在头部和部癌症中对PD-1抗体治疗的药监测评估:使用FAERS数据库进行风险因素分析
Qian Gao1, Linli Xie1, Yu Qin1
1Department of Pharmacy, The First Affiliated Hospital of Army Medical University, Chongqing, China.
Clinical therapeutics
|February 8, 2026
概括
布罗利祖马布和尼沃卢马布,都是用于头癌的PD-1抑制剂,显示出不同的不良事件概况. 临床医生应考虑性别特定的副作用,以确保更安全的患者治疗.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 药物监督 药物监督 药物监督
背景情况:
- 头部和部状细胞癌 (HNSCC) 的治疗选择包括PD-1抑制剂.
- 布罗利祖马布和尼沃卢马布已被批准为HNSCC的PD-1抗体.
- 了解它们的安全性概况对于临床指导至关重要.
研究的目的:
- 在HNSCC中识别和描述与pembrolizumab和nivolumab相关的不良事件 (AE).
- 为了比较这两种PD-1抑制剂的安全性概况.
- 根据AE数据提供基于AE数据的临床指导.
主要方法:
- 从FDA的不良事件报告系统 (FAERS) 中提取了AE报告.
- 分析了pembrolizumab (Q3 2016-Q4 2024) 和nivolumab (Q4 2016-Q4 2024) 的数据.
- 使用报告几率比率 (ROR) 和比例报告比率 (PRR) 来评估AE信号.
主要成果:
- 分析了1562份AE报告:428份用于pembrolizumab,1134份用于nivolumab.
- 布罗利祖马布与11个意想不到的副作用相关;尼沃卢马布与16个相关,包括不同的严重事件.
- 在AE概况中观察到基于性别的显著差异和相似之处.
结论:
- 在HNSCC患者中对PD-1抑制剂AE的现实证据.
- 突出了AE个人资料中基于性别的重要差异.
- 建议临床医生在处方这些治疗时考虑性别特定的副作用.
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