基于FAERS数据库的普乐沙福不良事件信号挖掘与研究  

Research and Signal Mining of Adverse Drug Events of Plerixafor Based on FAERS Database

作　　者：张莲卿 杨提 李文艳[2] 朱海斌 ZHANG Lian-qing;YANG Ti;LI Wen-yan;ZHU Hai-bin(Department of Pharmacy,Changhai Hospital,Naval Military Medical University,Shanghai 200433,China;Department of Clinical Pharmacology,Shanghai Pudong New Area Gongli Hospital,Shanghai 200135,China;Department of Pharmacy,Yangpu Hospital,School of Medicine,Tongji University,Shanghai 200090,China)

机构地区：[1]中国人民解放军海军军医大学第一附属医院药学部,上海200433 [2]上海市浦东新区公利医院临床药学部,上海200135 [3]上海市杨浦区中心医院药剂科,上海200090

出　　处：《海峡药学》2024年第9期105-109,共5页Strait Pharmaceutical Journal

基　　金：上海市浦东新区卫健委重点学科PWZxk2022-26。

摘　　要：目的利用美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)挖掘普乐沙福不良事件(ADE)风险信号,为临床安全用药提供参考。方法检索FAERS数据库中2009年1月1日~2023年3月31日的ADE报告数据,以“普乐沙福”为目标药物,检索关键词为“plerixafor”及“Mozobil”。采用WPS表格统计患者基本信息,包括性别、ADE上报人员和上报国家、ADE严重程度和类型等。采用《ICH国际医学用语词典》(MedDRA)中的首选系统器官分类(SOC)和首选术语(PT)对ADE进行描述、分类和统计。采用比值失衡测量法中的报告比值比法(ROR)和综合标准法(MHRA)对普乐沙福ADE报告进行数据挖掘。结果共检索到普乐沙福ADE报告488份,涉及26个SOC,其中有595例次严重ADE。上报人员以医务人员为主(43.65%),上报国家以美国为主(58.40%)。采用ROR法和MHRA法共获得69个ADE风险信号,包括暗夜恐怖、游离血红蛋白检出、尿胆红素升高等新发不良反应。结论临床在使用普乐沙福时,应注意血小板减少、过敏反应等严重不良反应,还应关注暗夜恐怖、感染、尿胆红素升高等风险,确保患者用药安全。OBJECTIVE To access the database of Food and Drug Administratio n Adverse Events Reporting System(FAERS)to mining risk signals of adverse drug events(ADE)of plerixafor,so as to provide references for drug safety in clin ical practices.METHODS The ADE reports from January 1,2009 to March 31,2023 in FAERS database were retrieved and analyzed.With plerixafor a s the target drug,the search keywords were“plerixafor”and“Mozobil”.The WPS form was used to count the basic information of patients,including gender,ADE reporting personnel and reporting country,ADE severity and type,etc.The p referred system organ classification(SOC)and preferred term(PT)in the Medica l Dictionary for Regulatory Activities(MedDRA)were used to describe,classify and count adverse events.The reported odds ratio(ROR)and the medicines and he althcare products regulatory agency(MHRA)in the ratio imbalance measurement me thod were used to mine the data of ADE of plerixafor.RESULTS 488 ADE reports of plerixafor were retrieved,which involved 26 kinds of SOC,inc luding 595 reports belonged to serious ADE.The reporting personnel are mainly h ealthcare professional(43.65%).The ADE mainly occurred in USA(58.40%),A to tal of 69 ADE risk signals were obtained by ROR and MHRA,including many new adv erse reactions such as nictophobia,free haemoglobin present,urine bilirubin in creased.CONCLUSION During clinical dosing of plerixafor,shoul d be paid attention to the risks of nictophobia,infection,and urine bilirubin increased to insure the safety of drug in clinic.

关 键 词：普乐沙福 FAERS 药品不良事件 暗夜恐怖 

分 类 号：R969.3[医药卫生—药理学]