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人动力雾化器治疗哮喘加重:一项随机平行组临床试验。

Treatment of asthma exacerbations with the human-powered nebuliser: a randomised parallel-group clinical trial.

机构信息

1] Department of Biomedical Engineering, Marquette University, Milwaukee, WI, USA [2] School of Medicine, University of Washington, Seattle, WA, USA.

Institute of Pastoral Studies and Neiswanger Institute of Bioethics, Stritch School of Medicine, Loyola University Chicago, Chicago, IL, USA.

出版信息

NPJ Prim Care Respir Med. 2014 Jun 26;24:14016. doi: 10.1038/npjpcrm.2014.16.

Abstract

BACKGROUND

Nebulisers aid the treatment of respiratory diseases, including asthma, but they require electricity and are often cost-prohibitive for low- and middle-income countries.

AIMS

The aim of this study was to compare a low-cost, human-powered nebuliser compressor with an electric nebuliser compressor for the treatment of mild to moderate asthma exacerbations in adults and children.

METHODS

This was a non-blinded, parallel-group, equivalence study, with 110 subjects between 6 and 65 years of age, conducted in the emergency department of a district hospital in Ilopango, El Salvador. Participants were assigned by random allocation to receive a 2.5-mg dose of salbutamol from the experimental human-powered nebuliser or the electric nebuliser control. All assigned participants completed treatment and were included in analysis. The study was not blinded as this was clinically unfeasible; however, data analysis was blinded.

RESULTS

The mean improvement in peak flow of the experimental and control groups was 37.5 (95% confidence interval (CI) 26.7-48.2) l/min and 38.7 (95% CI, 26.1-51.3) l/min, respectively, with a mean difference of 1.3 (95% CI, -15.1 to 17.7) l/min. The mean improvement in percent-expected peak flow for the experimental and control groups was 12.3% (95% CI, 9.1-15.5%) and 13.8% (95% CI, 9.8-17.9%), respectively, with a mean difference of 1.5% (95% CI, -3.6 to 6.6%).

CONCLUSIONS

The human-powered nebuliser compressor is equivalent to a standard nebuliser compressor for the treatment of mild-to-moderate asthma. (Funded by the Opus Dean's Fund, Marquette University College of Engineering; ClinicalTrials.gov NCT01795742.).

摘要

背景

雾化器有助于治疗呼吸系统疾病,包括哮喘,但它们需要电力,而且对于中低收入国家来说往往成本过高。

目的

本研究旨在比较一种低成本、人力驱动的雾化器压缩机与电动雾化器压缩机,用于治疗成人和儿童的轻度至中度哮喘急性发作。

方法

这是一项非盲、平行组、等效性研究,纳入了 110 名年龄在 6 至 65 岁之间的受试者,在萨尔瓦多伊洛潘戈区医院的急诊科进行。参与者通过随机分配接受实验性人力驱动雾化器或电动雾化器对照给予 2.5 毫克沙丁胺醇。所有分配的参与者都完成了治疗并纳入了分析。由于临床不可行,该研究未设盲,但数据分析设盲。

结果

实验组和对照组的峰流速平均改善分别为 37.5(95%置信区间 26.7-48.2)l/min 和 38.7(95%置信区间 26.1-51.3)l/min,平均差异为 1.3(95%置信区间 -15.1 至 17.7)l/min。实验组和对照组的预计峰流速平均改善百分比分别为 12.3%(95%置信区间 9.1-15.5%)和 13.8%(95%置信区间 9.8-17.9%),平均差异为 1.5%(95%置信区间 -3.6 至 6.6%)。

结论

人力驱动雾化器压缩机与标准雾化器压缩机在治疗轻度至中度哮喘方面等效。(由马凯特大学工程学院 Opus Dean's Fund 资助;ClinicalTrials.gov 注册号:NCT01795742。)

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