同时使用皮质类固醇对性结肠炎临床试验中的不良事件的影响
Hasan Hamam1, Parambir S Dulai2, John K Marshall1
1Department of Medicine (Division of Gastroenterology) and Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON, Canada.
Journal of Crohn's & colitis
|August 12, 2025
概括
在性结肠炎 (UC) 临床试验中使用皮质类固醇与更多不良事件 (AE) 有关. 减少对皮质类固醇的依赖可能会降低UC患者的AE率.
科学领域:
- 胃肠病学 胃肠病学
- 临床药理学 临床药理学
- 药品安全 药品安全
背景情况:
- 在晚期性结肠炎 (UC) 治疗中,不良事件 (AEs) 是常见的.
- 同时使用皮质类固醇对UC试验中AE率的影响还不清楚.
研究的目的:
- 在UC临床试验中调查皮质类固醇使用与AE发病率增加之间的关联.
主要方法:
- 从多个安慰剂控制的UC试验中对参与者级数据进行后期分析.
- 评估了基线和持续使用皮质类固醇和AE总率之间的关联.
- 检查了在患者中实现无皮质类固醇缓解的AE率,与没有实现缓解的患者相比.
主要成果:
- 皮质类固醇使用者在一年内与非使用者相比 (67.6%) 经历了更高的AE发病率 (75.2%).
- 基线上皮质类固醇的使用是AEs (OR 1.5) 的独立风险因素.
- 一年内持续使用皮质类固醇显著增加了AE风险 (OR 4.6).
结论:
- 在UC临床试验中,皮质类固醇的使用独立地与较高的不良事件负担有关.
- 逐渐减少和监测皮质类固醇的策略对于减轻AE风险至关重要.
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