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评估哮喘患者的数字依从性支持:ADITION非干预性研究

Evaluating digital adherence support in asthma: the ADITION non-interventional study.

作者信息

Woehrle Holger, Driemert Jens, Jerrentrup Lukas, Schiefer Conrad, Bushart Gregor, Schwab Sauerbeck Inessa

机构信息

Lungenzentrum Ulm, Ulm, Germany.

Lungenarztpraxis Hellersdorf, Berlin, Germany.

出版信息

ERJ Open Res. 2025 Mar 3;11(2). doi: 10.1183/23120541.00734-2024. eCollection 2025 Mar.

Abstract

BACKGROUND

Poor adherence to asthma maintenance therapy is associated with worse outcomes. A solution could be digital adherence support. This study evaluated asthma control and adherence in patients using mometasone furoate/indacaterol/glycopyrronium (MF/IND/GLY) with a digital support system or using any inhaled corticosteroid/long-acting β-agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) combination without support.

METHODS

This prospective, non-interventional, multicentre, open-label study enrolled adults with asthma in Germany. Prior to inclusion, treatment was initiated with MF/IND/GLY with digital support or with any ICS/LABA/LAMA without digital support. The primary end-point was change in Asthma Control Test (ACT) at 6 months.

RESULTS

Of 222 and 203 patients in the MF/IND/GLY plus digital support and ICS/LABA/LAMA groups, 76.1% and 74.9% completed follow-up, respectively. Baseline mean ACT total scores were 17.0 and 14.7, with mean changes from baseline at 6 months of 3.0 and 4.1, respectively; following propensity matching (n=92 per group), mean changes were similar in the two groups, with overlapping 95% confidence intervals (2.9 (95% CI 1.9-3.9) and 4.0 (95% CI 3.0-5.1), respectively). At enrolment, patients were overall moderately adherent to maintenance therapy, with limited changes over the study. The overall incidence of adverse events was similar in the two groups (29.5% and 27.3% of patients, respectively).

CONCLUSIONS

Patients using MF/IND/GLY with digital support had similar improvements in asthma control to those receiving ICS/LABA/LAMA alone, with minimal changes in adherence. These results illustrate the challenges in evaluating asthma control and adherence in non-interventional studies. Further studies are required to evaluate the value of digital support systems and how they can be used to optimise inhaler adherence.

摘要

背景

哮喘维持治疗依从性差与预后较差相关。一种解决方案可能是数字化依从性支持。本研究评估了使用糠酸莫米松/茚达特罗/格隆溴铵(MF/IND/GLY)并配备数字化支持系统的患者以及使用任何吸入性糖皮质激素/长效β受体激动剂/长效毒蕈碱拮抗剂(ICS/LABA/LAMA)联合用药但无支持的患者的哮喘控制情况和依从性。

方法

这项前瞻性、非干预性、多中心、开放标签研究纳入了德国的成年哮喘患者。纳入研究前,患者开始使用MF/IND/GLY并接受数字化支持治疗,或使用任何ICS/LABA/LAMA但不接受数字化支持治疗。主要终点是6个月时哮喘控制测试(ACT)的变化。

结果

MF/IND/GLY加数字化支持组和ICS/LABA/LAMA组的222例和203例患者中,分别有76.1%和74.9%完成了随访。基线时ACT总分均值分别为17.0和14.7,6个月时相对于基线的均值变化分别为3.0和4.1;倾向匹配后(每组n = 92),两组的均值变化相似,95%置信区间重叠(分别为2.9(95%CI 1.9 - 3.9)和4.0(95%CI 3.0 - 5.1))。入组时,患者总体上对维持治疗的依从性中等,研究期间变化有限。两组不良事件的总体发生率相似(分别为29.5%和27.3%的患者)。

结论

使用MF/IND/GLY并配备数字化支持的患者在哮喘控制方面的改善与单独接受ICS/LABA/LAMA治疗的患者相似,依从性变化极小。这些结果说明了在非干预性研究中评估哮喘控制和依从性的挑战。需要进一步研究来评估数字化支持系统的价值以及如何利用它们来优化吸入器的依从性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8b4/11874225/0ab614b2becf/00734-2024.01.jpg

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