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基于与健康状况和加重事件的相关性,识别 COPD 患者在使用干粉吸入器时的关键吸入技术错误:来自多国横断面观察性 PIFotal 研究的结果。

Identifying critical inhalation technique errors in Dry Powder Inhaler use in patients with COPD based on the association with health status and exacerbations: findings from the multi-country cross-sectional observational PIFotal study.

机构信息

General Practitioners Research Institute, Professor Enno Dirk Wiersmastraat 5, 9713 GH, Groningen, The Netherlands.

University of Groningen, University Medical Center Groningen, GRIAC Research Institute, Groningen, The Netherlands.

出版信息

BMC Pulm Med. 2023 Aug 17;23(1):302. doi: 10.1186/s12890-023-02566-6.

Abstract

BACKGROUND

Correct inhaler use depends on a complex interplay of factors, including device preparation and generating sufficient inspiratory flow. It is currently unknown which inhalation technique errors can be considered critical in Chronic Obstructive Pulmonary Disease (COPD) patients on Dry Powder Inhaler (DPI) maintenance therapy.

OBJECTIVE

To investigate the association between inhalation technique errors and health status or exacerbations in patients with COPD. Additionally, the association between the number of errors and COPD outcomes was determined.

METHODS

The PIFotal study is a cross-sectional multi-country observational study in a primary care setting, including 1434 COPD patients aged ≥ 40 years (50.1% female; mean age 69.2 yrs) using a DPI for their maintenance therapy. Inhalation technique was video recorded and scored by two independent researchers using inhaler-specific checklists. Health status was assessed with two questionnaires; the Clinical COPD Questionnaire (CCQ) and the COPD Assessment Test (CAT). The number of moderate and severe exacerbations in the past 12 months was recorded. Critical errors were identified based on their association with health status or exacerbations through multi-level prediction models adjusted for identified confounding.

RESULTS

Errors in inhalation technique steps 'Breathe in', 'Hold breath', and 'Breathe out calmly after inhalation' were significantly associated with poorer CCQ and CAT outcomes and thus deemed critical. None of the errors were significantly associated with moderate exacerbations. Patients with errors 'Preparation', 'Hold inhaler in correct position during inhalation', and 'Breathe in' had significantly more severe exacerbations, and therefore these errors were also deemed critical. 81.3% of patients with COPD made at least one critical error. Specific combinations of errors were associated with worse outcomes. The more inhalation technique errors identified, the poorer the health status and the higher the exacerbation rate.

CONCLUSION

In this study, we identified multiple critical inhalation technique errors in COPD patients using DPIs each associated with poorer outcomes. Explorative analysis revealed that specific combinations of errors may be of clinical relevance, especially those related to the inhalation manoeuvre. COPD outcomes worsened with increasing error count. These results warrant further prospective longitudinal studies to establish the effect of correcting these errors on COPD control.

TRIAL REGISTRATION

https://clinicaltrials.gov/ct2/show/NCT04532853 (31/08/2020).

摘要

背景

正确使用吸入器取决于一系列复杂的因素,包括设备准备和产生足够的吸气流量。目前尚不清楚在接受干粉吸入器(DPI)维持治疗的慢性阻塞性肺疾病(COPD)患者中,哪些吸入技术错误可以被认为是关键的。

目的

调查 COPD 患者吸入技术错误与健康状况或加重之间的关系。此外,还确定了错误数量与 COPD 结果之间的关系。

方法

PIFotal 研究是一项在初级保健环境中进行的多国家、横断面观察性研究,纳入了 1434 名年龄≥40 岁(50.1%为女性;平均年龄 69.2 岁)的 COPD 患者,他们使用 DPI 进行维持治疗。使用专用的吸入器检查表对吸入技术进行视频记录和评分。使用两个问卷评估健康状况;临床 COPD 问卷(CCQ)和 COPD 评估测试(CAT)。记录过去 12 个月中中度和重度加重的次数。根据与健康状况或加重的相关性,通过调整确定的混杂因素的多水平预测模型,确定关键错误。

结果

吸入技术步骤“吸气”、“屏住呼吸”和“吸气后平静呼气”中的错误与 CCQ 和 CAT 结果较差显著相关,因此被认为是关键错误。没有一个错误与中度加重显著相关。在“准备”、“在吸入过程中保持吸入器正确位置”和“吸气”中存在错误的患者,严重加重的发生率显著更高,因此这些错误也被认为是关键的。81.3%的 COPD 患者至少存在一个关键错误。特定的错误组合与更差的结果相关。识别的吸入技术错误越多,健康状况越差,加重率越高。

结论

在这项研究中,我们在使用 DPI 的 COPD 患者中发现了多个关键的吸入技术错误,每个错误都与较差的结果相关。探索性分析显示,特定的错误组合可能具有临床相关性,特别是与吸入动作相关的错误组合。随着错误数量的增加,COPD 结果恶化。这些结果需要进一步的前瞻性纵向研究,以确定纠正这些错误对 COPD 控制的影响。

试验注册

https://clinicaltrials.gov/ct2/show/NCT04532853(2020 年 8 月 31 日)。

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