立方体使用和管间炎的风险:使用FDA不良事件报告系统进行现实世界的信号检测分析

Ayesha Yasmeen^1,2, Mamoon H Syed^1,2, Amani Khardali^1,2

¹Department of Clinical Practice, College of Pharmacy, Jazan University, Jazan, Saudi Arabia.

Frontiers in medicine

|November 27, 2025

概括

类药物可能与管间炎 (TIN) 相关,这是一种脏疾病,特别是在老年人中. 现实数据显示,他类药物相关的TIN的安全信号越来越大,需要进行临床考虑.

科学领域:

药监和药物安全药监和药物安全
腎臟病學 (nephrology) 是一種醫學專業.
心血管医学心血管医学

背景情况:

类药物通常用于预防心血管疾病.
对于他类药物的不良影响是令人担忧的,包括罕见的管介质炎 (TIN) 报告.
现实世界的数据对于评估药物安全信号至关重要.

研究的目的:

调查他类药物使用与管间炎 (TIN) 之间的潜在关联.
分析药监数据以检测与他类药物相关的TIN的安全信号.
评估随着时间的推移与他类药物相关的TIN报告的趋势.

主要方法:

对美国FDA不良事件报告系统 (FAERS) 2017-2024年数据的分析.
使用MedDRA首选术语识别TIN案件.
不成比例分析 (ROR,PRR,EBGM,IC) 以检测安全信号,分层分为COVID-19之前和之后的时期.

主要成果:

确定了120例与他类药物使用相关的TIN病例.
从2021年开始,与他类药物相关的TIN出现了显著的安全信号,在2024年达到顶峰.
大多数受影响的患者年龄≥60岁,超过65%需要住院治疗.

结论:

现实数据表明,他类药物使用与TIN之间存在统计学上显著的关联,特别是在老年人中.
临床医生应考虑在接受他类药物治疗的患者中使用TIN,患者有不明原因的功能障碍.
需要进一步的研究来证实这种关联,并确定风险因素.

关键词:

药物不良反应报告系统药物监管监督是指对药物进行监督.基甲基谷氨基-CoA减少酶抑制剂药物监督和药物监督在营销后的营销过程中.管腔间歇性炎管腔间歇性炎

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