在FAERS数据库 (2014-2024) 中的ramucirumab的真实世界不良事件模式:一个全面的药监测研究研究
Yi Dong1, Tianjun Feng1, Xu Zhang2
1Harbin Medical University Cancer Hospital, 150 Haping Road, Harbin, 150081, China.
Naunyn-Schmiedeberg's archives of pharmacology
|February 10, 2026
概括
拉慕西鲁马布是一种VEGFR-2抑制剂,具有已知的毒性和新的安全问题,如心力衰竭. 警监测至关重要,特别是在固体瘤治疗的早期.
科学领域:
- 在瘤学瘤学.
- 药物监督 药物监督 药物监督
- 临床药理学 临床药理学
背景情况:
- 拉穆西鲁马布是一种向VEGFR-2的单克隆抗体,用于治疗各种固体瘤.
- 其现实世界的安全性需要在临床试验之外进一步阐明.
研究的目的:
- 在常规临床实践中全面分析拉穆西鲁马布的不良事件报告.
- 为了识别与拉穆齐鲁马布治疗相关的已知和以前未被认可的安全信号.
主要方法:
- 从FAERS数据库 (2014-2024) 中分析了3,435个非重复的不良事件报告.
- 利用四种不成比例的方法来识别重要的安全信号 (139个首选术语).
主要成果:
- 已确认的已知毒性:胃肠道穿孔,出血,高血压,蛋白尿.
- 检测到未被认可的事件:心力衰竭,胆胸,伪.
- 胃肠道穿孔是常见的,通常发生在拉穆西鲁马布治疗的前三个月内.
结论:
- 拉穆齐鲁马布治疗的早期阶段对于严重不良事件的发生至关重要.
- 调查结果强调需要加强患者监测,并进一步研究拉穆西鲁马布的安全风险.
- FAERS数据表明潜在的未被认可的安全问题需要临床关注.
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