基于FAERS数据库挖掘曲拉西利的不良事件及分析

目的 基于美国食品药品管理局（FDA）不良事件报告系统（FAERS）收集曲拉西利的不良事件报告，挖掘新的严重的不良事件，为临床安全用药提供参考。方法 获取FAERS中2004年第1季度—2023年第4季度曲拉西利相关的不良事件报告，采取报告比值比法（ROR）、比例报告比值比（PRR）、贝叶斯可信区间递进神经网络（BCPNN）法与多项式伽马泊松分布缩减法（MGPS）联用对不良事件报告进行数据挖掘与分析。结果 共获得与曲拉西利相关的不良事件报告457例次，在已知性别、年龄或地区的不良事件报告中，男女比例相近，45～65岁不良事件报告数占比最大。曲拉西利的不良事件报告涉及19个系统器官分类（SOC），包括全身性疾病及给药部位各种反应、各类检查、精神类疾病等，阳性信号主要包括超说明书使用、骨髓抑制呼吸困难、体力状态下降等。结论 曲拉西利不良事件信号有效与说明书基本一致，同时还发现了一些新的潜在曲拉西利信号，如焦虑、心境抑郁、神经紧张不安等，值得临床关注。

Mining adverse events and analysis of trilaciclib based on FAERS database

Objective To collect adverse drug event reports of trilaciclib based on FAERS database, explore new and serious adverse events, and provide reference for clinical safe drug use. Method Obtaining adverse event reports related to trilaciclib in FAERS from Q1 2004 to Q4 2023, and use a combination of ROR, PRR, BCPNN, and MGPS to mine and analyze adverse event reports. Results A total of 457 adverse drug event reports related to trilaciclib were obtained. Among trilaciclib reports of known gender, age, or region, the male to female ratio was similar, with the highest proportion of ADE reports occurring between the ages of 45 and 65. Adverse drug event report of trilaciclib involves 19 SOC, including systemic diseases and various reactions at the site of administration, various examinations, psychiatric disorders, etc. Positive signals mainly include use beyond the instructions and bone marrow suppression difficulty breathing, decreased physical condition, etc. Conclusion The adverse event signals of trilaciclib are effectively consistent with the instructions, and some new potential signals have been discovered, such as anxiety, mood depression, and nervousness, which are worthy of clinical attention.