CERS, NIHR Leicester Biomedical Research Centre, Leicester, East Midlands, UK
Department of Respiratory Sciences, University of Leicester, Leicester, UK.
Thorax. 2022 Jul;77(7):690-696. doi: 10.1136/thoraxjnl-2021-217072. Epub 2021 Oct 27.
Chronic obstructive pulmonary disease (COPD) is characterised by symptomatic dyspnoea and reduced exercise tolerance, in part as a result muscle weakness, for which inspiratory muscle training (IMT) may be useful. Excess mucus hypersecretion commonly coexists in COPD and may lead to reduce ventilation, further impacting on breathlessness. Devices for sputum clearance may be employed to aid mucus expectoration. This trial aimed to explore the effectiveness of a combined IMT and high-frequency airway oscillating (HFAO) device in the management of dyspnoea.
This was a double-blinded, randomised sham-controlled trial which recruited symptomatic patients with COPD. Patients were randomised to either a HFAO device (Aerosure) or sham device for 8 weeks, three times a day. The primary outcome was the Chronic Respiratory Questionnaire dyspnoea (CRQ-D) domain. Pre-specified subgroup analyses were performed including those with respiratory muscle weakness, excessive sputum and frequent exacerbators.
104 participants (68% men, mean (SD) age 69.75 years (7.41), forced expiratory volume in 1 s per cent predicted 48.22% (18.75)) were recruited to this study with 96 participants completing. No difference in CRQ-D was seen between groups (0·28, 95% CI -0.19 to 0.75, p=0.24), though meaningful improvements were seen over time in both groups (mean (SD) HFAO 0.45 (0.78), p<0.01; sham 0.73 (1.09), p<0.01). Maximal inspiratory pressure significantly improved in the HFAO group over sham (5.26, 95% CI 0.34 to 10.19, p=0.05). Similar patterns were seen in the subgroup analysis.
There were no statistical differences between the HFAO and the sham group in improving dyspnoea measured by the CRQ-D.
ISRCTN45695543.
慢性阻塞性肺疾病（COPD）的特征是症状性呼吸困难和运动耐量降低，部分原因是肌肉无力，对此吸气肌训练（IMT）可能有用。COPD 常伴有过度黏液分泌，可能导致通气减少，进一步加重呼吸困难。可使用排痰装置来帮助排痰。本试验旨在探讨联合使用 IMT 和高频气道振荡（HFAO）装置治疗呼吸困难的效果。
这是一项双盲、随机假对照试验，招募了有症状的 COPD 患者。患者被随机分配到 HFAO 装置（Aerosure）或假装置组，每天 3 次，共 8 周。主要结局是慢性呼吸系统问卷呼吸困难（CRQ-D）域。进行了预先指定的亚组分析，包括呼吸肌无力、痰液过多和频繁加重者。
本研究共招募了 104 名参与者（68%为男性，平均（SD）年龄 69.75 岁（7.41），1 秒用力呼气量占预计值的百分比 48.22%（18.75%）），96 名参与者完成了研究。两组间 CRQ-D 无差异（0·28，95%CI-0.19 至 0.75，p=0.24），但两组均随时间出现有意义的改善（HFAO 组平均（SD）0.45（0.78），p<0.01；假装置组 0.73（1.09），p<0.01）。HFAO 组的最大吸气压力较假装置组显著改善（5.26，95%CI0.34 至 10.19，p=0.05）。亚组分析中也出现了类似的模式。
在使用 CRQ-D 测量呼吸困难的改善方面，HFAO 组与假装置组之间没有统计学差异。
ISRCTN45695543。
