使用FDA不良事件报告系统 (FAERS) 评估药物诱导的甲状腺功能障碍风险
Ruixue Li1, Tianqi Liu2, Ting Li3
1Department of Pharmacy, Beijing Hospital; National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences; Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application (Beijing Hospital), Beijing 100730, P.R. China; Department of Pharmacy, Xizang Autonomous Region People's Hospital, Xizang 850000, P.R. China; Department of Pharmacy Administration and Clinical Pharmacy School of Pharmaceutical Sciences, Peking University, Beijing 100191, P.R. China.
这项研究使用FDA数据确定了许多与甲状腺功能障碍 (TD) 相关的药物. 女性性别,特定年龄组和某些药物是药物诱导TD的关键风险因素.
科学领域:
- 药监和药物安全 药监和药物安全
- 内分泌学 在内分泌学.
- 计算流行病学计算流行病学
背景情况:
- 甲状腺功能障碍 (TD) 是一种显著的不良药物反应.
- 识别TD与特定药物关联对于患者安全至关重要.
- 现有的药监系统需要强大的分析方法来检测药物诱导的TD信号.
研究的目的:
- 使用FDA不良事件报告系统 (FAERS) 数据量化药物特异性与甲状腺功能障碍 (TD) 的关联.
- 识别具有显著不成比例信号的药物剂,表明药物诱导的TD.
- 确定与药物相关的TD的独立风险因素和发病时间.
主要方法:
- 利用了FAERS从2004年第一季度到2025年第一季度的数据.
- 采用不成比例分析,包括报告几率比率 (ROR) 和贝叶斯信任传播神经网络 (BCPNN).
- 应用单变量分析,LASSO回归和多变量逻辑回归用于风险因素识别和时间到发病 (TTO) 分析.
主要成果:
- 确定了44317起TD报告,主要是女性 (60.3%),平均年龄为59岁.
- 检测到172种与TD相关的可疑药物;LASSO回归确定了43种独立的风险因素.
- 女性性别,45-59岁年龄组和43种特定药物是独立的风险因素;药物诱导的TTO中位数为34天.
结论:
- 多种药物与甲状腺功能障碍有显著的关联.
- 女性性别,特定年龄的人口统计数据和已识别的药物是药物诱导的TD的独立风险因素.
- 这些发现提高了药物监测和临床意识,以管理药物诱导的甲状腺功能障碍.
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