与对比介质相关的甲状腺功能障碍:基于FDA不良事件报告系统的现实世界药监测研究
Lu Huang1,2,3, Yan Luo1,2,4, Zhen-Lin Chen3
1Department of Pharmacy, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
对比介质 (ICM) 可以导致甲状腺功能障碍,包括甲状腺功能低下和甲状腺功能过高,通常在服用后30天内. 约迪克桑醇显示最高风险,需要对高风险药物进行甲状腺功能监测.
科学领域:
- 内分泌学 在内分泌学.
- 放射学 放射学是一门学科.
- 药物监督 药物监督 药物监督
背景情况:
- 对比介质 (ICM) 广泛用于医学成像.
- ICM的使用可能会影响甲状腺功能.
- 了解ICM诱导的甲状腺功能障碍的特定风险对于患者的安全至关重要.
研究的目的:
- 分析与ICM相关的甲状腺功能障碍的特征.
- 为了确定构成甲状腺功能障碍风险较高的特定ICM药物.
- 评估ICM相关甲状腺事件的时间关系和严重程度.
主要方法:
- 使用了FDA不良事件报告系统 (FAERS) 数据库.
- 使用不成比例的分析来检测甲状腺功能障碍的安全信号.
- 对报告病例的临床特征进行了描述性分析.
主要成果:
- 确定了83份与ICM相关的甲状腺功能障碍报告.
- 在ICM中,甲状腺功能低下症 (ROR=2.21) 和甲状腺功能过高症 (ROR=3.49) 的报告显著增加.
- 约迪克桑醇在甲状腺功能低下 (ROR=9.47) 和甲状腺功能增强 (ROR=5.44) 两方面都显示出最高的信号.
- 大多数病例发生在ICM给药后的30天内.
- 甲状腺功能障碍症 (12/26) 的严重结局比甲状腺功能障碍症 (2/35) 更频繁.
结论:
- 不同的ICM药物携带着不同的甲状腺功能障碍风险,约迪克桑醇是一个值得关注的关注点.
- 在ICM之后的甲状腺功能障碍通常在第一个月内表现出来.
- 建议在服用后监测甲状腺功能,特别是在高风险的ICM药物中.
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