中文译文：中药呼吸导引康复方案对特发性肺纤维化患者的影响：一项随机对照试验。
Pulmonary Daoyin as a traditional Chinese medicine rehabilitation programme for patients with IPF: A randomized controlled trial.
机构信息
Co-Construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan and Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou, China.
Department of Respiratory, The Third Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, China.
出版信息
Respirology. 2021 Apr;26(4):360-369. doi: 10.1111/resp.13972. Epub 2020 Nov 8.
BACKGROUND AND OBJECTIVE
IPF is a chronic progressive lung disease in which PR provides benefit for patients. PD, a TCM PR programme, has known effectiveness in COPD, but its utility in IPF is unknown. We investigated its effectiveness and safety in patients with IPF.
METHODS
A 6-month randomized controlled trial (RCT) was conducted in three Chinese clinics. Ninety-six participants diagnosed with IPF were randomly assigned to one of the three groups: the PD group received a PD programme two times a day, 5 days/week for 2 months, and the exercise group exercised via a stationary cycle ergometer, 30 min/day, 5 days/week for 2 months. Volunteers in the control group were advised to maintain their usual activities. Primary outcomes were changes from baseline in the 6MWD and HRQoL score on the SGRQ-I at 1 and 2 months (at the end of the intervention) and at 6 months (4 months after the intervention). Secondary outcomes measures included FVC, DL (% predicted) and the changes in mMRC.
RESULTS
The 6MWD was increased in the PD group compared to exercise and control groups. 6MWD increased by 60.44 m in the PD group, 32.16 m in the exercise group and 12.42 m in controls after the 2 months of rehabilitation programme. The between-group differences in the change from baseline were 28.78 m (95% CI: 0.54 to 56.01; P = 0.044) and 48.02 m (95% CI: 23.04 to 73.00; P < 0.001) at 2 months, and 25.61 m (95% CI: -0.67 to 51.89; P = 0.058) and 50.93 m (95% CI: 25.47 to 76.40; P < 0.001) at 6 months, respectively, including a difference exceeding the MCID. There was no significant change in the SGRQ-I score, the mMRC dyspnoea score, FVC and DL (% predicted) in either the PD or exercise groups.
CONCLUSION
Two months after the intervention, a clinically meaningful difference in 6MWD was observed favouring the PD programme. The PD programme is safe and effective as a rehabilitation intervention designed to increase exercise tolerance and is an appropriate substitute for PR.
背景与目的
特发性肺纤维化（IPF）是一种慢性进行性肺部疾病，吡非尼酮（PR）可使患者获益。中药穴位贴敷疗法（PD）对慢性阻塞性肺疾病（COPD）有确切疗效，但在 IPF 中的应用尚不清楚。我们旨在研究 PD 对 IPF 患者的有效性和安全性。
方法
这是一项在中国三家诊所进行的为期 6 个月的随机对照试验（RCT）。96 名确诊为 IPF 的患者被随机分配至 PD 组、运动组和对照组。PD 组接受 PD 治疗，每日 2 次，每周 5 天，连续 2 个月；运动组采用固定自行车进行运动，每日 30 分钟，每周 5 天，连续 2 个月；对照组接受常规治疗。主要结局为 1 个月和 2 个月（干预结束时）以及 6 个月（干预结束后 4 个月）时 6 分钟步行距离（6MWD）和圣乔治呼吸问卷（SGRQ-I）生活质量评分的变化。次要结局指标包括用力肺活量（FVC）、DL（%预计值）和 mMRC 呼吸困难评分的变化。
结果
与运动组和对照组相比，PD 组的 6MWD 增加。PD 组的 6MWD 在 2 个月的康复计划后增加了 60.44 米，运动组增加了 32.16 米，对照组增加了 12.42 米。组间差异为 28.78 米（95%置信区间：0.54 至 56.01；P = 0.044）和 48.02 米（95%置信区间：23.04 至 73.00；P<0.001），2 个月时；分别为 25.61 米（95%置信区间：-0.67 至 51.89；P = 0.058）和 50.93 米（95%置信区间：25.47 至 76.40；P<0.001），6 个月时。差异均超过了最小临床重要差异。PD 组和运动组的 SGRQ-I 评分、mMRC 呼吸困难评分、FVC 和 DL（%预计值）均无明显变化。
结论
干预 2 个月后，PD 组的 6MWD 明显改善，差异具有临床意义。PD 疗法是一种安全有效的康复干预措施，可提高运动耐量，是 PR 的合适替代疗法。
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