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非感染性中间葡萄膜炎、后葡萄膜炎或全葡萄膜炎患者口服糖皮质激素暴露与相关并发症风险增加:真实世界数据分析

Oral corticosteroid exposure and increased risk of related complications in patients with noninfectious intermediate, posterior, or panuveitis: Real-world data analysis.

作者信息

Chirikov Viktor V, Shah Ruchit, Kwon Youngmin, Patel Dipen

机构信息

a Real-World Evidence , Pharmerit International , Bethesda , MD , USA.

出版信息

Ophthalmic Epidemiol. 2019 Feb;26(1):27-46. doi: 10.1080/09286586.2018.1513042. Epub 2018 Sep 10.

Abstract

PURPOSE

This study causally examined the dose-response relationship between oral corticosteroids (OCS) exposure and long-term complications among noninfectious uveitis adult patients in the United States.

METHODS

The study design was longitudinal, retrospective cohort using Truven Health MarketScan claims database years 2000-2015. The index date was the first day after diagnosis on which OCS≥ 5 mg prednisone equivalent was administered. The period following the index date was parsed into quarters for tracking OCS-related complications; follow-up time was censored when patients switched off of OCS monotherapy. Each quarter of follow-up was divided into 4 groups based on the mean cumulative daily OCS dose (< 7.5 mg; 7.5 to < 30 mg; 30 to < 60 mg; and ≥ 60 mg) and covariate balancing propensity scoring was used to balance groups on baseline characteristics in the first quarter post-index. Marginal structural models (MSMs) were employed to account for time-varying endogeneity between temporal changes in mean cumulative OCS dose and the risk of complications. Patients with systemic autoimmune conditions at baseline were excluded.

RESULTS

The study sample included 3966 patients with a median follow-up of 2 years. Compared to those receiving < 7.5 mg, patients with higher mean cumulative OCS dose had 10%, 16%, and 28% higher risk, respectively, of any OCS-related complication in any given quarter.

CONCLUSIONS

A moderate dose-response relationship was found between the long-term use of OCS monotherapy and the risk of developing complications in noninfectious intermediate, posterior, or panuveitis patients. Future research should examine optimal approaches to achieve inflammation control while minimizing OCS exposure.

摘要

目的

本研究对美国非感染性葡萄膜炎成年患者口服糖皮质激素(OCS)暴露与长期并发症之间的剂量反应关系进行了因果分析。

方法

本研究设计为纵向回顾性队列研究,使用2000 - 2015年Truven Health MarketScan索赔数据库。索引日期为诊断后首次给予≥5mg泼尼松等效剂量OCS的日期。索引日期后的时间段按季度划分以追踪与OCS相关的并发症;当患者停止OCS单药治疗时,随访时间进行截尾。基于平均每日累积OCS剂量(<7.5mg;7.5至<30mg;30至<60mg;以及≥60mg),将每个随访季度分为4组,并使用协变量平衡倾向评分在索引后第一季度对各组的基线特征进行平衡。采用边际结构模型(MSM)来解释平均累积OCS剂量的时间变化与并发症风险之间的时变内生性。排除基线时患有全身性自身免疫性疾病的患者。

结果

研究样本包括3966名患者,中位随访时间为2年。与接受<7.5mg剂量的患者相比,平均累积OCS剂量较高的患者在任何给定季度发生任何与OCS相关并发症的风险分别高10%、16%和28%。

结论

在非感染性中间、后部或全葡萄膜炎患者中,发现长期使用OCS单药治疗与发生并发症的风险之间存在中度剂量反应关系。未来的研究应探讨在控制炎症的同时尽量减少OCS暴露的最佳方法。

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