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高频胸壁振荡与呼气正压面罩治疗囊性纤维化的长期多中心随机对照研究。

Long-term multicentre randomised controlled study of high frequency chest wall oscillation versus positive expiratory pressure mask in cystic fibrosis.

机构信息

Division of Paediatric Respirology and Department of Physiotherapy, Cystic Fibrosis Clinic, BC Children's Hospital and University of British Columbia, Vancouver, British Columbia, Canada.

出版信息

Thorax. 2013 Aug;68(8):746-51. doi: 10.1136/thoraxjnl-2012-202915. Epub 2013 Feb 13.

Abstract

BACKGROUND

Positive expiratory pressure (PEP) is the most commonly used method of airway clearance (AC) in Canada for patients with cystic fibrosis (CF) whereas, in some countries, high frequency chest wall oscillation (HFCWO) is the preferred form of AC. There have been no long-term studies comparing the efficacy of HFCWO and PEP in the CF population.

OBJECTIVES

To determine the long-term efficacy of HFCWO compared with PEP mask therapy in the treatment of CF as measured by the number of pulmonary exacerbations (PEs).

METHODS

A randomised controlled study was performed in 12 CF centres in Canada. After a 2-month washout period, subjects were randomised to perform either HFCWO or PEP mask therapy for 1 year.

RESULTS

107 subjects were enrolled in the study; 51 were randomised to PEP and 56 to HFCWO. There were 19 dropouts within the study period, of which 16 occurred prior to or at the time of randomisation. There were significant differences between the groups in the mean number of PEs (1.14 for PEP vs 2.0 for HFCWO) and time to first PE (220 days for PEP vs 115 days for HFCWO, p=0.02). There was no significant difference in lung function, health-related quality of life scores or patient satisfaction scores between the two groups. PEP mask therapy required a shorter treatment time.

CONCLUSIONS

The results of this study favour PEP and do not support the use of HFCWO as the primary form of AC in patients with CF.

CLINICAL TRIAL REGISTRATION NUMBER

NCT00817180.

摘要

背景

在加拿大,对于囊性纤维化(CF)患者,正压呼气(PEP)是最常用的气道清除(AC)方法,而在一些国家,高频胸壁振荡(HFCWO)是首选的 AC 形式。目前还没有比较 HFCWO 和 PEP 在 CF 人群中的疗效的长期研究。

目的

确定 HFCWO 与 PEP 面罩治疗在 CF 治疗中的长期疗效,以肺加重(PE)的次数来衡量。

方法

在加拿大的 12 个 CF 中心进行了一项随机对照研究。经过 2 个月的洗脱期后,受试者被随机分为 HFCWO 组或 PEP 面罩治疗组,治疗时间为 1 年。

结果

本研究共纳入 107 例受试者,其中 51 例随机分为 PEP 组,56 例随机分为 HFCWO 组。在研究期间有 19 例脱落,其中 16 例发生在随机分组前或随机分组时。两组间平均 PE 次数(PEP 为 1.14,HFCWO 为 2.0)和首次 PE 时间(PEP 为 220 天,HFCWO 为 115 天,p=0.02)存在显著差异。两组间肺功能、健康相关生活质量评分或患者满意度评分无显著差异。PEP 面罩治疗所需的治疗时间更短。

结论

本研究结果支持 PEP,不支持将 HFCWO 作为 CF 患者的主要 AC 形式。

临床试验注册号

NCT00817180。

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