基于FAERS的索托拉西布不良事件信号挖掘分析

Signal Detection Analysis of Sotorasib Adverse Events Based on FAERS

目的 研究旨在挖掘索托拉西布不良事件(AE)风险,提供临床安全参考。方法 从美国食品药品监督管理局的AE报告系统数据库中收集2021年第一季度至2023年第二季度的索托拉西布AE报告,使用报告比值比法挖掘风险信号。结果 共提取6553918例AE报告,主要怀疑药物为索托拉西布的有1599例。常见AE包括腹泻、死亡、疾病进展、疲劳、恶心、肝毒性、肝功能检测结果升高等。可能新的AE风险信号包括便秘、肺栓塞、嗜睡、脑血管意外等。结论 索托拉西布的临床使用需加强监测,确保患者用药安全,尤其要关注便秘、肺栓塞、嗜睡、脑血管意外等情况。

OBJECTIVE This study aims to explore the risk of adverse events(AE)associated with sotorasib and provide clinical safety insights.METHODS We colss Event Reporting System database for the first quarter of 2021 to the second quarter of 2023.AE risk signals were explored using the reporting odds ratio method.RESULTS A total of 6,553,918 AE reports were extracted,with 1,599 reports primarily implicating sotorasib as the suspected drug.Common AEs included diarrhea,death,disease progression,fatigue,nausea,liver toxicity,and elevated liver function test results.Potential new AE risk signals included constipation,pulmonary embolism,somnolence,and cerebrovascular accidents.CONCLUSION Clinical monitoring of sotorasib usage should be intensified to ensure patient safety.Particular attention should be paid to preventing constipation,pulmonary embolism,somnolence,and cerebrovascular accidents.