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哮喘的物理治疗呼吸训练:一项随机对照试验。

Physiotherapy breathing retraining for asthma: a randomised controlled trial.

机构信息

Faculty of Health Sciences, University of Southampton, Southampton, UK; NIHR Southampton Biomedical Research Centre, Southampton, UK.

Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.

出版信息

Lancet Respir Med. 2018 Jan;6(1):19-28. doi: 10.1016/S2213-2600(17)30474-5. Epub 2017 Dec 14.

Abstract

BACKGROUND

Despite effective pharmacotherapy, asthma continues to impair quality of life for most patients. Non-pharmacological approaches, including breathing retraining, are therefore of great interest to patients. However, clinicians rarely advocate breathing retraining and access to this intervention is restricted for most patients due to the limited availability of suitable physiotherapists and poor integration of breathing retraining into standard care. We aimed to assess the effectiveness of a digital self-guided breathing retraining intervention.

METHODS

In this randomised controlled trial, we recruited patients from 34 general practices in the UK. Eligibility criteria for patients with asthma were broad, comprising a physician diagnosis of asthma, age of 16-70 years, receipt of at least one anti-asthma medication in the previous year, and impaired asthma-related quality of life (Asthma Quality of Life Questionnaire [AQLQ] score of <5·5). We developed a self-guided intervention, which was delivered as a DVD plus a printed booklet (DVDB). Participants were randomly assigned to receive either the DVDB intervention, three face-to-face breathing retraining sessions, or standard care, in a 2:1:2 ratio, for 12 months. Randomisation was achieved using the Southampton Clinical Trials Unit telephone randomisation service by use of random number generators. The primary outcome was the AQLQ score in the intention-to-treat population at 12 months. The trial was powered to show equivalence between the two active intervention groups, and superiority of both intervention groups over usual care. Secondary outcomes included patient-reported and physiological measures of asthma control, patient acceptability, and health-care costs. This trial was registered with International Standard Randomised Controlled Trial Number registry, number ISRCTN88318003.

FINDINGS

Between Nov 5, 2012 and Jan 28, 2014, invitations to participate in the study were sent to 15 203 patients with general practitioner-diagnosed asthma, of whom 655 were recruited into the study. AQLQ scores at 12 months were significantly higher in the DVDB group (mean 5·40, SD 1·14) than in the usual care group (5·12, SD 1·17; adjusted mean difference 0·28, 95% CI 0·11 to 0·44), and in the face-to-face group (5·33, SD 1·06) than in the usual care group (adjusted mean difference 0·24, 95% CI 0·04 to 0·44); AQLQ scores were similar between the DVDB group and the face-to-face group (0·04, 95% CI -0·16 to 0·24). There were no significant differences between the randomisation groups in FEV1 or fraction of exhaled nitric oxide. 744 adverse events occurred in 272 patients: 101 (39%) of 261 patients in the DVDB group, 55 (42%) of 132 patients in the face-to-face group, and 132 (50%) of 262 in the usual care group, with patients reporting one or more event. 11 (4%) patients in the DVDB group, four (3%) patients in the face-to-face group, and 20 (8%) patients in the usual care group had a serious adverse event.

INTERPRETATION

Breathing retraining programmes improve quality of life in patients with incompletely controlled asthma despite having little effect on lung function or airway inflammation. Such programmes can be delivered conveniently and cost-effectively as a self-guided digital audiovisual programme, so might also reduce health-care costs.

FUNDING

UK National Institute of Health Research.

摘要

背景

尽管有有效的药物治疗,哮喘仍然会影响大多数患者的生活质量。因此,非药物治疗方法,包括呼吸训练,对患者来说非常感兴趣。然而,临床医生很少提倡呼吸训练,由于合适的物理治疗师的有限可用性以及呼吸训练与标准护理的整合不佳,大多数患者无法获得这种干预措施。我们旨在评估数字自我引导呼吸训练干预的效果。

方法

在这项随机对照试验中,我们从英国的 34 家普通诊所招募了患者。哮喘患者的入选标准很广泛,包括医生诊断的哮喘、年龄在 16-70 岁之间、过去一年至少接受过一种哮喘药物治疗以及哮喘相关生活质量受损(哮喘生活质量问卷[AQLQ]评分<5.5)。我们开发了一种自我引导干预措施,以 DVD 加印刷小册子(DVDB)的形式提供。参与者被随机分配接受 DVDB 干预、三次面对面呼吸训练课程或标准护理,比例为 2:1:2,为期 12 个月。随机化使用南安普顿临床试验单位电话随机化服务通过使用随机数生成器来实现。主要结局是在 12 个月时意向治疗人群的 AQLQ 评分。该试验具有显示两组活跃干预组之间等效性以及两组干预组均优于常规护理的优势。次要结局包括患者报告的和生理测量的哮喘控制、患者可接受性和医疗保健成本。该试验在国际标准随机对照试验登记处注册,编号为 ISRCTN88318003。

结果

在 2012 年 11 月 5 日至 2014 年 1 月 28 日期间,向 15,203 名由全科医生诊断为哮喘的患者发出了参加研究的邀请,其中 655 名患者被招募到研究中。DVDB 组的 AQLQ 评分在 12 个月时明显高于常规护理组(平均 5.40,SD 1.14)和面对面组(5.33,SD 1.06),常规护理组(调整后的平均差异为 0.28,95%CI 0.11-0.44);DVDB 组与面对面组的 AQLQ 评分相似(0.04,95%CI-0.16-0.24)。FEV1 或呼出一氧化氮分数在随机分组之间没有显著差异。272 名患者中有 744 例不良事件发生:261 名患者中 101 例(39%)在 DVDB 组,132 名患者中 55 例(42%)在面对面组,262 名患者中 132 例(50%)在常规护理组,患者报告有一个或多个事件。DVDB 组 11 名(4%)患者、面对面组 4 名(3%)患者和常规护理组 20 名(8%)患者发生严重不良事件。

解释

尽管对肺功能或气道炎症几乎没有影响,但呼吸训练计划可以改善控制不充分的哮喘患者的生活质量。这种方案可以方便、经济有效地作为自我引导的数字视听方案提供,因此也可能降低医疗保健成本。

资助

英国国家卫生研究院。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/04f9/5757422/46d1ad618e51/gr1.jpg

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