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美国重症哮喘患者全身使用糖皮质激素与并发症之间的真实世界关联。

Real-world association between systemic corticosteroid exposure and complications in US patients with severe asthma.

作者信息

Casale Thomas B, Corbridge Thomas, Germain Guillaume, Laliberté François, MacKnight Sean D, Boudreau Julien, Duh Mei S, Deb Arijita

机构信息

Division of Allergy/Immunology, University of South Florida, Tampa, FL, USA.

US Medical Affairs, GSK, Durham, NC, USA.

出版信息

Allergy Asthma Clin Immunol. 2024 Mar 26;20(1):25. doi: 10.1186/s13223-024-00882-y.

DOI:10.1186/s13223-024-00882-y
PMID:38532489
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10964513/
Abstract

BACKGROUND

Systemic corticosteroid (SCS) use remains widespread among patients with severe asthma, despite associated complications.

OBJECTIVE

Evaluate the association between cumulative SCS exposure and SCS-related complications in severe asthma.

METHODS

This retrospective, longitudinal study used claims data from the Optum Clinformatics Data Mart database (GSK ID: 214469). Eligible patients (≥ 12 years old) had an asthma diagnosis and were divided into two cohorts: SCS use and non/burst-SCS use. Patients in the SCS use cohort had a claim for a daily prednisone-equivalent dose ≥ 5 mg SCS following ≥ 6 months of continuous SCS use; those in the non/burst-SCS cohort had no evidence of continuous SCS use and had a non-SCS controller/rescue medication initiation claim. For each cohort, the date of the qualifying claim was the index date. SCS users were further stratified by SCS use during each quarter of follow-up: low (≤ 6 mg/day), medium (> 6-12 mg/day), high (> 12 mg/day), and continuous high (≥ 20 mg/day for 90 days). SCS-related complications were evaluated in the quarter following SCS exposure. The adjusted odds ratios (OR) of experiencing SCS-related complications during follow-up in each of the SCS use groups versus the non/burst SCS cohort were calculated using generalized estimating equations models.

RESULTS

SCS and non/burst-SCS use cohorts included 7473 and 89,281 patients (mean follow-up: 24.6 and 24.2 months), respectively. Compared with the non/burst-SCS use cohort, medium, high, and continuous high SCS use was associated with greater odds of any SCS-related complication (adjusted OR [95% confidence interval]: 1.30 [1.21, 1.39], 1.49 [1.35, 1.64] and 1.63 [1.40, 1.89], respectively) including increased acute gastrointestinal, cardiovascular, and immune system-related complications, and chronic cardiovascular, metabolic/endocrine, central nervous system, bone-/muscle-related, ophthalmologic, and hematologic/oncologic complications. Low-dose SCS use was also associated with significantly increased odds of acute gastrointestinal and immune system-related complications, and chronic bone-/muscle-related and hematologic/oncologic complications versus the non/burst-SCS use cohort.

CONCLUSION

SCS use, even at low doses, is associated with increased risk of SCS-related complications among patients with severe asthma.

摘要

背景

尽管存在相关并发症,但全身用糖皮质激素(SCS)在重度哮喘患者中仍广泛使用。

目的

评估重度哮喘患者中SCS累积暴露与SCS相关并发症之间的关联。

方法

这项回顾性纵向研究使用了Optum临床信息数据集市数据库(GSK ID:214469)中的索赔数据。符合条件的患者(≥12岁)有哮喘诊断,并分为两个队列:使用SCS和未使用/突发使用SCS。使用SCS队列中的患者在连续使用SCS≥6个月后有每日泼尼松等效剂量≥5mg SCS的索赔记录;未使用/突发使用SCS队列中的患者没有连续使用SCS的证据,并有非SCS控制/急救药物起始索赔记录。对于每个队列,符合条件的索赔日期为索引日期。SCS使用者在随访的每个季度中根据SCS使用情况进一步分层:低剂量(≤6mg/天)、中等剂量(>6-12mg/天)、高剂量(>12mg/天)和持续高剂量(≥20mg/天持续90天)。在SCS暴露后的季度中评估SCS相关并发症。使用广义估计方程模型计算每个SCS使用组在随访期间发生SCS相关并发症与未使用/突发使用SCS队列相比的调整后比值比(OR)。

结果

使用SCS和未使用/突发使用SCS队列分别包括7473例和89281例患者(平均随访时间:24.6个月和24.2个月)。与未使用/突发使用SCS队列相比,中等剂量、高剂量和持续高剂量SCS使用与任何SCS相关并发症的更高几率相关(调整后OR[95%置信区间]:分别为1.30[1.21,1.39]、1.49[1.35,1.64]和1.63[1.40,1.89]),包括急性胃肠道、心血管和免疫系统相关并发症增加,以及慢性心血管、代谢/内分泌、中枢神经系统、骨骼/肌肉相关、眼科和血液学/肿瘤学并发症。与未使用/突发使用SCS队列相比,低剂量SCS使用也与急性胃肠道和免疫系统相关并发症以及慢性骨骼/肌肉相关和血液学/肿瘤学并发症的几率显著增加相关。

结论

即使是低剂量使用SCS,也与重度哮喘患者发生SCS相关并发症的风险增加有关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecd7/10964513/eb5cc222d1a5/13223_2024_882_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecd7/10964513/d500ad8cfdcb/13223_2024_882_Fig1_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecd7/10964513/eb5cc222d1a5/13223_2024_882_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecd7/10964513/d500ad8cfdcb/13223_2024_882_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecd7/10964513/d80f4dd1d66d/13223_2024_882_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecd7/10964513/8d4b6b4768d2/13223_2024_882_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecd7/10964513/300f6f0e0a7c/13223_2024_882_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecd7/10964513/eb5cc222d1a5/13223_2024_882_Fig5_HTML.jpg

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