基于FAERS数据库对泊马度胺不良事件信号的挖掘与分析

目的 基于美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）中的不良事件报告挖掘泊马度胺相关的不良事件信号，为临床安全合理用药提供参考。方法 收集FAERS数据库中泊马度胺2013年2月8日—2024年3月20日的数据，采用报告比值比法（ROR）和贝叶斯可信传播神经网络法（BCPNN）法进行不良事件信号挖掘。结果 最终纳入14 618份有效泊马度胺不良事件报告，得到152个不良事件信号，共累及17个器官系统分类（SOC）。其中男性构成比（50.43%）高于女性（45.03%）；年龄主要分布在60岁以上（56.37%）的人群；累及的SOC主要包括各类检查，呼吸系统、胸及纵隔疾病，血液及淋巴系统疾病，感染及侵染类疾病等；报告数量较多的不良事件信号包括感染性肺炎、中性粒细胞减少症、白细胞计数降低、周围神经病等。泊马度胺说明书中未记载的新的可疑不良反应包括人绒毛膜促性腺激素增加、牙病、心房破裂、克隆性造血、进行性多灶性脑白质病、脑深部核团高敏等。结论 基于FAERS数据库挖掘到的泊马度胺相关不良反应，与药品说明书中提到的基本一致，同时也存在部分新发现的可疑不良反应，在临床用药时应关注。

Signal mining and analysis of pomalidomide adverse events based on FAERS database

Objective To mine the adverse event signals related to pomalidomide based on the adverse reaction reports in the FAERS database, so as to provide references for clinical safe and rational drug use. Methods The data of pomalidomide in FAERS database from February 8, 2013 to March 20, 2024 were collected, and adverse event signal mining was carried out using the method of reported odds ratio (ROR) and Bayesian credible propagation neural network (BCPNN). Results 14 618 effective adverse event reports of pomalidomide were finally included, and 152 adverse event signals were obtained, involving a total of 17 organ system classifications (SOC). The proportion of men (50.43%) was higher than that of women (45.03%). The ages were mainly distributed in people older than 60 years (56.37%), the SOC involved mainly includes various examinations, respiratory system, chest and mediastinal diseases, blood and lymphatic system diseases, infection and infection diseases, etc. A large number of adverse event signals reported include infectious pneumonia, neutropenia, decreased white blood cell count, peripheral neuropathy, etc. New suspicious adverse reactions not recorded in the instructions of pomalidomide include human chorionic gonadotropin increased, tooth disorder, atrial rupture, clonal hematopoiesis, progressive multifocal leukoencephalopathy, and hyperintensity in brain deep nuclei, etc. Conclusion The adverse reactions related to pomalidomide discovered based on the FAERS database are basically consistent with those mentioned in the drug instructions. At the same time, there are also some newly discovered suspicious adverse reactions, which should be paid attention to in clinical medication.