皮质类固醇在炎症性肠病中使用的不良事件负担的差异,根据不良事件报告系统和患者调查问卷的报道
Eman Al Sulais1, Edouard Louis2, Bernd Bokemeyer3
1Department of Gastroenterology, Addenbrooke's Hospital, Cambridge University Hospitals, Cambridge, UK.
Journal of Crohn's & colitis
|September 7, 2024
概括
在炎症性肠病 (IBD) 中使用皮质类固醇是常见的,患者报告影响生活质量的不良事件 (AE). 临床医生根据客观标准不成比例地报告了AE,突出了了解AE全部负担的差距.
科学领域:
- 药物监督 药物监督 药物监督
- 胃肠病学 胃肠病学
- 临床治疗学 临床治疗学
背景情况:
- 皮质类固醇是炎症性肠病 (IBD) 的标准治疗方法.
- 与IBD患者的皮质类固醇治疗相关的不良事件 (AEs) 的全谱尚未完全理解.
- 目前对IBD中皮质类固醇相关的副作用的知识有限,特别是在患者报告的结果方面.
研究的目的:
- 在患有炎症性肠病 (IBD) 的患者中,全面评估与皮质类固醇使用相关的不良事件 (AE) 的负担.
- 将药监数据库中报告的副作用与患者回忆的副作用进行比较.
- 为了确定在IBD管理中不成比例地与皮质类固醇相关的特定AE.
主要方法:
- 从FAERS和VigiBase数据库中提取了prednisone/prednisolone和budesonide的AE报告.
- 表格化总和频繁报告的AE,使用比例报告比率比较特别感兴趣的AE.
- 将数据库报告与患者在专门调查中回忆起的副作用进行了比较.
主要成果:
- 在FAERS报告中报告了344,000多例AE,在IBD患者的VigiBase报告了42,000多例AE;3.0%和26.6%的AE分别与普雷尼松/普雷尼索隆和布索尼德有关.
- 不成比例地报告的副作用包括上腺功能不充分,Cushingoid并发症,骨髓缩,骨质疏松症,糖尿病和胰腺炎.
- 暴露于普德尼松的患者回忆的副作用比布德胺 (27.4%) 更多 (61.9%),通常回忆的副作用包括体重增加,睡眠问题,情绪变化和皮肤变化,与数据库报告不同.
结论:
- 与IBD的皮质类固醇治疗相关的不良事件很常见.
- 患者报告的副作用显著影响生活质量.
- 临床医生在数据库中报告的副作用与患者经历和回忆的副作用之间存在差异.
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