Safety of pirfenidone in treatment of idiopathic pulmonary fibrosis:a Meta-analysis
10.3760/cma.j.issn.1008-5734.2015.03.009
- VernacularTitle:吡非尼酮治疗特发性肺间质纤维化安全性Meta分析
- Author:
Zhihong FENG
1
;
Bing WEI
1
;
Guojie TENG
1
;
Chunni YU
1
;
Kui REN
1
;
Shang GAO
1
;
Xiuhong NIE
1
Author Information
1. 首都医科大学宣武医院呼吸科,北京,100053
- Publication Type:Journal Article
- Keywords:
Pirfenidone;
Idiopathic pulmonary fibrosis;
Safety;
Meta-analysis
- From:
Adverse Drug Reactions Journal
2015;(3):196-203
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the safety of pirfenidone in treatment of idiopathic pulmonary fibrosis( IPF). Methods PubMed,the Cochrane library,EMbase,CNKI,and WanFang database were searched using the keywords pirfenidone,idiopathic pulmonary fibrosis,and IPF from January 1999 to January 2015. Randomized controlled trials( RCTs)of pirfenidone in treatment of IPF were selected. The patients in the trial group were given pirfenidone alone while the patients in the control group were given oral placebo. The primary end point event of the outcome was the incidence of pirfenidone′s adverse events. The Meta-analysis was performed using RevMan 5. 2. Results A total of 4 articles including 5 RCTs were enrolled. There were 945 patients in the trial group and 766 patients in the control group. The incidents of many kinds of adverse events in the trial group were markedly higher than those in the control group, including gastrointestinal discomfort[12. 6%(101/804)vs. 5. 2%(40/766),RR = 2. 31,95% CI:63-3. 29,P< 0. 01],nausea[34. 6%(241/695)vs. 15. 0%(99/659),RR = 2. 373,95% CI:1. 92-2. 92,P< 0. 01]and vomiting[13. 3%(83/623)vs. 6. 3%(39/624),RR= 2. 13,95% CI:1. 48-3. 06,P< 0. 01],diarrhea[25. 8%(161/623)vs. 20. 4%(127/624),RR= 1. 27,95% CI:1. 03-1. 56,P=0. 02],anorexia[15. 2%(122/804)vs. 4. 7%(36/766),RR= 3. 10,95% CI:2. 16-4. 46,P<0. 01],abnormal liver function[6. 0%(49/804)vs. 1. 7%(13/766),RR= 2. 48,95% CI:1. 46-4. 23,P<0. 01],rash[30. 4%(189/623)vs. 10. 3%(64/624),RR= 2. 95,95% CI:2. 27-3. 83,P<0. 01],photosensitivity reaction[24. 7%(129/526)vs. 6. 1%(30/489),RR= 5. 54,95%CI:1. 78-17. 30,P<0. 01],insomnia[10. 4%(65/623)vs. 6. 6%(41/624),RR=1. 59,95% CI:1. 09-2. 31,P= 0. 02],dizziness[16. 4%(120/732)vs. 9. 8%(72/731),RR=1. 67,95% CI:1. 27-2. 19,P<0. 01],fatigue[25. 6%(178/695)vs. 16. 3%(108/659),RR = 1. 60,95% CI:1. 29-1. 98,P< 0. 01],and weight loss[10. 1%(63/623)vs. 5. 4%(34/624),RR= 1. 85,95% CI:1. 24-2. 77,P = 0. 03]. However,there was no statistically significant difference in treatment-related serious events[26. 5%(165/623)vs. 26. 4%(165/624),RR = 1. 00,95% CI:0. 83-1. 20,P = 0. 94]. Compared with the control group,there was a statistical significance in the rate of drug withdrawal in the trial group[14. 6%( 117/804 ) vs. 9. 0%( 69/766 ),RR = 1. 62,95% CI:1. 22-2. 15,P <0. 01 ). Conclusion The common adverse events of pirfenidone are gastrointestinal,skin,and neurological system damage and fatigue and loss of weight. The adverse events are mild and mostly recoverable without obvious sequelae. The pirfenidone is safe and well-tolerated.
