基于FAERS的阿片类药物不良事件性别差异的信号挖掘与分析  

Data Mining and Analysis of Safety Signals of Gender Differences in Opioids Adverse Events Based on FAERS

作　　者：季欢欢[1] 张妮[1] 霍本念 贾运涛[1] JI Huanhuan;ZHANG Ni;HUO Bennian;JIA Yuntao(Department of Pharmacy,Ministry of Education Key Laboratory of Child Development and Disorders,National Clinical Research Center for Child Health and Disorders,China International Science and Technology Cooperation base of Child Development and Critical Disorders,Chongqing Key Laboratory of Pediatrics,Children’s Hospital of Chongqing Medical University,Chongqing,400014,China)

机构地区：[1]重庆医科大学附属儿童医院药学部、儿童发育疾病研究教育部重点实验室、国家儿童健康与疾病临床医学研究中心、儿童发育重大疾病国家国际科技合作基地、儿科学重庆市重点实验室,重庆400014

出　　处：《医药导报》2023年第5期755-759,共5页Herald of Medicine

基　　金：重庆医科大学2021年校级研究生教育教学改革研究项目(xyjg210219);重庆市科卫联合医学科研青年项目(2023QNXM033);重庆市科卫联合医学科研重点项目(2022ZDXM020);重庆医科大学未来医学青年创新团队(W0081);重庆医科大学智慧医学研究项目(ZHYX202216)。

摘　　要：目的 挖掘和分析阿片类药物不良事件(ADE)性别差异的信号,为临床实施个体化用药提供参考。方法 调取美国食品药品管理局不良事件报告系统(FAERS)数据库2004年1月1日—2020年9月30日接收的吗啡和芬太尼ADE报告,采用报告比值比(ROR)数据挖掘方法进行信号挖掘,重点分析阿片类药物性别差异的信号强度。结果 纳入分析的吗啡ADE报告女性和男性分别为7968,7570份;芬太尼女性和男性报告为37 505,26 866份。经ROR挖掘,男性更易出现药物依赖性、戒断综合征、呼吸抑制、药物过量及滥用等,而女性更易出现药物不耐受、恶心、呕吐、抑郁、皮疹、瘙痒、关节痛等。结论 阿片类药物不良事件信号存在性别差异,临床实践中应充分利用以探索机会性治疗可能。Objective To mine and evaluate the safety warning signals of gender differences in opioids,and to provide references for clinic implementation of individualized drug use.Methods Reporting odd ratio(ROR)data mining algorithm was used to investigate signals of gender differences for morphine and fentanyl from the FDA adverse event reporting system from January 1,2004 to September 30,2020.Results The female and male reports of morphine included in the analysis were 7968 and 7570,respectively.And the female and male reports of fentanyl were 37505 and 26866,respectively.ROR mining showed that men were more likely to develop drug dependence,withdrawal syndrome,respiratory depression,drug overdose and abuse,while women are more likely to develop syndromes such as drug intolerance,nausea,vomiting,depression,rash,pruritus,and joint pain.Conclusion There are gender differences in the signals of adverse events of opioids,which should be fully utilized in clinical practice to explore the possibility of opportunistic treatment.

关 键 词：阿片类药物 性别差异 信号挖掘 药物不良事件 

分 类 号：R971[医药卫生—药品] R969.3[医药卫生—药学]