Ren Hui, Wang Kai, Yang Hao, Gao Lingyun
Department of Outpatients, Sichuan Academy of Medical Sciences＆Sichuan Provincial People's Hospital , Chengdu, Sichuan Province, China. E-mail.
Saudi Med J. 2017 Sep;38(9):889-894. doi: 10.15537/smj.2017.9.19349.
To analyze the efficacy and adverse events (AEs) of pirfenidone in idiopathic pulmonary fibrosis (IPF) trials. Methods: MEDLINE, Cochrane Library, and ClinicalTrials.gov were searched for studies published before June 2016. All studies of clinical trials with the key words IPF or idiopathic pulmonary fibrosis or lung fibrosis and pirfenidone or Esbriet were identified. Quality assessment and data extraction nwere conducted by 2 independent researchers. A meta-analysis of randomized controlled trials (RCTs) was performed, and relative risk (RR) and 95% confidence intervals (95% CIs) were calculated. Results: Five studies were included in this review, involving 1568 participants. The meta-analysis revealed that pirfenidone reduced the risk of decline in forced vital capacity (FVC)% ≥10% from baseline (relative risk: 0.62; 95% CI: 0.51-0.76, p less than 0.001). The pirfenidone group had a significantly higher rate of AEs compared with the placebo group. Pirfenidone did not reduce mortality from any cause significantly (odds ratio: 0.63; 95% CI: 0.36-1.09). Conclusions: This study showed that pirfenidone could reduce disease progression as assessed by the decline in FVC in IPF. Pirfenidone represents a suitable treatment option for patients with IPF.
分析吡非尼酮在特发性肺纤维化（IPF）试验中的疗效和不良事件（AE）。方法：检索MEDLINE、Cochrane图书馆和ClinicalTrials.gov中2016年6月之前发表的研究。确定所有关键词为IPF或特发性肺纤维化或肺纤维化以及吡非尼酮或艾思瑞的临床试验研究。由2名独立研究人员进行质量评估和数据提取。对随机对照试验（RCT）进行荟萃分析，并计算相对风险（RR）和95%置信区间（95%CI）。结果：本综述纳入5项研究，涉及1568名参与者。荟萃分析显示，吡非尼酮降低了用力肺活量（FVC）较基线水平下降≥10%的风险（相对风险：0.62；95%CI：0.51 - 0.76，p<0.001）。与安慰剂组相比，吡非尼酮组的不良事件发生率显著更高。吡非尼酮未显著降低任何原因导致的死亡率（比值比：0.63；95%CI：0.36 - 1.09）。结论：本研究表明，吡非尼酮可降低IPF患者中以FVC下降评估的疾病进展。吡非尼酮是IPF患者的一种合适治疗选择。
