免疫检查点抑制剂相关的胃肠道不良事件:基于FAERS数据库的不成比例分析
Yuye Gao1, Junpeng Pei1, Dengbo Ji1
1State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research, Unit III, Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute, Beijing, China.
Expert opinion on drug safety
|October 13, 2025
概括
免疫检查点抑制剂 (ICI) 增加胃肠道不良事件 (GI AEs),特别是在抗CTLA-4疗法时. 先进的疾病和组合治疗增加了这种风险,需要个性化患者护理策略.
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:
- 免疫检查点抑制剂 (ICI) 已经改变了癌症治疗.
- 胃肠道免疫相关不良事件 (GI AEs) 是ICI的常见和严重并发症.
- 了解胃肠道副作用的风险因素对于患者的治疗结果至关重要.
研究的目的:
- 为了识别和描述与ICI治疗相关的GIAE.
- 分析影响ICI相关GIAE发展的因素.
- 评估ICI类型和患者特征对GI毒性的影响.
主要方法:
- 使用FDA不良事件报告系统 (2011-2024) 进行回顾性药监测研究.
- 不成比例分析 (ROR,PRR,BCPNN,MGPS) 用于AE的识别.
- 多变量逻辑回归和贝叶斯网络建模用于风险因素分析.
主要成果:
- 确定了85种不同的胃肠道毒性作为ICI相关的GIAE.
- 抗CTLA-4疗法显示出最高的毒性 (ROR=17.76).
- 疾病阶段,并发向疗法和ICI类型显著影响了GIAE风险;胃水出血的死亡率高 (63.64%).
结论:
- ICI治疗,特别是抗CTLA-4治疗,具有高GIAE的风险.
- 第四期疾病,并发向疗法和组合ICI疗法增加了GIAE风险.
- 个性化治疗策略对于减轻ICI诱导的胃肠道毒性至关重要.
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