医学
不良事件报告系统
不利影响
吉西他滨
内科学
肿瘤科
化疗
作者
Wei Zhang,Yuhong Wang,Xin Jiang,Huimin Zhao,Xiaoxu Jia,Qiye Wang,Yue Chen,Yuanfang Jiang,Zhifang Ma,Lei Chang,X. Wang
标识
DOI:10.1080/14740338.2023.2284989
摘要
Our research aimed to identify previously undocumented adverse events (AEs) in the gemcitabine drug insert with the goal of informing clinical practice.We extracted adverse events associated with gemcitabine use through 2023 using the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Four algorithms (Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and Empirical Bayesian Geometric Mean) were employed to detect new AE signals. AEs were considered positive signals only if they were detected by all four algorithms.From 2014 to 2023, a total of 42,360 AEs were reported in 14,905 individuals following gemcitabine use. These AEs totaled 437 preferred terms (PTs) across 20 system organ classes (SOCs). We identified unexpected AEs related to the ocular disorders, the nervous system, and the ear and the labyrinth. The ocular organ system will present with retinopathy, purtscher retinopathy, choroidal effusion, amaurosis, necrotizing scleritis, etc. The nervous system may experience reversible posterior encephalopathy syndrome, cerebellar syndrome, cauda equina syndrome, athetosis, transverse myelitis, etc. The ears and labyrinth may exhibit ototoxicity.Our study identified previously undetected signals following gemcitabine treatment, thereby providing new insights for future medication guidance.
科研通智能强力驱动
Strongly Powered by AbleSci AI