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与免疫检查点抑制剂相关的胰腺炎:基于FDA不良事件报告系统 (FAERS) 数据库的药监测分析
Lingli Huang1, Haitian Wang2, Nan Wu1
1Department of Pharmacy, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
Frontiers in pharmacology
|October 8, 2025
概括
免疫检查点抑制剂 (ICI) 与胰腺炎的更高风险有关,这是一个严重的不良事件. 监测胰腺炎症状的患者对于及时干预和减少并发症至关重要.
科学领域:
- 在瘤学瘤学.
- 免疫学 免疫学 免疫学
- 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) 可以导致罕见但严重的免疫相关不良事件 (AE).
- 胰腺炎是与ICI治疗相关的显著AE.
- 现实世界的数据分析对于理解ICI相关的胰腺炎至关重要.
研究的目的:
- 调查与ICI相关的胰腺炎的风险和临床概况.
- 分析来自FDA不良事件报告系统 (FAERS) 的现实数据.
- 为了确定具有较高胰腺炎风险的特定ICI及其发病模式.
主要方法:
- 对FAERS数据从2011年第一季度到2024年第三季度的分析.
- 临床特征和结果的描述性分析.
- 使用ROR,PRR,BCPNN和MGPS进行不成比例分析;开始时间 (TTO) 计算.
主要成果:
- 在多个ICI中发现了1166例ICI相关的胰腺炎.
- 在ICI和胰腺炎风险之间发现了显著的关联 (ROR 2.44).
- 杜尔瓦卢马布,蒂塞利祖马布和阿维卢马布的风险最高;中位数的TTO为59天,伊皮利穆马布最短 (37.5天),蒂塞利祖马布最长 (146.5天).
结论:
- ICI与胰腺炎的风险增加显著相关.
- 建议密切监测胰腺炎症状 (例如,腹痛,酶升高).
- 及时干预对于缓解接受ICI的患者并发症至关重要.
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