Adverse events of pirfenidone for the treatment of pulmonary fibrosis: a meta-analysis of randomized controlled trials.
Adverse events of pirfenidone for the treatment of pulmonary fibrosis: a meta-analysis of randomized controlled trials.
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吡非尼酮治疗肺纤维化的不良事件：随机对照试验的荟萃分析
DOI：
10.1371/journal.pone.0047024
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发表时间：
2012
期刊：
影响因子：
3.7
通讯作者：
Xu Z
中科院分区：
文献类型：
--
作者：
Jiang C;Huang H;Liu J;Wang Y;Lu Z;Xu Z
背景 吡非尼酮（PFD）是一种新型抗纤维化药物，被批准用于肺纤维化患者。然而，人们担心该药物的毒性。在这项荟萃分析中，我们分析了 PFD 治疗肺纤维化的不良事件 (AE)。方法 我们对 PubMed、Embase、ClinicalTrials.gov 和 Cochrane 对照试验中央注册库进行了系统检索，查找 1999 年 1 月至 2011 年 10 月期间发表的试验。使用 Review manager 5.0.24 分析从文献中提取的数据。结果六项随机对照试验（1073 名受试者）的结果显示，停止 PFD 治疗的人数显着高于接受安慰剂的患者人数。与安慰剂组相比，PFD 组的胃肠道（恶心、消化不良、腹泻和厌食）、神经系统（头晕和疲劳）和皮肤病（光敏性和皮疹）AE 发生率显着较高。结论 PFD用于治疗肺纤维化的安全性或耐受性较差。值得注意的是，接受 PFD 治疗的患者中胃肠道、神经系统和皮肤病学不良反应更为常见，因此需要采取适当的预防措施。
Background Pirfenidone (PFD) is a novel antifibrotic agent approved for patients with pulmonary fibrosis. However, there are concerns regarding toxicity of the drug. In this meta-analysis, we analyzed the adverse events (AEs) of PFD for the treatment of pulmonary fibrosis. Methods We performed a systematic search of PubMed, Embase, ClinicalTrials.gov, and Cochrane Central Register of Controlled Trials for trials published between January 1999 and October 2011. Data extracted from literature were analyzed with Review manager 5.0.24. Results The results of six randomized controlled trials (1073 participants) revealed that the number of individuals who discontinued PFD therapy was significantly higher than patients receiving placebo. The PFD group had a significantly higher rate of gastrointestinal (nausea, dyspepsia, diarrhea, and anorexia), neurological (dizziness and fatigue), and dermatological (photosensitivity and rash) AEs compared to the placebo group. Conclusions PFD used for the treatment of pulmonary fibrosis is not so safe or well-tolerated. Notably, gastrointestinal, neurological and dermatological adverse effects were more common in patients receiving PFD therapy, and therefore appropriate precaution is needed.
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影响因子：
3.8
作者：
O'Brien, Kevin;Troendle, James;Gochuico, Bernadette R.;Markello, Thomas C.;Salas, Jose;Cardona, Hilda;Yao, Jianhua;Bernardini, Isa;Hess, Richard;Gahl, William A.
通讯作者：
Gahl, William A.
DOI：
10.1164/ajrccm.159.4.9805017
发表时间：
1999-04-01
影响因子：
24.7
作者：
Raghu, G;Johnson, WC;Mageto, Y
通讯作者：
Mageto, Y
DOI：
10.1164/rccm.200709-1446oc
发表时间：
2008-11-01
影响因子：
24.7
作者：
Raghu, Ganesh;Brown, Kevin K.;Fatenejad, Saeed
通讯作者：
Fatenejad, Saeed
DOI：
10.1164/rccm.200602-163oc
发表时间：
2006-10-01
影响因子：
24.7
作者：
Raghu, Ganesh;Weycker, Derek;Oster, Gerry
通讯作者：
Oster, Gerry
影响因子：
3.2
作者：
Rubino, C. M.;Bhavnani, S. M.;Loutit, J. S.
通讯作者：
Loutit, J. S.