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Yuxuan Gao¹, Shiyao Jiang², Yu Cui²

¹Department of Public Health, Shandong Second Medical University, Weifang, Shandong, China.

|January 9, 2026

概括

免疫检查点抑制剂 (ICI) 可以导致不可逆转的内分泌免疫相关不良事件 (irAEs). 这项研究在50岁以上的男性中发现了更高的irAEs,突出显示了甲状腺功能障碍和上腺功能不充分等风险.

科学领域:

药监和药物安全药监和药物安全
瘤学和免疫学
内分泌学在内分泌学.

背景情况:

免疫检查点抑制剂 (ICI) 广泛用于癌症治疗.
免疫相关的不良事件 (irAEs) 是常见的,但内分泌的irAEs由于不可逆转和非特异性症状,存在诊断挑战.

研究的目的:

使用药监数据调查与PD-1/PD-L1抑制剂相关的内分泌IRAE.
在包括亚洲人群在内的多个数据库中系统验证内分泌irAEs.
为了识别新的安全信号,并告知更新的药物标签.

主要方法:

利用美国食品和药物管理局的不良事件报告系统 (FAERS) 和日本不良药事件报告 (JADER) 数据库.
进行了一项跨数据库调查,重点关注由PD-1/PD-L1抑制剂诱导的内分泌irrAEs.
分析了报告变化,并确定了人口统计学模式.

主要成果:

在接受PD-1/PD-L1抑制剂的50岁以上男性中,内分泌IRAE更为普遍.
在PD-1/PD-L1抑制剂和甲状腺功能障碍,上腺功能不全和垂体炎症之间发现了强烈的关联.
发现了几种以前未经记录的内分泌IRAE,这表明了新的安全信号.

结论:

PD-1/PD-L1抑制剂与显著的内分泌IRAEs有关,需要更新安全标签.
跨数据库验证,包括通过JADER对亚洲人群的验证,增强了全球药物监督.
需要对非标签用途进行进一步的临床试验,以评估有效性和安全性.

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