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面向患者的哮喘数字吸入器:系统评价与荟萃分析

Patient-Facing Digital Inhalers for Asthma: A Systematic Review and Meta-Analysis.

作者信息

Ologundudu Leonardo, Rayner Daniel G, Oppenheimer John, Sumino Kaharu, Hoyte Flavia, Rivera-Spoljaric Katherine, Perry Tamara T, Nyenhuis Sharmilee M, Chipps Bradley, Israel Elliot, Shade Lindsay E, Press Valerie G, Rangel Susana, Guyatt Gordon H, McCabe Ellen, O'Byrne Paul M, Hall Lisa, Orr Hilarry, Sue-Wah-Sing Dia, Melendez Angel, Winders Tonya, Przywara Kathy, Gardner Donna D, Rank Matthew A, Bacharier Leonard B, Mosnaim Giselle, Chu Derek K

机构信息

Evidence in Allergy Group and McMaster University, Hamilton, Ont, Canada.

Evidence in Allergy Group and McMaster University, Hamilton, Ont, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ont, Canada; Schulich School of Medicine & Dentistry, Western University, London, Ont, Canada.

出版信息

J Allergy Clin Immunol Pract. 2025 Jul;13(7):1824-1835. doi: 10.1016/j.jaip.2025.04.039. Epub 2025 Apr 30.

Abstract

BACKGROUND

The benefits and harms of patient-facing digital inhalers (inhalers with a sensor providing patients immediate feedback on adherence and technique) for asthma remain unclear.

OBJECTIVE

To systematically synthesize treatment outcomes of patient-facing digital inhalers for asthma.

METHODS

As part of developing upcoming American Academy of Allergy, Asthma & Immunology and American College of Allergy, Asthma, and Immunology Joint Task Force on Practice Parameters severe and difficult-to-control asthma guidelines, we searched MEDLINE, Embase, CENTRAL, CINAHL, PsycINFO, International Clinical Trials Registry Platform (ICTRP), and Latin American and Caribbean Literature on Health Sciences (LILACS), and monitored for additional studies to April 1, 2025, for randomized controlled trials evaluating patient-facing digital inhalers in asthma. Paired reviewers independently screened records and extracted data. Individual patient-level data in random effects analysis of covariance models addressed asthma control and asthma-related quality of life. Random-effects meta-analyses addressed severe exacerbations and harms. We used the Grading of Recommendations Assessment, Development and Evaluations (GRADE) approach to assess certainty of evidence (PROSPERO CRD42024525051).

RESULTS

Twelve trials enrolled 2,483 children (aged 4-17 y) and adults with asthma. Patient-facing digital inhalers probably improve asthma control (Asthma Control Test, mean difference 0.63 [95% confidence interval {95% CI} 0.29-0.96]; 44.3% vs 39.8% achieving a 3-point increase, moderate certainty) and may reduce severe exacerbations in patients at high risk for future exacerbations (risk ratio 0.89 [95% CI 0.69-1.16]; risk difference 45 fewer per 1,000 [95% CI 127 fewer to 66 more per 1,000], low certainty), with little to no difference in asthma-related quality of life (low certainty). The median of mean device failure rate was 12%, with trials reporting issues regarding sensor synchronization with smartphones (very low certainty). One trial reported a protected health information exposure while using patient-facing digital inhalers.

CONCLUSIONS

Patient-facing digital inhalers probably improve asthma control and may reduce severe asthma exacerbations in patients at high risk for future exacerbations with minimal harm.

摘要

背景

面向患者的数字吸入器(带有传感器,可为患者提供关于依从性和使用技巧的即时反馈的吸入器)对哮喘的益处和危害仍不明确。

目的

系统综合面向患者的数字吸入器治疗哮喘的结果。

方法

作为即将制定的美国过敏、哮喘与免疫学会以及美国过敏、哮喘和免疫学会关于重度和难治性哮喘实践参数联合工作组指南的一部分,我们检索了MEDLINE、Embase、CENTRAL、CINAHL、PsycINFO、国际临床试验注册平台(ICTRP)以及拉丁美洲和加勒比地区健康科学文献数据库(LILACS),并持续监测至2025年4月1日,以获取评估面向患者的数字吸入器治疗哮喘的随机对照试验。两名评审员独立筛选记录并提取数据。协方差模型随机效应分析中的个体患者层面数据涉及哮喘控制和哮喘相关生活质量。随机效应荟萃分析涉及重度发作和危害。我们采用推荐分级评估、制定和评价(GRADE)方法评估证据的确定性(PROSPERO CRD42024525051)。

结果

12项试验纳入了2483名患有哮喘的儿童(4至17岁)和成人。面向患者的数字吸入器可能改善哮喘控制(哮喘控制测试,平均差值0.63 [95%置信区间{95%CI} 0.29 - 0.96];实现3分提升的比例为44.3%对39.8%,中等确定性),并且可能降低未来发作高风险患者的重度发作(风险比0.89 [95%CI 0.69 - 1.16];每1000人风险差值少45例[95%CI每1000人少127例至多66例],低确定性),哮喘相关生活质量几乎没有差异(低确定性)。平均设备故障率中位数为12%,有试验报告了传感器与智能手机同步方面的问题(极低确定性)。一项试验报告在使用面向患者的数字吸入器时出现了受保护健康信息暴露的情况。

结论

面向患者的数字吸入器可能改善哮喘控制,并可能降低未来发作高风险患者的重度哮喘发作,危害极小。

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