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初次使用三种不同干粉吸入器的患者所犯严重吸入器技术错误的比较:一项随机、交叉、开放标签研究。

Comparison of serious inhaler technique errors made by device-naïve patients using three different dry powder inhalers: a randomised, crossover, open-label study.

作者信息

Chrystyn Henry, Price David B, Molimard Mathieu, Haughney John, Bosnic-Anticevich Sinthia, Lavorini Federico, Efthimiou John, Shan Dawn, Sims Erika, Burden Anne, Hutton Catherine, Roche Nicolas

机构信息

Inhalation Consultancy Ltd, Yeadon, Leeds, West Yorkshire, UK.

Research in Real-Life, 5a Coles Lane, Oakington, Cambridge, UK.

出版信息

BMC Pulm Med. 2016 Jan 14;16:12. doi: 10.1186/s12890-016-0169-5.

Abstract

BACKGROUND

Serious inhaler technique errors can impair drug delivery to the lungs. This randomised, crossover, open-label study evaluated the proportion of patients making predefined serious errors with Pulmojet compared with Diskus and Turbohaler dry powder inhalers.

METHODS

Patients ≥18 years old with asthma and/or COPD who were current users of an inhaler but naïve to the study devices were assigned to inhaler technique assessment on Pulmojet and either Diskus or Turbohaler in a randomised order. Patients inhaled through empty devices after reading the patient information leaflet. If serious errors potentially affecting dose delivery were recorded, they repeated the inhalations after watching a training video. Inhaler technique was assessed by a trained nurse observer and an electronic inhalation profile recorder.

RESULTS

Baseline patient characteristics were similar between randomisation arms for the Pulmojet-Diskus (n = 277) and Pulmojet-Turbohaler (n = 144) comparisons. Non-inferiority in the proportions of patients recording no nurse-observed serious errors was demonstrated for both Pulmojet versus Diskus, and Pulmojet versus Turbohaler; therefore, superiority was tested. Patients were significantly less likely to make ≥1 nurse-observed serious errors using Pulmojet compared with Diskus (odds ratio, 0.31; 95 % CI, 0.19-0.51) or Pulmojet compared with Turbohaler (0.23; 0.12-0.44) after reading the patient information leaflet with additional video instruction, if required.

CONCLUSIONS

These results suggest Pulmojet is easier to learn to use correctly than the Turbohaler or Diskus for current inhaler users switching to a new dry powder inhaler.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT01794390 (February 14, 2013).

摘要

背景

严重的吸入器使用技术错误会影响药物输送至肺部。本随机、交叉、开放标签研究评估了使用普莫jet(Pulmojet)吸入器与都保(Diskus)和准纳器(Turbohaler)干粉吸入器相比,出现预定义严重错误的患者比例。

方法

年龄≥18岁、患有哮喘和/或慢性阻塞性肺疾病(COPD)且正在使用吸入器但对研究设备不熟悉的患者,被随机安排按顺序使用普莫jet吸入器以及都保或准纳器进行吸入技术评估。患者在阅读患者信息手册后通过空设备进行吸入。如果记录到可能影响剂量输送的严重错误,他们在观看培训视频后重复吸入。吸入技术由一名经过培训的护士观察员和一台电子吸入曲线记录器进行评估。

结果

在普莫jet - 都保(n = 277)和普莫jet - 准纳器(n = 144)比较的随机分组组间,基线患者特征相似。普莫jet与都保以及普莫jet与准纳器相比,在未被护士观察到严重错误的患者比例方面均显示出非劣效性;因此,进行了优效性测试。在阅读患者信息手册并在需要时观看额外视频指导后,与都保相比,使用普莫jet吸入器的患者出现≥1次被护士观察到的严重错误的可能性显著更低(优势比,0.31;95%置信区间,0.19 - 0.51),与准纳器相比亦是如此(0.23;0.12 - 0.44)。

结论

这些结果表明,对于从当前吸入器改用新的干粉吸入器的患者而言,普莫jet比准纳器或都保更容易学会正确使用。

试验注册

ClinicalTrials.gov标识符:NCT01794390(2013年2月14日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/86f9/4712500/5655a8212a48/12890_2016_169_Fig1_HTML.jpg

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