Pan Xianglin, Xiao Xiangtian, Ding Yiling, Shu Yamin, Zhang Wenting, Huang Liu
Department of Pharmacy, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Front Pharmacol. 2024 Jul 9;15:1431579. doi: 10.3389/fphar.2024.1431579. eCollection 2024.
This study aimed to explore the neurological adverse events of oxaliplatin through the Food and Drug Administration Adverse Event Reporting System (FAERS) database and to provide reference for safe clinical drug use.
The adverse events report data of oxaliplatin from the first quarter of 2019 (1 January 2019) to the third quarter of 2023 (30 September 2023) were extracted from FAERS database, and the adverse events signal intensity was determined using the reporting odds ratio, proportional reporting ratio, information component, and empirical Bayes geometric mean methods. Time-to-onset and univariate logistic regression analysis were performed to describe the characteristics and risk factors of oxaliplatin-associated neurological adverse events.
A total of 4,471 cases of oxaliplatin-associated neurological adverse events were identified, with 318 neurological adverse events being documented, among which 87 adverse events satisfied the thresholds of four methodologies. The median time-to-onset of oxaliplatin-associated neurological adverse events was 2 days (interquartile range 0-36 days). Among the factors significantly influencing oxaliplatin-related neurological adverse events, male sex and combination medication decreased the risk of neurological adverse events, while higher cumulative dose increased the risk.
The real-world neurotoxicity spectrum of oxaliplatin and its characteristics and influencing factors were obtained through data mining of FAERS, providing valuable insights for healthcare professionals to effectively manage the risk of neurological adverse events associated with oxaliplatin in clinical practice.
本研究旨在通过美国食品药品监督管理局不良事件报告系统（FAERS）数据库探讨奥沙利铂的神经学不良事件，为临床安全用药提供参考。
从FAERS数据库中提取2019年第一季度（2019年1月1日）至2023年第三季度（2023年9月30日）奥沙利铂的不良事件报告数据，并使用报告比值比、比例报告比、信息成分和经验贝叶斯几何均值法确定不良事件信号强度。进行发病时间和单因素逻辑回归分析，以描述奥沙利铂相关神经学不良事件的特征和危险因素。
共识别出4471例奥沙利铂相关神经学不良事件，记录了318例神经学不良事件，其中87例不良事件满足四种方法的阈值。奥沙利铂相关神经学不良事件的中位发病时间为2天（四分位间距0 - 36天）。在显著影响奥沙利铂相关神经学不良事件的因素中，男性和联合用药降低了神经学不良事件的风险，而累积剂量较高则增加了风险。
通过对FAERS的数据挖掘，获得了奥沙利铂在现实世界中的神经毒性谱及其特征和影响因素，为医疗保健专业人员在临床实践中有效管理与奥沙利铂相关的神经学不良事件风险提供了有价值的见解。
