与免疫检查点抑制剂相关的细胞因子释放综合征:基于FAERS中自发报告的药监测研究
Xin Xi1, Xida Yan2, Ying Chen3
1Department of Pharmacy, The Third Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Expert opinion on drug safety
|July 25, 2024
概括
免疫检查点抑制剂 (ICI) 可以引起细胞因子释放综合征 (CRS),这是一个重要的免疫相关不良事件. 这项研究分析了FAERS数据,发现尼沃卢马布和伊皮利穆马布等组合疗法显示出最高的CRS风险.
科学领域:
- 免疫学 免疫学 免疫学
- 在瘤学瘤学.
- 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) 已经彻底改变了癌症治疗.
- 细胞因子释放综合征 (CRS) 是一种与ICI相关的显著免疫相关的不良事件.
- 了解ICI相关的CRS的发生率和风险因素对于患者安全至关重要.
研究的目的:
- 在接受免疫检查点抑制剂 (ICI) 治疗的患者中表征细胞因子释放综合征 (CRS).
- 分析来自FDA不良事件报告系统 (FAERS) 的不良事件报告,用于ICI相关的CRS.
- 使用不成比例分析量化特定ICI和CRS之间的关联.
主要方法:
- 从FAERS (2011年1月至2023年9月) 获取ICI不良事件报告.
- 使用医学监管活动词典 (MedDRA) 首选术语识别了CRS的确诊病例.
- 使用报告几率比率 (ROR) 方法来评估ICI和CRS之间的关联.
主要成果:
- 分析了395个ICI相关的CRS病例.
- 肺癌和皮肤癌是最常见的相关恶性瘤.
- 组合疗法,特别是尼沃卢马布和伊皮利穆马布,显示了最高的CRS风险 (ROR = 11.95).
- 中位时间到CRS发作为14天.
结论:
- 与ICI相关的CRS是癌症免疫治疗中的新兴和重大不良事件.
- 这一分析为医疗保健专业人员提供了关于ICI相关CRS风险概况的宝贵见解.
- 对于接受ICI的患者来说,早期识别和管理CRS是必不可少的.
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