癌症患者的免疫检查点抑制剂与肝炎相关的不良事件:使用FAERS数据库的观察性,回顾性,药监测研究

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Zhiwen Fu¹, Jinmei Liu¹, Cong Zhang¹

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概括

免疫检查点抑制剂 (ICI) 与严重的免疫相关不良事件有关,特别是自身免疫性肝炎,免疫媒介性肝炎和 fulminant 肝炎. 对于管理ICI治疗患者的医疗保健提供者来说,提高警至关重要.

科学领域:

药物监督药物监督药物监督
免疫学免疫学免疫学
肝病学肝病学是一种肝病学.

背景情况:

免疫检查点抑制剂 (ICI) 是标准的癌症治疗方法.
ICI可以引起与免疫相关的不良事件 (irAEs),包括与肝炎相关的不良事件 (HRAEs).
确定与ICI相关的特定HRAE对于患者安全至关重要.

研究的目的:

识别和描述与ICI使用显著相关的HRAE.
分析与ICI相关的HRAE中的模式的现实数据.
在接受ICI的患者中,为临床实践提供有关HRAE风险的信息.

主要方法:

使用FDA不良事件报告系统数据 (2004-2023) 进行观察性,回顾性药监测研究.
使用Frequentist (ROR) 和贝叶斯 (IC) 方法的不成比例分析.
对接受抗PD-1,抗PD-L1和抗CTLA-4抗体治疗的患者的HRAE报告的分析.

主要成果:

在ICI和自身免疫性肝炎,免疫媒介性肝炎和性肝炎之间发现了显著的关联.
受影响患者的中位年龄为63岁,死亡率为24.9%.
抗PD-1/PD-L1疗法显示免疫媒介性肝炎的发病率高于抗CTLA-4;双重ICI疗法增加了HRAE报告.

结论:

治疗ICI与严重HRAE的显著风险有关,包括自身免疫性肝炎,免疫媒介性肝炎和 fulminant肝炎.
医疗保健提供者必须保持对这些风险的高度认识.
现实世界数据分析证实,需要监测和主动管理ICI患者的HRAE.

关键词:

在FAERS数据库中,我们可以找到FAERS数据库.不成比例性分析分析肝炎肝炎是什么意思肝炎肝炎是什么意思免疫检查点抑制剂免疫检查点抑制剂药监测研究研究药监测研究

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