Daynes Enya, Greening Neil J, Harvey-Dunstan Theresa C, Singh Sally J
Centre for Exercise & Rehabilitation Science, Leicester Respiratory Biomedical Research Unit, Glenfield Hospital, and the University of Leicester, Leicester, United Kingdom.
Respir Care. 2018 May;63(5):584-590. doi: 10.4187/respcare.05837. Epub 2018 Mar 13.
COPD is characterized by expiratory flow limitation, which results in symptomatic dyspnea and reduced exercise capacity. Changes in breathing mechanics mean the respiratory muscles are unable to respond to the ventilatory demands, increasing the sensation of dyspnea. A high-frequency oscillating device has been developed to improve dyspnea in patients with COPD. We conducted a feasibility trial to gain insight into the potential for recruitment, retention, and study design for a future randomized controlled trial.
Symptomatic subjects with COPD were included on the basis of a Medical Research Council (MRC) score ≥ 3 and FEV/FVC < 0.70). Patients were excluded if they received pulmonary rehabilitation within the last 6 months. The intervention employed the device for 8 weeks, 3 times daily. Clinical outcomes included the MRC score, maximal expiratory and inspiratory pressures (P/P), the incremental shuttle walk test (ISWT), and the endurance shuttle walk test (ESWT).
We successfully recruited 23 subjects with established COPD (65.2% male, mean age 65 ± 5.03 y, mean % predicted FEV 43.9 ± 16, mean FEV/FVC ratio 0.46 ± 0.13, and median [interquartile range] MRC 4 [3-5]). There was a significant change in MRC from 4 to 3 pre to post intervention ( = .003). There was a statistically significant difference in P < .008 and P = .044. There were no significant differences observed in the ISWT or ESWT.
This study design appeared feasible to proceed to a clinical effectiveness trial. The use of the device for 8 weeks showed a significant improvement in P, P, and reduced symptomatic dyspnea on the MRC dyspnea score. The results of this study should encourage a randomized controlled trial.
慢性阻塞性肺疾病（COPD）的特征是呼气气流受限，这会导致有症状的呼吸困难和运动能力下降。呼吸力学的改变意味着呼吸肌无法满足通气需求，从而增加了呼吸困难的感觉。已开发出一种高频振荡装置来改善COPD患者的呼吸困难。我们进行了一项可行性试验，以深入了解未来随机对照试验的招募、保留和研究设计的潜力。
纳入基于医学研究委员会（MRC）评分≥3且FEV/FVC<0.70的有症状的COPD患者。如果患者在过去6个月内接受过肺康复治疗，则将其排除。干预措施是使用该装置8周，每天3次。临床结果包括MRC评分、最大呼气和吸气压力（P/P）、递增往返步行试验（ISWT）和耐力往返步行试验（ESWT）。
我们成功招募了23名确诊为COPD的受试者（男性占65.2%，平均年龄65±5.03岁，预计FEV平均百分比为43.9±16，平均FEV/FVC比值为0.46±0.13，MRC中位数[四分位间距]为4[3-5]）。干预前后MRC评分从4显著降至3（=0.003）。P<0.008和P=0.044有统计学显著差异。在ISWT或ESWT中未观察到显著差异。
该研究设计似乎可行，可进行临床有效性试验。使用该装置8周显示P、P有显著改善，且MRC呼吸困难评分的症状性呼吸困难减轻。本研究结果应鼓励进行随机对照试验。
