免疫检查点抑制剂诱导的甲状腺功能障碍发病时间的性别差异:JADER不成比例性分析
Naohito Ide1, Yuki Tsuruta1, Ken-Ichi Sako2
1Department of Practical Pharmacy, Nihon Pharmaceutical University, Saitama, Japan.
Expert opinion on drug safety
|January 19, 2026
概括
免疫检查点抑制剂 (ICI) 可以导致甲状腺功能障碍. 这项研究发现,ICI诱导的甲状腺功能障碍在女性患者中较早发生,强调需要对性别特定的监测.
科学领域:
- 在瘤学瘤学.
- 内分泌学 在内分泌学.
- 药物监督 药物监督 药物监督
背景情况:
- 免疫检查点抑制剂 (ICI) 在癌症治疗中至关重要,但可能导致甲状腺功能障碍.
- 已知ICI诱导的甲状腺功能障碍 (ICI-TD) 的发生率,但其发病时间和性别差异尚不清楚.
研究的目的:
- 调查与特定ICI (尼沃卢马布,潘布罗利祖马布,伊皮利穆马布) 相关的甲状腺功能障碍发生的时间.
- 探索ICI-TD发病时间的潜在性别差异.
主要方法:
- 利用日本药物不良事件报告 (JADER) 数据库来识别ICI-TD病例.
- 采用标准化的MedDRA查询来识别病例,并计算报告概率比率.
- 通过韦布尔分布和曼-惠特尼U测试进行了时间到发病分析,按性别分层.
主要成果:
- 在研究的药物中确定了大量ICI-TD病例.
- 甲状腺功能障碍症的中位发病时间在33至44.5天之间,甲状腺功能障碍症的中位发病时间在60至85天之间.
- 与男性相比,女性患者的ICI-TD发病时间始终较短.
结论:
- ICI诱导的甲状腺功能障碍在女性患者中表现得更早.
- 在接受ICI治疗的患者中,针对性别的监测策略对于早期检测和治疗甲状腺相关不良事件至关重要.
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