中国药房2024，Vol.35Issue(2)：210-213,4.DOI:10.6039/j.issn.1001-0408.2024.02.15
塞利尼索不良事件信号挖掘与分析
Signal mining and analysis of selinexor adverse events
摘要
Abstract
OBJECTIVE To mine the adverse drug event(ADE)signals of selinexor,and to provide reference for its clinical safety medication.METHODS ADE data for selinexor reported from July 3rd,2019 to March 31st,2023 were collected from the FDA adverse event reporting system(FAERS).Data mining was performed by using the reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods,and categorization statistics were performed by using the system organ class(SOC)and preferred term(PT)from drug ADE terminology set in the MedDRA(version 26.0).RESULTS A total of 3 084 ADE reports were obtained for selinexor,with a total of 134 ADE-positive signals.Among the reported genders,there were 127 males and 124 females,with a predominant age of≥65 years old(4.12%);the United States had the highest number of reports(96.53%),with consumers being the main reporters(77.27%);severe ADR was mainly characterized by hospitalization/prolonged hospitalization(26.26%),followed by death(17.15%).The top 3 ADE in the list of frequency were nausea(1 162 times),fatigue(790 times)and anorexia(610 times),all of which were mentioned in the selinexor's instructions.The top 3 signals in the list of strength were device-associated bacteremia(ROR=115.07,PRR=114.94),blepharospasm dysfunction(ROR=106.70,PRR=106.54),and salmonella sepsis(ROR=99.90,PRR=99.81),all of which were not mentioned in the selinexor's instructions.CONCLUSIONS In addition to the ADE of nausea mentioned in the instruction manual,attention should also paid to device-associated bacteremia,blepharospasm dysfunction,salmonella sepsis,and other ADE not mentioned in the instruction manual when using selinexor in clinical practice;weekly rechecking of the patient's blood routine should be done to monitor the patient's blood indexes,symptoms of infection,and so on,to ensure that the safety of drug use.关键词
塞利尼索/药品不良事件/信号挖掘/FDA不良事件报告系统Key words
selinexor/adverse drug event/signal mining/FDA adverse event reporting system分类
医药卫生引用本文复制引用
陈亚轻,徐梦丹,顾航烨,吴君琳,陈永..塞利尼索不良事件信号挖掘与分析[J].中国药房,2024,35(2):210-213,4.基金项目
中央财政医疗服务与保障能力提升资金项目(No.粵财社[2021]199号) （No.粵财社[2021]199号）
广东省医疗服务与保障能力提升项目(国家临床重点专科建设项目)(No.粵卫医函[2021]206号) （国家临床重点专科建设项目）
广东省药品监督管理局科技创新项目(No.2022ZDZ06) （No.2022ZDZ06）
