Pirfenidone in post-COVID-19 pulmonary fibrosis (FIBRO-COVID): a phase 2 randomised clinical trial.

Pirfenidone is an anti-fibrotic drug approved for idiopathic pulmonary fibrosis.

Pirfenidone是一种抗纤维化药物，已被批准用于特发性肺纤维化。

The efficacy and safety of pirfenidone in patients with fibrotic interstitial lung changes after recovery from severe COVID-19 pneumonia were evaluated.

评估了吡非尼酮在严重COVID-19肺炎恢复后出现纤维化间质性肺改变患者中的疗效和安全性。

Methods

This was a phase 2, double-blind, placebo-controlled, Spanish multicentre clinical trial. Patients were randomised to receive pirfenidone or placebo (2:1) for 24 weeks.

这是一项2期、双盲、安慰剂对照的西班牙多中心临床试验。患者被随机分为接受吡非尼酮或安慰剂（2:1）治疗24周。

The primary end-point was the proportion of patients that improved, considered when percentage change in forced vital capacity (FVC) was ≥10% and/or any reduction in the fibrotic score on chest high-resolution computed tomography (HRCT).

主要终点是患者改善的比例，当用力肺活量（FVC）的百分比变化≥10%和/或胸部高分辨率计算机断层扫描（HRCT）上的纤维化评分有所降低时，即认为改善。

Secondary end-points included health-related quality of life (HRQoL), exercise capacity and drug safety profile.

次要终点包括健康相关的生活质量（HRQoL）、运动能力和药物安全性特征。

Results

From 119 eligible patients, 113 were randomised and 103 were analysed (pirfenidone n=69 and placebo n=34).

在119名符合条件的患者中，有113名被随机分配，103名被纳入分析（吡非尼酮组n=69，安慰剂组n=34）。

Most patients were male (73.5%) and were receiving low-dose prednisone; mean age was 63.7 years and mean body mass index was 29 kg·m-2.

大多数患者为男性（占73.5%），正在接受低剂量泼尼松治疗；平均年龄为63.7岁，平均体重指数为29 kg·m-2。

The percentage of patients that improved was similar in the pirfenidone and placebo groups (79.7% versus 82.3%, respectively).

在吡非尼酮组和安慰剂组中，改善的患者百分比相似（分别为79.7%和82.3%）。

The mean predicted FVC increased by 12.74±20.6% with pirfenidone and 4.35±22.3% with placebo (p=0.071), and the HRCT (%) fibrotic score decreased by 5.44±3.69% with pirfenidone and 2.57±2.59% with placebo (p=0.52).

吡非尼酮组的平均预测用力肺活量（FVC）增加了12.74±20.6%，而安慰剂组增加了4.35±22.3%（p=0.071），并且吡非尼酮组的高分辨率计算机断层扫描（HRCT）的纤维化评分降低了5.44±3.69%，而安慰剂组降低了2.57±2.59%（p=0.52）。

Clinically meaningful improvement in HRQoL was not statistically different (55.2% in the pirfenidone group and 39.4% in the placebo group).

在健康相关生活质量（HRQoL）方面的临床意义改善在统计学上没有显著差异（吡非尼酮组为55.2%，安慰剂组为39.4%）。

Exercise capacity, adverse events and hospitalisations were similar between groups.

两组在运动能力、不良事件和住院方面相似。

No deaths were reported.

未报告有死亡病例。

Conclusions

The overall improvements in lung function and HRCT fibrotic score after 6 months with pirfenidone were not significantly different than with placebo.

使用吡非尼酮治疗6个月后，肺功能和HRCT纤维化评分的整体改善与安慰剂相比没有显著差异。