医疗保健获取对哮喘治疗效果的影响：对哮喘网络升级黄区吸入皮质激素预防加重（STICS）临床试验的重新分析。
Modification of asthma treatment efficacy by healthcare access: A reanalysis of AsthmaNet Step-Up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations (STICS) clinical trial.
机构信息
Drexel University Dornsife School of Public Health, Department of Environmental and Occupational Health, USA.
University of Pittsburgh Center for Social and Urban Research, USA.
出版信息
Respir Med. 2024 Nov-Dec;234:107853. doi: 10.1016/j.rmed.2024.107853. Epub 2024 Nov 5.
BACKGROUND
While randomized controlled trials (RCTs) in asthma management are designed to balance known and unknown variables across treatment groups, including social and environmental co-exposures, it remains important to consider how these co-exposures influence disease progression and treatment outcomes. The importance of considering socio-environmental co-exposures in the context of asthma is twofold: 1) asthma disproportionately affects low-income urban communities, where air pollution and chronic stress are pervasive; and 2) despite the wide range of asthma treatments, inadequate disease control persists.
METHODS
In the present ancillary study of the Step-Up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations (STICS) RCT, we investigated how socio-environmental factors, such as air pollution exposure and healthcare access, modify the effect of inhaled corticosteroid (ICS) therapy in children with asthma. The original STICS RCT evaluated the efficacy and safety of increasing the dose of inhaled glucocorticoids from a baseline daily low dose to five times the daily dose for 7 days in school-age children with mild -to-moderate persistent asthma who began to have short-term loss of asthma control (Jackson et al., 2018 Mar 8) [1]. Our study adds onto those findings by incorporating residential level particulate matter 2.5 μg/m3 (PM2.5) and geographic health provider shortage areas (HPSA) as potential modifiers.
RESULTS
Consistent with the main trial results, we did not find a difference in the number of exacerbations between treatment arms. However, we found the effect of receiving 5xICS, as compared with 1xICS on the time to prednisone was significantly different for children living in areas a shortage of health professionals (HR: 2.09; 95 % CI: 0.74, 5.95) than for children living in no shortage areas (HR: 0.40; 95 % CI: 0.21, 0.77).
CONCLUSION
This finding underscores the importance of considering environmental and social factors in asthma treatment.
TRIAL REGISTRATION
ClinicalTrials.gov ID NCT02066129 https://clinicaltrials.gov/study/NCT02066129.
背景
虽然哮喘管理中的随机对照试验 (RCT) 旨在平衡治疗组之间已知和未知的变量，包括社会和环境的共同暴露，但仍有必要考虑这些共同暴露如何影响疾病进展和治疗结果。在哮喘背景下考虑社会环境共同暴露的重要性有两个方面：1) 哮喘不成比例地影响低收入城市社区，那里空气污染和慢性压力普遍存在；2) 尽管有广泛的哮喘治疗方法，但疾病控制仍然不足。
方法
在 Step-Up Yellow Zone 吸入皮质类固醇预防加重 (STICS) RCT 的本次辅助研究中，我们调查了社会环境因素（如空气污染暴露和医疗保健获取）如何改变吸入皮质类固醇 (ICS) 治疗对哮喘儿童的影响。原始 STICS RCT 评估了在开始短期哮喘控制丧失的轻度至中度持续性哮喘的学龄儿童中，将吸入糖皮质激素的剂量从基线每日低剂量增加到每日剂量的五倍 7 天的疗效和安全性 (Jackson 等人，2018 年 3 月 8 日) [1]。我们的研究通过将住宅水平的 2.5 微克/立方米颗粒物 (PM2.5) 和地理卫生提供者短缺地区 (HPSA) 作为潜在调节剂纳入研究，补充了这些发现。
结果
与主要试验结果一致，我们没有发现治疗组之间发作次数的差异。然而，我们发现与接受 1xICS 相比，接受 5xICS 的儿童在接受泼尼松治疗的时间上存在显著差异，这与居住在卫生专业人员短缺地区的儿童（HR：2.09；95%CI：0.74，5.95）相比，而不是居住在没有短缺地区的儿童（HR：0.40；95%CI：0.21，0.77）。
结论
这一发现强调了在哮喘治疗中考虑环境和社会因素的重要性。
试验注册
ClinicalTrials.gov ID NCT02066129 https://clinicaltrials.gov/study/NCT02066129.
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