Clinical Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis_Chinese Journal of Respiratory and Critical Care Medicine

Authors：

 LiHuiping ¹ , WangSiqin ² , ZhouJianying ³ , WanHuanyin ⁴ , WangLimin ⁵ , WangGuangfa ⁶ , YinZengji ⁷

1. Department of Respiratory Medicine, Shanghai Pulmonary Hospital, Tongji University, School of Medicine, Shanghai, 200433, China;
2. ;
3. ;
4. ;
5. ;
6. ;
7. ;

Corresponding author：

LiHuiping, Email: liw2013@126.com

Keywords：

Idiopathic pulmonary fibrosis; Pirfenidone

DOI：

10.7507/1671-6205.2015059

Video：

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Objective To evaluate the clinical efficacy and safety of pirfenidone in Chinese patients with idiopathic pulmonary fibrosis (IPF). Methods In a multicenter,randomized,double-blind,comparative clinical trial,87 patients with IPF were randomly divided into two groups. Group A (43 patients) were treated with pirfenidone (1 200 mg per day) for 48 weeks,while Group B (44 patients) were treated with placebo. Clinical features were compared between two groups including efficacy indicators (pulmonary function,6MWT,and quality of life scores) and safety indicators (incidence of adverse events). Results Forced vital capacity (FVC) was increased by (90±410)mL in Group A and decreased by (70±310)mL in Group B (P<0.05);In Group A,forced expiratory volume in 1 second was raised by (100±330)mL and (110±240)mL following 12 and 24 weeks after treatment,significantly different from group B (P<0.05). There were significant differences in 6MWT between two groups 36 and 48 weeks after treatment respectively(both P<0.05). Quality of life scores,including the St. George's score (excluding symptoms) and dyspnea score,were significantly higher in Group A than Group B (both P<0.05). There was no significant difference in the incidence of adverse events between Groups A and B (83.72% vs. 72.73%,P>0.05). Conclusion Domestic pirfenidone is clinically effective and safe for the treatment of IPF in Chinese patients.

Citation： LiHuiping, WangSiqin, ZhouJianying, WanHuanyin, WangLimin, WangGuangfa, YinZengji. Clinical Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. Chinese Journal of Respiratory and Critical Care Medicine, 2015, 14(3): 229-235. doi: 10.7507/1671-6205.2015059 Copy

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4.	King TE Jr,Bradford WZ,Castro-Bernardini S,et al. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med,2014,370:2083-2092.
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6.	Liu Y. Hepatocyte growth factor in kidney fibrosis:therapeutic potential and mechanisms of action. Am J Physiol Renal Physiol,2004,287:F7-F16.
7.	Navarro-Partida J,Martinez-Rizo AB,Gonzalez-Cuevas J,et al. Pirfenidone restricts Th2 differentiation in vitro and limits Th2 response in experimental liver fibrosis. Eur J Pharmacol,2012,678:71-77.
8.	Suga H,Teraoka S,Ota K,et al. Preventive effect of pirfenidone against experimental sclerosing peritonitis in rats. Exp Toxicol Pathol,1995,47:287-291.
9.	Hisatomi K,Mukae H,Sakamoto N,et al. Pirfenidone inhibits TGF-beta1-induced over-expression of collagen type Ⅰ and heat shock protein 47 in A549 cells. BMC Pulm Med,2012,12:24.
10.	Shi Q,Liu X,Bai Y,et al. In vitro effects of pirfenidone on cardiac fibroblasts:proliferation,myofibroblast differentiation,migration and cytokine secretion. PLoS One,2011,6:e28134.
11.	Noble PW,Albera C,Bradford WZ,et al. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY):two randomised trials. Lancet,2011,377:1760-1769.
12.	Travis WD,Costabel U,Hansell DM,et al. An official American Thoracic Society/European Respiratory Society statement:Update of the international multidisciplinary classification of the idiopathic interstitial pneumonias. Am J Respir Crit Care Med,2013,188:733-748.
13.	Taniguchi H,Ebina M,Kondoh Y,et al. Pirfenidone in idiopathic pulmonary fibrosis. Eur Respir J,2010,35:821-829.

1. Vancheri C,Failla M,Crimi N,et al. Idiopathic pulmonary fibrosis:a disease with similarities and links to cancer biology. Eur Respir J,2010,35:496-504.
2. Azuma A,Nukiwa T,Tsuboi E,et al. Double-blind,placebo-controlled trial of pirfenidone in patients with idiopathic pulmonary fibrosis. Am J Respir Crit Care Med,2005,171:1040-1047.
3. Pecci A,Biino G,Fierro T,et al. Alteration of liver enzymes is a feature of the MYH9-related disease syndrome. PLoS One,2012,7:e35986.
4. King TE Jr,Bradford WZ,Castro-Bernardini S,et al. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med,2014,370:2083-2092.
5. Luppi F,Spagnolo P,Cerri S,et al. The big clinical trials in idiopathic pulmonary fibrosis. Curr Opin Pulm Med,2012,18:428-432.
6. Liu Y. Hepatocyte growth factor in kidney fibrosis:therapeutic potential and mechanisms of action. Am J Physiol Renal Physiol,2004,287:F7-F16.
7. Navarro-Partida J,Martinez-Rizo AB,Gonzalez-Cuevas J,et al. Pirfenidone restricts Th2 differentiation in vitro and limits Th2 response in experimental liver fibrosis. Eur J Pharmacol,2012,678:71-77.
8. Suga H,Teraoka S,Ota K,et al. Preventive effect of pirfenidone against experimental sclerosing peritonitis in rats. Exp Toxicol Pathol,1995,47:287-291.
9. Hisatomi K,Mukae H,Sakamoto N,et al. Pirfenidone inhibits TGF-beta1-induced over-expression of collagen type Ⅰ and heat shock protein 47 in A549 cells. BMC Pulm Med,2012,12:24.
10. Shi Q,Liu X,Bai Y,et al. In vitro effects of pirfenidone on cardiac fibroblasts:proliferation,myofibroblast differentiation,migration and cytokine secretion. PLoS One,2011,6:e28134.
11. Noble PW,Albera C,Bradford WZ,et al. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY):two randomised trials. Lancet,2011,377:1760-1769.
12. Travis WD,Costabel U,Hansell DM,et al. An official American Thoracic Society/European Respiratory Society statement:Update of the international multidisciplinary classification of the idiopathic interstitial pneumonias. Am J Respir Crit Care Med,2013,188:733-748.
13. Taniguchi H,Ebina M,Kondoh Y,et al. Pirfenidone in idiopathic pulmonary fibrosis. Eur Respir J,2010,35:821-829.

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Clinical Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis

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