基于美国食品药品监督管理局不良事件报告系统数据库的他克莫司致药品不良反应信号挖掘与分析  

Mining and Analysis of Adverse Drug Reaction Signals Caused by Tacrolimus Based on the U.S.Food and Drug Administration Adverse Event Reporting System Database

作　　者：程艺 陈晨 余春飞[3] 陈乾[5] 陈力[1,2] CHENG Yi;CHEN Chen;YU Chunfei;CHEN Qian;CHEN Li(Dept. of Pharmacy, West China Second Hospital of Sichuan University,Sichuan Chengdu 610041, China;Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education,Sichuan Chengdu 610041, China;Dept. of Pharmacy, Children's Hospital of Chongqing Medical University/Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing 400014, China;West China School of Pharmacy, Sichuan University,Sichuan Chengdu 610041, China;Dept. of Pharmacy, the First People's Hospital of Yibin, Sichuan Yibin, 644000, China)

机构地区：[1]四川大学华西第二医院药学部/循证药学中心,四川成都610041 [2]出生缺陷与相关妇儿疾病教育部重点实验室,四川成都610041 [3]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,重庆400014 [4]四川大学华西药学院,四川成都610041 [5]宜宾市第一人民医院药学部,四川宜宾644000

出　　处：《中国医院用药评价与分析》2020年第5期620-624,共5页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：四川省科技厅项目(No.2019JDR0163)。

摘　　要：目的:利用美国食品药品监督管理局(food and drug administration,FDA)不良事件报告系统(FDA adverse event reporting system,FAERS),挖掘与分析免疫抑制剂他克莫司致药品不良反应信号,为临床安全用药提供参考。方法:采用回顾性研究方法,利用报告比值比(reporting odds ratio,ROR)法和比例报告比值(proportional reporting ratio,PRR)法,对FEARS数据库中2009年第1季度至2019年第1季度共41个季度的他克莫司致不良事件报告进行数据挖掘与分析。结果:使用ROR法得到他克莫司致药品不良反应信号共1365个,将其信号强度按照降序排列得到排序居前50位的信号,其中原研药说明书中未提及的不良反应共14个,按世界卫生组织术语集分类累及2个新的系统;新的不良反应主要集中在泌尿系统损害、全身性损害、免疫功能紊乱、呼吸系统损害、代谢和营养障碍以及中枢和外周神经系统损害。结论:他克莫司药品说明书未收录的不良反应较多且累及器官和(或)系统分布广泛,建议临床用药时需谨慎。OBJECTIVE:To mine and analyze the adverse drug reaction signals caused by the immunosuppressive agent tacrolimus according to the U.S.Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database,so as to provide references for the application safety of drug use in clinic.METHODS:The method of retrospective analysis method,reporting odds ratio(ROR)method and proportional report ratio(PRR)method,data mining and analysis were conducted on tacrolimus-induced adverse event reports of 41 quarters from the 1st quarter of 2009 to the 1st quarter of 2019 in the FEARS database.RESULTS:A total of 1365 adverse drug reaction signals caused by tacrolimus were obtained by using ROR method.The signal strength was ranked in descending order to obtain the top 50 signals,among which there were 14 adverse drug reactions not mentioned in the original drug specification,and 2 new systems were involved according to the World Health Organization Terminology Set.New adverse drug reactions mainly focused on urinary system damage,systemic damage,immune dysfunction,respiratory system damage,metabolic and nutritional disorders,and central and peripheral nervous system damage.CONCLUSIONS:There are many adverse drug reactions with wide range of organs and/or systems involved that are not included in the instructions of tacrolimus.It is recommended to be cautious in clinical administration.

关 键 词：他克莫司 不良反应信号 比例失衡法 

分 类 号：R979.5[医药卫生—药品]