基于美国FAERS数据库的奥希替尼致肌肉毒性不良事件信号分析

doi:10.19803/j.1672-8629.20240587

摘要/Abstract

摘要： 目的通过对奥希替尼致肌肉毒性不良事件信号进行分析与识别,以期为该药物临床合理用药提供参考。方法提取美国食品药品监督管理局不良事件报告系统（FAERS）数据库2015年第4季度至2023年第4季度奥希替尼不良事件报告,采用报告比值比（Reporting Odds Ratio, ROR）法和比例报告比值比（Proportional Reporting Ratio, PRR）法挖掘奥希替尼致肌肉毒性不良事件的阳性信号。结果共检索到以奥希替尼为首要怀疑的肌肉毒性不良事件报告616份,男女比例为1∶2.87。肌痉挛和肌炎同时符合ROR和PRR的阳性信号标准。结论临床应用奥希替尼时,除关注药品说明书收录的不良反应外,还应密切关注肌肉毒性和性别差异,用药后1个月内建议监测关键指标,以确保患者的用药安全。

关键词: 美国食品药品监督管理局不良事件报告系统, 奥希替尼, 肌肉毒性, 肌炎, 肌痛, 肌酸激酶, 药品不良事件

Abstract: Objective To analyze adverse event (AE) signals related to osimertinib-induced muscle toxicity so as to provide a reference for safe clinical use of this drug. Methods All the data on AE related to osimertinib and collected between the 4th quarter of 2015 and the 4th quarter of 2023 was retrieved from the FDA Adverse Event Reporting System (FAERS) database. Data mining of positive signals of AE related to osimertinib-induced muscle toxicity was performed using the reporting odds ratio (ROR) method and the proportional reporting ratio (PRR) method. Results A total of 616 AE related to muscle toxicity were reported, with osimertinib as the primary suspect (PS). The male-to-female ratio was 2.87. Muscle spasms and myositis met the criteria for positive signals based on both ROR and PRR. Conclusion In clinical use of osimertinib, adverse reactions mentioned in drug instructions, the risk of muscle toxicity and gender differences deserve attention. It is recommended that key indicators be monitored within 30 days of medications with osimertinib to ensure the safety of patients.

Key words: FDA Adverse Event Reporting System(FAERS), Osimertinib, Muscle Toxicity, Myositis, Myalgia, Creatine Kinase, Adverse Drug Events

中图分类号:

陈玲彬, 黄志雄, 郑彩琳, 吴金能, 陈洲. 基于美国FAERS数据库的奥希替尼致肌肉毒性不良事件信号分析[J]. 中国药物警戒, 2025, 22(4): 447-451.

CHEN Lingbin, HUANG Zhixiong, ZHENG Cailin, WU Jinneng, CHEN Zhou. Adverse Event Signals for Osimertinib-Induced Muscle Toxicity Based on FAERS Database[J]. Chinese Journal of Pharmacovigilance, 2025, 22(4): 447-451.

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