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在线正念干预(eMBI)在间质性肺疾病患者呼吸困难管理中的应用:一项随机临床试验。

Online Mindfulness-Based Intervention (eMBI) in management of dyspnea in patients with interstitial lung disease: A randomized clinical trial.

机构信息

Graduate Program in Applied Adult Health Sciences, Federal University of Minas Gerais, Belo Horizonte, Brazil.

Department of Gynecology and Obstetrics, School of Medicine, Federal University of Minas Gerais, Belo Horizonte, Brazil.

出版信息

Complement Ther Med. 2024 Dec;87:103106. doi: 10.1016/j.ctim.2024.103106. Epub 2024 Oct 31.

DOI:10.1016/j.ctim.2024.103106
PMID:39486748
Abstract

RATIONALE

Dyspnea and cough are frequent symptoms in ILD patients. The management of these symptoms is challenging, and evidence-based therapies are lacking.

OBJECTIVES

To evaluate the effect of an online Mindfulness-Based Intervention (eMBI) on reducing dyspnea in patients affected by different ILDs.

METHODS

This study was a prospective, open-label, controlled trial that included patients ≥18 years and a modified Medical Research Council (mMRC) dyspnea scale score of ≥ 1. Patients were randomized into either the eMBI or the control group (CG) for 8 weeks. The primary outcome was the change in the dyspnea mMRC scale. The Leicester Cough Questionnaire (LCQ), King's Brief Interstitial Lung Disease (K-BILD) questionnaire, and Depression, Anxiety, and Stress Scale (DASS-21) were performed before and after the eight weeks. All analyses were conducted on an intention-to-treat basis. The study was registered at the Brazilian Registry of Clinical Trials (ReBEC), RBR-3s4mf9y.

RESULTS

24 patients in the eMBI and 25 in the CG completed the intervention. In the eMBI group, compared to the control group, there was a greater proportion of patients with a reduction in dyspnea according to the mMRC scale score (48.9 % versus, 15.4 %, p = 0.001). There was no significant difference between the groups in the LCQ (p = 0.666), or in the K-BILD (p = 0.108), depression (p = 0.08), or anxiety (p = 0.869 or stress (p = 0.789). No moderate or severe adverse events were observed in either group.

CONCLUSIONS

Eight weeks eMBI is a potentially viable and safe approach, that can help manage dyspnea in ILD patients.

摘要

背景

呼吸困难和咳嗽是ILD 患者的常见症状。这些症状的管理具有挑战性,且缺乏基于证据的治疗方法。

目的

评估在线正念干预(eMBI)对减轻不同ILD 患者呼吸困难的效果。

方法

这是一项前瞻性、开放标签、对照试验,纳入了≥18 岁且改良的医学研究委员会(mMRC)呼吸困难量表评分≥1 的患者。患者被随机分为 eMBI 组或对照组(CG),干预 8 周。主要结局是呼吸困难 mMRC 量表评分的变化。在干预前后分别进行莱斯特咳嗽问卷(LCQ)、金氏简要间质性肺病(K-BILD)问卷和抑郁、焦虑和压力量表(DASS-21)的评估。所有分析均基于意向治疗原则进行。该研究在巴西临床试验注册处(ReBEC)进行了注册,注册号为 RBR-3s4mf9y。

结果

24 例患者进入 eMBI 组,25 例进入 CG。与 CG 相比,eMBI 组中根据 mMRC 量表评分呼吸困难减轻的患者比例更高(48.9% vs. 15.4%,p=0.001)。两组之间的 LCQ 评分(p=0.666)、K-BILD 评分(p=0.108)、抑郁评分(p=0.08)、焦虑评分(p=0.869)或压力评分(p=0.789)均无显著差异。两组均未观察到中度或重度不良事件。

结论

8 周的 eMBI 是一种可行且安全的方法,可以帮助管理ILD 患者的呼吸困难。

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