Department of Respiratory Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
PLoS One. 2012;7(10):e47024. doi: 10.1371/journal.pone.0047024. Epub 2012 Oct 9.
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.
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.
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.
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.
吡非尼酮（PFD）是一种新型抗纤维化药物，已被批准用于治疗肺纤维化患者。然而，人们对该药物的毒性存在担忧。在这项荟萃分析中，我们分析了吡非尼酮治疗肺纤维化的不良反应（AE）。
我们对 1999 年 1 月至 2011 年 10 月期间发表的文献进行了系统的检索，包括 PubMed、Embase、ClinicalTrials.gov 和 Cochrane 中央对照试验注册库。使用 Review Manager 5.0.24 分析从文献中提取的数据。
六项随机对照试验（1073 名参与者）的结果表明，停止使用吡非尼酮治疗的人数明显高于接受安慰剂的患者。与安慰剂组相比，PFD 组胃肠道（恶心、消化不良、腹泻和厌食）、神经（头晕和疲劳）和皮肤（光敏性和皮疹）不良反应的发生率明显更高。
吡非尼酮用于治疗肺纤维化并不安全或耐受良好。值得注意的是，接受 PFD 治疗的患者更常出现胃肠道、神经和皮肤不良反应，因此需要适当预防。
