基于FAERS的右美托咪定相关不良反应数据挖掘  

Data-Mining of Dexmedetomidine-Related Adverse Drug Reaction Based on FAERS

作　　者：裴昱文 基鹏[1] 周灵妍 吴斌[1,2] 何治尧 徐珽[1,2] PEI Yuwen;JI Peng;ZHOU Lingyan;WU Bin;HE Zhiyao;XU Ting(West China Hospital,Sichuan University,Chengdu,Sichuan,China 610041;West China School of Pharmacy,Sichuan University,Chengdu,Sichuan,China 610041)

机构地区：[1]四川大学华西医院,四川成都610041 [2]四川大学华西药学院,四川成都610041

出　　处：《中国药业》2021年第9期77-80,共4页China Pharmaceuticals

基　　金：国家自然科学基金[81602699]。

摘　　要：目的挖掘右美托咪定的药品不良反应(ADR)信号,为临床安全用药提供参考。方法收集美国食品药物管理局不良事件报告系统(FAERS)2004年第1季度至2018年第4季度(共60个季度)的美国信息交换标准代码(ACSⅡ)数据,采用MedexUIMA1.3.7系统对药品名称进行标准化处理,采用《ICH国际医学用语词典》(MedDRA 21.1)对REAC表中ADR名称进行系统映射和翻译,采用报告比值比(ROR)法和比例报告比值比(PRR)法进行ADR信号检测。分别对报告患者基本信息、报告者类型、时间和国家分布、信号检测结果、合并用药,以及特殊人群用药进行分析。结果共提取到ADR报告记录9289249条,其中以右美托咪定为首要怀疑药物的ADR报告患者852例,涉及ADR 1902例次;经ROR法检测出129个信号,经PRR法检测出126个信号。除"超说明书使用""感染性肺炎""高血压"3个信号外,ROR法与PRR法检测出的信号重合;2016年,右美托咪定ADR报告例数较2015年增长2倍,美国和日本对右美托咪定ADR的重视程度可能高于其他国家;医师和其他卫生专业人员占报告者的76.29%(650/852),药师占16.55%(141/852);患者中位年龄55岁,平均48岁,60岁以上的老年人占28.87%(246/852);发生频率排前50的ADR中,涉及最多的系统/器官分类为心脏器官疾病占24.32%(213/876),其中发生频率最高的为心动过缓,占32.86%(70/213);合并用药频率排前10的药物以麻醉药为主。结论右美托咪定静脉输注过程中,应密切监测患者的心率及血压;与七氟醚联用时,应密切关注患者的血压变化;老年患者应酌情减少剂量,以避免ADR发生。临床应用过程中应提高对右美托咪定安全性相关问题的关注。Objective To mine the dexmedetomidine-realated adverse drug reaction(ADR)signals,and to provide a reference for safe use of dexmedetomidine in the clinic.Methods The American Standard Code for Information Interchange(ACSⅡ)data files of 60 quarters(from the first quarter of 2004 to the fourth quarter of 2018)were downloaded from the FDA Adverse Event Reporting System(FAERS).MedexUIMA1.3.7 system was used to standardize the drug names,and MedDRA21.1 was used to systematically map and translate ADR names in the REAC table.The reporting odd ratio(ROR)method and proportional reporting ratio(PRR)algorithm were used to detect ADR signals.The basic information of reported patients,types of reporters,time distribution and country distribution,signal detection results,combined medication,and medication for special groups were analyzed.Results A total of 9289249 ADR reports were extracted,including 852 ADR reports with dexmedetomidine as the″primary suspect drug″,involving 1902 ADR cases.A total of129 signals were obtained through ROR method,and 126 signals were obtained through PRR method.Except for the three signals of″off label use″″infectious pneumonia″and″hypertension″,the signals obtained through ROR method coincided with those through PRR method.The reported cases of dexmedetomidine-related ADR in 2016 increased by 2 times compared with those in 2015.The United States and Japan might pay more attention to dexmedetomidine-related ADR than other countries.Among the ADR reporters,physicians and other health professionals accounted for 76.29%(650/852),and pharmacists accounted for 16.55%(141/852).The median age of the patients was 55 years old,and the average age was 48 years old,the elderly over 60 years old accounted for 28.87%(246/852).Among the top 50 ADRs of occurrence frequency,the most involved system organ class(SOC)was heart organ diseases,accounting for24.32%(213/876),among which the occurrence frequency of bradycardia was the highest,accounting for 32.86%(70/213).Anesthetics were the main dru

关 键 词：右美托咪定 不良反应信号 美国食品药物管理局不良事件报告系统 数据挖掘 

分 类 号：R969.3[医药卫生—药理学] R971.3[医药卫生—药学]