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基于FAERS数据库的etrasimod治疗性结肠炎的安全性评估

Qian Guo¹, Meirong Shan², Wei Gao³

¹Department of Rhinology, The First Affiliated Hospital of Zhengzhou University, No.1 Jianshe East Road, Zhengzhou, 450052, Henan, China.

Scientific reports

|October 21, 2025

概括

这项研究分析了FDA的数据,以评估etrasimodimod.

科学领域:

药物监督药物监督药物监督
胃肠病学胃肠病学
药品安全药品安全

背景情况:

埃特拉西莫德是一种用于性结肠炎 (UC) 的斯芬戈-1-酸盐 (S1P) 受体调节剂.
有限的现实世界数据存在于UC患者中埃特拉西莫德的不良事件 (AEs).
临床应用需要全面的安全评估.

研究的目的:

评估埃特拉西莫德在性结肠炎 (UC) 患者中的真实安全性.
为了识别和表征与埃特拉西莫德治疗相关的不良事件 (AE).
为在etrasimod.com上管理UC患者的临床医生提供基于证据的见解.

主要方法:

使用FDA不良事件报告系统 (FAERS) 数据库进行数据分析.
使用不成比例分析,包括ROR,PRR,BCPNN和MGPS,以检测安全信号.
分析了自2004年以来埃特拉西莫德所有报告的副作用.

主要成果:

在多个系统器官类 (SOC) 中确定了显著的积极安全信号.
主要受影响的SOC包括胃肠道疾病,眼睛疾病和代谢/营养障碍.
发现了以前未报告的副作用,如头痛,头,疲劳,腹和视力模糊.

结论:

埃特拉西莫德在各种器官系统中表现出明显的AEs安全性.
现实世界的数据显示了目前药物标签上没有列出的潜在的副作用.
这些发现对于临床医生来说至关重要,以优化UC管理中的患者安全和治疗结果.

关键词:

不成比例的分析分析.埃特拉斯莫迪莫德 (Etrasimod) 是一种公平的人是公平的.性结肠炎是一种

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