长期使用呼气正压装置治疗慢性阻塞性肺疾病患者的疗效和安全性：一项随机对照试验。

Efficacy and safety of long-term use of a positive expiratory pressure device in chronic obstructive pulmonary disease patients, a randomized controlled trial.

机构信息

School of Nursing and Rehabilitation, Shandong University, Jinan, 250012, Shandong, China.

Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China.

出版信息

BMC Pulm Med. 2023 Jan 16;23(1):17. doi: 10.1186/s12890-023-02319-5.

DOI:10.1186/s12890-023-02319-5

PMID:36647057

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9841661/

Abstract

BACKGROUND

Exercise intolerance is among the most common symptoms experienced by patients with chronic obstructive pulmonary disease (COPD), which is associated with lung dynamic hyperinflation (DH). There was evidence that positive expiratory pressure (PEP), which could be offered by less costly devices, could reduce DH. The purpose of this study was to evaluate the efficacy and safety of long-term domiciliary use of PEP device in subjects with COPD.

METHODS

A randomized controlled trial was conducted and 25 Pre-COPD or mild-to-very severe subjects with COPD were randomized to intervention group (PEP device, PEP = 5 cmHO, n = 13) and control group (Sham-PEP device, PEP = 0 cmHO, n = 12). PEP device was a spring-loaded resistor face mask. Subjects were treated 4 h per day for a total of 2 months. Six-minute walk test (6MWT), pulmonary function, the Modified British Medical Research Council score, and partial pressure of end-tidal carbon dioxide were evaluated at baseline and after two months.

RESULTS

The 6MWD (- 71.67 ± 8.70 m, P < 0.001), end-dyspnea (P = 0.002), and end-fatigue (P = 0.022) improved significantly in the intervention group when compared with the control group. All subjects in the intervention group reported that 4 h of daily use of the PEP device was well tolerated and accepted and there were no adverse events.

CONCLUSION

Regular daily use of PEP device is safe and may improve exercise capacity in subjects with COPD or pre-COPD. PEP device could be used as an add-on to pulmonary rehabilitation programs due to its efficacy, safety, and low cost.

TRIAL REGISTRATION

The study was prospectively registered on ClinicalTrials.gov (NCT04742114).

摘要

背景

运动不耐受是慢性阻塞性肺疾病（COPD）患者最常见的症状之一，与肺动态过度充气（DH）有关。有证据表明，通过成本较低的设备提供正呼气压力（PEP）可以减少 DH。本研究旨在评估长期家庭使用 PEP 设备对 COPD 患者的疗效和安全性。

方法

进行了一项随机对照试验，将 25 名预 COPD 或轻度至重度 COPD 患者随机分为干预组（PEP 设备，PEP=5cmH2O，n=13）和对照组（假 PEP 设备，PEP=0cmH2O，n=12）。PEP 设备是一种带弹簧的电阻面罩。患者每天接受治疗 4 小时，共 2 个月。在基线和 2 个月后评估 6 分钟步行试验（6MWT）、肺功能、改良英国医学研究委员会评分和呼气末二氧化碳分压。