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慢性阻塞性肺疾病的振荡式呼气末正压治疗(O-COPD):一项随机对照试验

Oscillatory positive expiratory pressure therapy in COPD (O-COPD): a randomised controlled trial.

作者信息

Alghamdi Saeed M, Alsulayyim Abdullah S, Alasmari Ali M, Philip Keir E J, Buttery Sara C, Banya Winston A S, Polkey Michael I, Birring Surinder S, Hopkinson Nicholas S

机构信息

Clinical Technology, Umm Al-Qura University, Makkah, Saudi Arabia.

National Heart and Lung Institute, Imperial College London, London, UK.

出版信息

Thorax. 2023 Feb;78(2):136-143. doi: 10.1136/thorax-2022-219077. Epub 2022 Aug 10.

Abstract

BACKGROUND

Oscillatory positive expiratory pressure (OPEP) devices are intended to facilitate sputum clearance and reduce cough, but there is limited evidence for their effectiveness in COPD, or to guide patient selection. We aimed to assess the impact of OPEP therapy on quality of life and objective measures of cough and sleep disturbance in patients with COPD with regular sputum production.

METHODS

We enrolled stable patients with COPD, who reported sputum production every day or most days, into an assessor-blind, parallel-group, randomised controlled trial comparing 3 months of using an Acapella device against usual care (including use of the active cycle of breathing technique). The primary outcome was cough-related quality of life measured using the Leicester Cough Questionnaire (LCQ). Secondary outcomes included fatigue (Functional Assessment of Chronic Illness Therapy, FACIT score) and generic quality of life (EuroQol-5 Dimensions, EQ-5D). In a substudy (n=45), objective monitoring of cough and disturbance/movement during sleep were also available.

RESULTS

122 participants (61/61 OPEP/control) were recruited, 40% female, 17% smokers, FEV1 38 (25-56)% predicted, and age 62±10 years. 103 completed the study (55/48 OPEP/control). Use of OPEP was associated with an improvement in LCQ compared with controls; MD (95% CI) 1.03 (0.71 to 2.10); (p=0.03), FACIT score 4.68 (1.34 to 8.02); (p<0.001) and EQ-5D 4.00 (0.49 to 19.75); (p=0.04). There was also an improvement in cough frequency -60 (-43 to -95) coughs/24 hours (p<0.001), but no statistically significant effect on sleep disturbance was identified.

CONCLUSIONS

Regular use of an Acapella device improves symptoms and quality of life in people with COPD who produce sputum daily or most days.

TRIAL REGISTRATION NUMBER

ISRCTN44651852.

摘要

背景

振荡呼气正压(OPEP)装置旨在促进痰液清除并减轻咳嗽,但关于其在慢性阻塞性肺疾病(COPD)中的有效性或指导患者选择的证据有限。我们旨在评估OPEP治疗对有规律咳痰的COPD患者生活质量以及咳嗽和睡眠障碍客观指标的影响。

方法

我们招募了病情稳定、每天或大部分日子有咳痰的COPD患者,进行一项评估者盲法、平行组、随机对照试验,比较使用阿凯拉装置3个月与常规治疗(包括使用主动呼吸循环技术)的效果。主要结局是使用莱斯特咳嗽问卷(LCQ)测量的与咳嗽相关的生活质量。次要结局包括疲劳(慢性病治疗功能评估,FACIT评分)和一般生活质量(欧洲五维健康量表,EQ-5D)。在一项子研究(n = 45)中,还可对咳嗽以及睡眠期间的干扰/活动进行客观监测。

结果

共招募了122名参与者(OPEP组/对照组各61名),女性占40%,吸烟者占17%,预测第一秒用力呼气容积(FEV1)为38(25 - 56)%,年龄62±10岁。103名完成了研究(OPEP组/对照组各55/48名)。与对照组相比,使用OPEP与LCQ改善相关;平均差(95%置信区间)为1.03(0.71至2.10);(p = 0.03),FACIT评分为4.68(1.34至8.02);(p < 0.001),EQ-5D为4.00(0.49至19.75);(p = 0.04)。咳嗽频率也有所改善,为-60(-43至-95)次/24小时(p < 0.001),但未发现对睡眠障碍有统计学意义的影响。

结论

对于每天或大部分日子咳痰的COPD患者,定期使用阿凯拉装置可改善症状和生活质量。

试验注册号

ISRCTN44651852

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