基于FAERS数据库的信号挖掘和tisotumab vedotin不良事件的风险分析
JuanJuan Li1, Yang Zhao1, Xueqin Yang1
1Department of Pharmacy, Guangyuan Central Hospital, Guanyuan, China.
Scientific reports
|August 18, 2025
概括
抗体-药物结合物tisotumab vedotin (TV) 在宫癌患者中显示了真实世界的不良事件 (AE). 眼睛和血液/淋巴系统疾病最常见,发现了白内障等新信号.
科学领域:
- 在瘤学瘤学.
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
背景情况:
- 提索托马布维多丁 (TV) 是一种被批准用于治疗复发性或转移性子宫癌的抗体药物联合体 (ADC).
- 关于电视的不良事件 (AE) 的临床试验数据有限;需要现实世界的证据.
- 了解现实世界中的AEs对于安全有效的电视使用至关重要.
研究的目的:
- 使用FDA不良事件报告系统 (FAERS) 分析与tisotumab vedotin相关的现实世界AE.
- 识别显著的AE信号并将其与现有的临床试验数据进行比较.
- 为在电视治疗中管理宫癌患者的临床医生提供最新的安全信息.
主要方法:
- 对FAERS数据库对2021年7月至2024年9月的电视相关AE报告进行回顾性分析.
- 使用四种统计算法 (ROR,PRR,IC,EBGM) 来评估AE信号强度.
- 专注于系统器官类 (SOC) 和个人AE报告.
主要成果:
- 眼睛疾病 (ROR=11.53) 和血液/淋巴系统疾病 (ROR=2.31) 与电视显著相关.
- 周围神经病变 (ROR=23.03) 是最常见的AE;symblepharon (ROR=1094.23) 显示了最强的信号.
- 新的安全信号包括白内障 (ROR=8.8) 和史蒂文斯-约翰逊综合征 (ROR=9.91).
- 平均AE发病时间为21天,大多数发生在第一个月内.
结论:
- 现实世界的数据显示,电视和眼睛/血液/淋巴细胞间存在显著的关联,包括以前未报告的信号.
- 这些发现补充了临床试验数据,强调了监测特定AE的重要性,如外围神经病变,symblepharon,白内障和SJS.
- 这项分析为优化电视的临床应用和宫癌治疗中的患者安全提供了宝贵的见解.
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