基于FAERS数据库的药物相关性进行性多灶性白质脑病不良事件的挖掘与分析  

Exploration and Analysis of Drug-associated Progressive Multifocal Leukoencephalopathy Adverse Events Based on the FAERS Database

作　　者：谭皓文 欧璇 陈颖[1] TAN Hao-wen;OU Xuan;CHEN Ying(Clinical Drug Trial Institution Office,Wuzhou Red Cross Hospital,Wuzhou Guangxi 543002,China)

机构地区：[1]梧州市红十字会医院药物临床试验机构办公室,广西梧州543002

出　　处：《抗感染药学》2025年第1期33-38,共6页Anti-infection Pharmacy

基　　金：梧州医学高等专科学校2023年度科研项目(编号:23WYKY08);广西卫生健康委西医类科研课题(编号:Z-D20231663)。

摘　　要：目的:基于美国FDA不良事件报告系统(FDA Adverse Event Reporting System,FAERS)数据库,挖掘和分析药物相关性进行性多灶性白质脑病(progressive multifocal leukoencephalopathy,PML)的流行病学特点,为相关药物的用药安全提供参考。方法:在FAERS数据库中,检索2004-2022年期间首选术语为(preferred term,PT)为“progressive multifocal leukoencephalopathy”(PT代码为10036807)的不良事件(adverse events,AE),采集首要怀疑药物(primary suspect drug,PS),分析这些药物相关性PML的流行病学特点。结果:在FAERS数据库中,共检索到药物相关性PML的AE报告6604份,其中报告数前30位的PS涉及的AE报告有5063份;在5063份AE报告中,患者多为女性(2588例,占51.12%),年龄上主要集中于18~<65岁(2829例,占55.88%),临床结局中死亡的达1605例(占31.70%);报告数前30位的PS中,药物的种类主要为抗肿瘤药(14种,占46.67%)和免疫抑制剂(11种,占36.67%),而报告数最多的PS分别为那他珠单抗(1826例,占36.07%)和利妥昔单抗(1271例,占25.10%),并且其报告比值比亦是最高(分别为43.31和29.13)。结论:药物相关性PML有着较高的死亡风险,其PS主要为那他珠单抗和利妥昔单抗,对于使用这2种药物的患者,临床应加强用药安全监测,以便AE发生时患者能得到及时的救治。Objective:Based on the FDA Adverse Event Reporting System(FAERS)database,to explore and analyze the epidemiological characteristics of drug-associated progressive multifocal leukoencephalopathy(PML),and provide reference for the medication safety of related drugs.Methods:Adverse events(AEs)with the preferred term(PT)of"progressive multifocal leukoencephalopathy"(PT code:10036807)during the period from 2004 to 2022 were searched in the FAERS database.Primary suspect drugs(PS)were collected,and the epidemiological characteristics of these drug-associated PML were analyzed.Results:In the FAERS database,a total of 6604 AEs of drug-associated PML were retrieved,among which 5063 AEs were involved in the top 30 PS reports.Among 5063 AEs,most of the patients were female(2588 cases,51.12%),the age was mainly concentrated in 18 to below 65 years old(2829 cases,55.88%),and the clinical outcome was 1605 death cases(31.70%).Among the top 30 PS reported,the main categories of drugs were antitumor agents(14,46.67%)and immunosuppressants(11,36.67%),while natalizumab(1826 cases,36.07%)and rituximab(1271 cases,25.10%)were the mostly reported PS respectively,with the highest reporting odds ratio(43.31 and 29.13 respectively).Conclusion:Drug-associated PML has a high risk of death,and its PS mainly includes natalizumab and rituximab.For patients using these two drugs,clinical medication safety monitoring should be strengthened so that patients can receive timely treatment in case of AE.

关 键 词：药物相关性进行性多灶性白质脑病 FAERS 不良事件 流行病学特点 用药安全 

分 类 号：R961[医药卫生—药理学]