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特发性肺纤维化的肺康复长期疗效:一项随机对照试验。

Long-term effect of pulmonary rehabilitation in idiopathic pulmonary fibrosis: a randomised controlled trial.

机构信息

Department of Respiratory Medicine and Allergy, Tosei General Hospital, Seto, Japan.

Department of Respiratory Medicine and Allergology, Kindai University Faculty of Medicine, Osakasayama, Japan.

出版信息

Thorax. 2023 Aug;78(8):784-791. doi: 10.1136/thorax-2022-219792. Epub 2023 Apr 3.

DOI:10.1136/thorax-2022-219792
PMID:37012071
Abstract

BACKGROUND

Idiopathic pulmonary fibrosis (IPF) is characterised by worsening dyspnoea and exercise intolerance.

RESEARCH QUESTION

Does a long-term pulmonary rehabilitation improve exercise tolerance in patients with IPF treated with standard antifibrotic drugs, which are expected to reduce disease progression?

METHODS

This open-label randomised controlled trial was performed at 19 institutions. Stable patients receiving nintedanib were randomised into pulmonary rehabilitation and control groups (1:1). The pulmonary rehabilitation group underwent initial rehabilitation which included twice-weekly sessions of monitored exercise training for 12 weeks, followed by an at-home rehabilitation programme for 40 weeks. The control group received usual care only, without pulmonary rehabilitation. Both groups continued to receive nintedanib. The primary and main secondary outcomes were change in 6 min walking distance (6MWD) and change in endurance time (using cycle ergometry) at week 52.

RESULTS

Eighty-eight patients were randomised into pulmonary rehabilitation (n=45) and control (n=43) groups. Changes in 6MWD were -33 m (95% CI -65 to -1) and -53 m (95% CI -86 to -21) in the pulmonary rehabilitation and control groups, respectively, with no statistically significant difference (mean difference, 21 m (95% CI -25 to 66), p=0.38). Changes in endurance time were significantly better in the pulmonary rehabilitation (64 s, 95% CI -42.3 to 171)) than in the control (-123 s (95% CI -232 to -13)) group (mean difference, 187 s (95% CI 34 to 153), p=0.019).

INTERPRETATION

Although pulmonary rehabilitation in patients taking nintedanib did not improve 6MWD in the long term, it led to prolonged improvement in endurance time.

TRIAL REGISTRATION NUMBER

UMIN000026376.

摘要

背景

特发性肺纤维化(IPF)的特征是呼吸困难恶化和运动不耐受。

研究问题

在接受标准抗纤维化药物(预计可减缓疾病进展)治疗的 IPF 患者中,长期肺康复是否能提高运动耐量?

方法

这是一项在 19 个机构进行的开放性随机对照试验。接受尼达尼布治疗的稳定患者被随机分为肺康复组和对照组(1:1)。肺康复组接受初始康复治疗,包括 12 周每周两次的监测运动训练,然后进行 40 周的家庭康复计划。对照组仅接受常规护理,不进行肺康复。两组均继续接受尼达尼布治疗。主要和主要次要结局是第 52 周时 6 分钟步行距离(6MWD)的变化和耐力时间(使用功率自行车)的变化。

结果

88 名患者被随机分为肺康复组(n=45)和对照组(n=43)。6MWD 的变化分别为肺康复组-33m(95%CI-65 至-1)和对照组-53m(95%CI-86 至-21),无统计学差异(平均差异,21m(95%CI-25 至 66),p=0.38)。肺康复组耐力时间的变化明显优于对照组(64s,95%CI-42.3 至 171)(平均差异,187s(95%CI34 至 153),p=0.019)。

解释

尽管尼达尼布治疗的患者进行肺康复在长期内并未改善 6MWD,但耐力时间的延长得到了改善。

试验注册号

UMIN000026376。

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