住院肺康复改善哮喘控制——一项随机对照研究（EPRA，哮喘患者肺康复的效果）。
In-Patient Pulmonary Rehabilitation to Improve Asthma Control–A Randomized Controlled Study (EPRA, Effectiveness of Pulmonary Rehabilitation for Patients with Asthma).
机构信息
Clinic Bad Reichenhall, Center for Rehabilitation, Pneumology and Orthopedics, of Deutschen Rentenversicherung Bayern Süd, Bad Reichenhall, Germany; Helmholtz Zentrum München, Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH), Institute of Health Economics and Health Care Management, Comprehensive Pneumology Center Munich (CPC-M) - member of the German Center for Lung Research (DZL); Institut und Poliklinik für Arbeits-, Sozialund Umweltmedizin, Klinikum der Universität München, Comprehensive Pneumology Center Munich (CPC-M) - member of the German Center for Lung Research (DZL); Institute for Clinical Epidemiology and Biometry, Universität Würzburg; Chair of Rehabilitation Science, Universität Würzburg, Germany; IFT - Institut für Therapieforschung GmbH, München, Germany.
出版信息
Dtsch Arztebl Int. 2021 Jan 22;118(3):23-30. doi: 10.3238/arztebl.m2021.0003.
BACKGROUND
Despite the availability of effective pharmaceutical treatment options, many patients with asthma do not manage to control their illness. This randomized trial with a waiting-list control group examined whether a 3-week course of inpatient pulmonary rehabilitation (PR) improves asthma control (primary endpoint) and other secondary endpoints (e.g., quality of life, cardinal symptoms, mental stress). The subsequent observational segment of the study investigated the long-term outcome after PR.
METHODS
After approval of the rehabilitation´ by the insurance providers (T0), 412 adults with uncontrolled asthma (Asthma Control Test [ACT] score < 20 points) undergoing rehabilitation were assigned to either the intervention group (IG) or the waiting-list control group (CG). PR commenced 1 month (T1) after randomization in the IG and 5 months after randomization (T3) in the CG. Asthma control and the secondary endpoints were assessed 3 months after PR in the IG (T3) as an intention-to-treat analysis by means of analyses of covariance. Moreover, both groups were observed for a period of 12 months after the end of PR.
RESULTS
At T3 the mean ACT score was 15.76 points in the CG, 20.38 points in the IG. The adjusted mean difference of 4.71 points was clinically relevant (95% confidence interval [3.99; 5.43]; effect size, Cohen's d = 1.27). The secondary endpoints also showed clinically relevant effects in favor of the IG. A year after the end of rehabilitation the mean ACT score was 19.00 points, still clinically relevant at 3.54 points higher than when rehabilitation began. Secondary endpoints such as quality of life and cardinal symptoms (dyspnea, cough, expectoration, pain) and self-management showed moderate to large effects.
CONCLUSION
The trial showed that a 3-week course of PR leads to clinically relevant improvement in asthma control and secondary endpoints. Patients who do not achieve control of their asthma despite outpatient treatment therefore benefit from rehabilitation.
背景
尽管有有效的药物治疗选择，但许多哮喘患者仍无法控制病情。这项随机对照试验（设等待期对照组），旨在评估为期 3 周的住院肺康复（PR）是否能改善哮喘控制（主要终点）和其他次要终点（如生活质量、主要症状、精神压力）。研究的后续观察部分调查了 PR 后的长期结果。
方法
在康复计划获得保险公司批准后（T0），412 名未控制的哮喘患者（哮喘控制测试 [ACT]评分<20 分）接受康复治疗，随机分为干预组（IG）或等待期对照组（CG）。IG 于随机分组后 1 个月（T1）开始 PR，CG 于随机分组后 5 个月（T3）开始 PR。IG 于 PR 后 3 个月（T3）进行意向治疗分析，通过协方差分析评估哮喘控制和次要终点。此外，两组在 PR 结束后 12 个月内均进行观察。
结果
T3 时，CG 的平均 ACT 评分为 15.76 分，IG 为 20.38 分。调整后的平均差异为 4.71 分，具有临床意义（95%置信区间[3.99;5.43]；效应大小，Cohen's d = 1.27）。次要终点也显示出有利于 IG 的具有临床意义的效果。康复结束 1 年后，ACT 平均评分为 19.00 分，仍具有临床意义，比康复开始时高 3.54 分。次要终点如生活质量和主要症状（呼吸困难、咳嗽、咳痰、疼痛）和自我管理，显示出中度至较大的效果。
结论
该试验表明，为期 3 周的 PR 可显著改善哮喘控制和次要终点。尽管接受了门诊治疗，但哮喘仍未得到控制的患者从康复中获益。
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