吡非尼酮治疗特发性肺纤维化的有效性和安全性。
Efficacy and Safety of Pirfenidone in Advanced Idiopathic Pulmonary Fibrosis.
出版信息
Respiration. 2019;97(3):242-251. doi: 10.1159/000492937. Epub 2018 Oct 17.
BACKGROUND
Although phase 3 trials showed significant efficacy and acceptable safety profiles for pirfenidone in mild-to-moderate idiopathic pulmonary fibrosis (IPF), data on advanced IPF are limited.
OBJECTIVES
The study aimed to evaluate the efficacy and safety of pirfenidone in advanced IPF patients.
METHODS
The clinical data of 138 IPF patients (advanced group: 27%) treated with pirfenidone were retrospectively reviewed and compared between advanced and non-advanced groups. Advanced IPF was defined as (1) forced vital capacity (FVC) < 50% predicted or (2) diffusing capacity for carbon monoxide < 30% predicted.
RESULTS
The mean treatment duration was 51.3 weeks, and lung function analysis was performed in 81 patients (17 in the advanced group). Changes in FVC and total lung capacity (TLC) were significantly reduced at 6 months after treatment in both the advanced (ΔFVC [6 months]: -6.3 [before] vs. 0.7% predicted [after]; ΔTLC: -5.3 vs. 0.8) and non-advanced (ΔFVC: -3.4 vs. 0.5; ΔTLC: -3.1 vs. -0.9) groups. The rate of decline in FVC and TLC was significant before treatment, but not after treatment in the advanced (FVC: -1.27 [before] vs. 0.21% predicted/month [after]; TLC: -0.89 vs. -0.15) and non-advanced (FVC: -0.60 vs. -0.20; TLC: -0.54 vs. -0.17) groups. The advanced group showed a similar rate of adverse events (AEs) (78.4 vs. 88.1%, p = 0.270), but more serious AEs (40.5 vs. 10.9%, p < 0.001) including death (24.3 vs. 5.0%, p = 0.002).
CONCLUSIONS
In advanced IPF, pirfenidone showed similar efficacy and safety to non-advanced IPF except for serious AEs, which may be due to the advanced status itself.
背景
虽然三期临床试验表明吡非尼酮在轻中度特发性肺纤维化（IPF）中具有显著疗效和可接受的安全性，但关于晚期 IPF 的数据有限。
目的
本研究旨在评估吡非尼酮在晚期 IPF 患者中的疗效和安全性。
方法
回顾性分析了 138 例接受吡非尼酮治疗的 IPF 患者（晚期组：27%）的临床资料，并将晚期和非晚期组进行比较。晚期 IPF 定义为（1）用力肺活量（FVC）<预测值的 50%或（2）一氧化碳弥散量（DLCO）<预测值的 30%。
结果
平均治疗时间为 51.3 周，81 例患者（晚期组 17 例）进行了肺功能分析。治疗后 6 个月时，晚期组（ΔFVC[6 个月]：-6.3[治疗前]vs.预测值的 0.7%[治疗后]；ΔTLC：-5.3 vs.预测值的 0.8%）和非晚期组（ΔFVC：-3.4 vs.预测值的 0.5%；ΔTLC：-3.1 vs.预测值的-0.9%）的 FVC 和总肺容量（TLC）均明显下降。治疗前 FVC 和 TLC 下降率显著，但治疗后晚期组（FVC：-1.27[治疗前]vs.预测值每月 0.21%[治疗后]；TLC：-0.89 vs.预测值的-0.15%）和非晚期组（FVC：-0.60 vs.预测值的 0.20%；TLC：-0.54 vs.预测值的-0.17%）的下降率均无统计学意义。晚期组不良反应（AE）发生率相似（78.4% vs. 88.1%，p=0.270），但严重 AE 发生率更高（40.5% vs. 10.9%，p<0.001），包括死亡（24.3% vs. 5.0%，p=0.002）。
结论
在晚期 IPF 中，吡非尼酮的疗效和安全性与非晚期 IPF 相似，但严重 AE 发生率更高，这可能与晚期状态本身有关。
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