Brown KK, et al. BUILD-1 : a randomized placebo-controlled trial of bosentan in idiopathic pulmonary fibrosis.Am J Respir Crit Care Med, 2008, 177: 75-81.
6.	Raghu G, Brown KK, Costabel U, et al. Treatment of idiopathic pulmonary fibrosis with etanercept: an exploratory, placebocontrolled trial. Am J Respir Crit Care Med, 2008, 178: 948 -955.
7.	Taniguchi H, Ebina M, Kondoh Y, et al. Pirfenidone in idiopathic pulmonary fibrosis. Eur Respir J, 2010, 35: 821-829.
8.	Raghu G, Johnson WC, Lockhart D, et al. Treatment of idiopathic pulmonary fibrosis with a new antifibrotic agent, pirfenidone: results of a prospective, open-label phase II study. Am J Respir Crit Care Med, 1999, 159: 1061-1069.
9.	Azuma A, Nukiwa T, Tsuboi E, et al. Double-blind, placebocontrolled trial of pirfenidone in patients with idiopathic pulmonary fibrosis. Am J Respir Crit Care Med, 2005, 171: 1040 -1047 .
10.	Collard HR. Idiopathic pulmonary fibrosis and pirfenidone. Eur Respir J, 2010, 35 : 728-729.
11.	King TE Jr, Safrin S, Starko KM, et al. Analyses of efficacy end points in a controlled trial of interferon-γ1 b for idiopathic pulmonary fibrosis. Chest, 2005, 127: 171 -177.
12.	Liu G, Gould AL. Comparison of alternative strategies for analysis of longitudinal trials with dropouts. J Biopharm Stat, 2002,12:207-226.
13.	Swigris JJ, Brown KK, Behr J, et al. The SF-36 and SGRQ: validity and first look at minimumimportant differences in IPF. Respir Med,2010, 104: 296-304.
14.	InterMune. Investor Relations. Available from: http: / /phx.corporate-ir. net/ phoenix. zhtml? c = 100067&p = irol-IRHome .Date last accessed:May 17, 2010 .

1. American Thoracic Society/ European Respiratory Society. American Thoracic Society /European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias. Am J Respir Crit Care Med, 2002, 165 : 277-304 .
2. du Bois RM. Strategies for treating idiopathic pulmonary fibrosis. Nat Rev Drug Discov, 2010 , 9: 129-140 .
3. Daniels CE, Lasky JA, Limper AH, et al. Imatinib treatment for idiopathic pulmonary fibrosis: Randomized placebo-controlled trial results. Am J Respir Crit Care Med, 2010, 181 : 604-610.
4. King TE Jr, Albera C, Bradford WZ, et al. Effect of interferon gamma-1b on survival in patients with idiopathic pulmonary fibrosis ( INSPIRE) : a multicentre, randomised, placebo-controlled trial.Lancet, 2009, 374 : 222-228.
5. King TE Jr, Behr J, Brown KK, et al. BUILD-1 : a randomized placebo-controlled trial of bosentan in idiopathic pulmonary fibrosis.Am J Respir Crit Care Med, 2008, 177: 75-81.
6. Raghu G, Brown KK, Costabel U, et al. Treatment of idiopathic pulmonary fibrosis with etanercept: an exploratory, placebocontrolled trial. Am J Respir Crit Care Med, 2008, 178: 948 -955.
7. Taniguchi H, Ebina M, Kondoh Y, et al. Pirfenidone in idiopathic pulmonary fibrosis. Eur Respir J, 2010, 35: 821-829.
8. Raghu G, Johnson WC, Lockhart D, et al. Treatment of idiopathic pulmonary fibrosis with a new antifibrotic agent, pirfenidone: results of a prospective, open-label phase II study. Am J Respir Crit Care Med, 1999, 159: 1061-1069.
9. Azuma A, Nukiwa T, Tsuboi E, et al. Double-blind, placebocontrolled trial of pirfenidone in patients with idiopathic pulmonary fibrosis. Am J Respir Crit Care Med, 2005, 171: 1040 -1047 .
10. Collard HR. Idiopathic pulmonary fibrosis and pirfenidone. Eur Respir J, 2010, 35 : 728-729.
11. King TE Jr, Safrin S, Starko KM, et al. Analyses of efficacy end points in a controlled trial of interferon-γ1 b for idiopathic pulmonary fibrosis. Chest, 2005, 127: 171 -177.
12. Liu G, Gould AL. Comparison of alternative strategies for analysis of longitudinal trials with dropouts. J Biopharm Stat, 2002,12:207-226.
13. Swigris JJ, Brown KK, Behr J, et al. The SF-36 and SGRQ: validity and first look at minimumimportant differences in IPF. Respir Med,2010, 104: 296-304.
14. InterMune. Investor Relations. Available from: http: / /phx.corporate-ir. net/ phoenix. zhtml? c = 100067&p = irol-IRHome .Date last accessed:May 17, 2010 .

Chinese Journal of Respiratory and Critical Care Medicine

吡非尼酮治疗特发性肺纤维化: 我们拥有多少证据?

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