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正确使用和便于使用安慰剂 ELLIPTA 干粉吸入器在慢性阻塞性肺疾病的成年患者中。

Correct use and ease-of-use of placebo ELLIPTA dry-powder inhaler in adult patients with chronic obstructive pulmonary disease.

机构信息

Midwest Chest Consultants, St Charles, Missouri, United States of America.

US Medical Affairs, GSK, Research Triangle Park, Durham, North Carolina, United States of America.

出版信息

PLoS One. 2022 Aug 15;17(8):e0273170. doi: 10.1371/journal.pone.0273170. eCollection 2022.

Abstract

BACKGROUND

Inhaler technique errors are common in chronic obstructive pulmonary disease (COPD) treatment, potentially leading to poor disease management. Our pooled analysis approach assessed correct use and ease-of-use of a placebo ELLIPTA dry-powder inhaler (DPI) in patients with COPD.

METHODS

Adults with COPD from open-label/non-blinded studies evaluating a placebo ELLIPTA DPI and reporting outcomes of correct use (based on the ELLIPTA DPI patient information leaflet [PIL]) and/or ease-of-use were included. Correct use and ease-of use at study end were primary and secondary endpoints, respectively. Data from patients in the placebo ELLIPTA DPI arm of each study were pooled, and the intent-to-treat (ITT) population was used for all analyses.

RESULTS

Four placebo ELLIPTA DPI studies, reporting correct use (n = 4) and ease-of-use (n = 2), were included in the analysis. The ITT population comprised 1232 patients (mean age 66.2 years). For the primary endpoint, 80.1% (n = 975/1217) of patients demonstrated correct use at study end (95% confidence interval [CI]: 77.8%-82.3%). For the secondary endpoint, 95.7% (n = 797/833) of patients rated placebo ELLIPTA DPI use "easy"/"very easy" at study end (95% CI: 94.1%-97.0%). Correct use and "easy"/"very easy" user ratings remained high across younger (40-64 years) and older (≥65 years) age groups.

CONCLUSIONS

Across age groups, most patients used the placebo ELLIPTA DPI correctly and rated it "easy"/"very easy" to use. Consistent with the Global Initiative for Chronic Obstructive Lung Disease 2021 report, our findings emphasize that proper training and clear instructions on PILs are important for optimal inhaler use.

摘要

背景

在慢性阻塞性肺疾病(COPD)的治疗中,吸入器技术错误很常见,这可能导致疾病管理不善。我们的汇总分析方法评估了 COPD 患者使用安慰剂 ELLIPTA 干粉吸入器(DPI)的正确使用和易用性。

方法

纳入了来自评估安慰剂 ELLIPTA DPI 的开放标签/非盲研究的成年 COPD 患者,这些研究报告了正确使用(基于 ELLIPTA DPI 患者信息传单[PIL])和/或易用性的结果。研究结束时的正确使用和易用性分别是主要和次要终点。从每个研究的安慰剂 ELLIPTA DPI 臂中的患者数据中进行了汇总,并对所有分析使用了意向治疗(ITT)人群。

结果

纳入了四项安慰剂 ELLIPTA DPI 研究,报告了正确使用(n=4)和易用性(n=2)的结果。ITT 人群包括 1232 名患者(平均年龄 66.2 岁)。对于主要终点,80.1%(n=975/1217)的患者在研究结束时表现出正确使用(95%置信区间[CI]:77.8%-82.3%)。对于次要终点,95.7%(n=797/833)的患者在研究结束时评定安慰剂 ELLIPTA DPI 使用为“容易”/“非常容易”(95%CI:94.1%-97.0%)。在较年轻(40-64 岁)和较年长(≥65 岁)年龄组中,正确使用和“容易”/“非常容易”的用户评分仍然很高。

结论

在各个年龄组中,大多数患者正确使用了安慰剂 ELLIPTA DPI,并评定其“容易”/“非常容易”使用。与 2021 年全球慢性阻塞性肺疾病倡议报告一致,我们的发现强调了适当的培训和 PIL 上的清晰说明对于最佳吸入器使用非常重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f0b9/9377593/2a50fb107321/pone.0273170.g001.jpg

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