与PD-1/PD-L1抑制剂相关的内分泌系统相关的不良事件:来自FDA不良事件报告系统的数据挖掘
Hongxia Shi1, Yunhua He1, Siyuan Dan1
1Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, China.
Frontiers in medicine
|May 7, 2024
概括
免疫检查点抑制剂,如PD-1/PD-L1疗法,可以引起严重的内分泌副作用,特别是在65岁以上的男性中. 这些不良事件虽然迟到,但需要仔细监测和注意,特别是在特定药物.
科学领域:
- 在瘤学瘤学.
- 免疫学 免疫学 免疫学
- 内分泌学 在内分泌学.
背景情况:
- 免疫检查点抑制剂,包括编程细胞死亡蛋白-1 (PD-1) 和其连接体 (PD-L1),是广泛使用的癌症疗法.
- 这些疗法虽然有效,但与影响内分泌腺体的显著副作用有关.
研究的目的:
- 分析与PD-1/PD-L1抑制剂相关的内分泌系统相关不良事件 (AE) 的发生率和特征.
- 确定特定的药物和患有这些内分泌AEs风险较高的患者人群.
主要方法:
- 利用FDA不良事件报告系统 (FAERS) 数据库从2019年第一季度到2023年第一季度的报告.
- 员工报告的几率比率 (ROR) 和综合标准 (MHRA) 方法用于数据挖掘和分析不良事件报告.
主要成果:
- 收集了5322个内分泌系统的副作用 (占报告总数的6.68%),其中布罗利祖马布和尼沃卢马布占多数.
- 内分泌AE在65岁以上的男性中更为普遍,并且涉及甲状腺,垂体和上腺.
- 副作用发生的平均发病时间为61天,导致长时间住院 (> 40%) 和严重病例死亡 (> 10%),特别是在pembrolizumab,nivolumab和durvalumab.
结论:
- 65岁及以上的男性患PD-1/PD-L1抑制剂引起的内分泌AE的风险增加.
- 在开始治疗和内分泌AEs的出现之间存在很大的延迟,这可能会产生严重的后果.
- 密切监测内分泌AEs至关重要,特别是对于接受pembrolizumab,nivolumab或durvalumab的患者.
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