基于FAERS数据库对布洛芬与对乙酰氨基酚的安全性分析  

Safety Analysis of Ibuprofen and Acetaminophen Based on FAERS Database

作　　者：季泽俊[1] 付中华[2] 王俊霞[1] 聂建军[1] JI Ze-jun;FU Zhong-hua;WANG Jun-xia;NIE Jian-jun(Department of Clinical Pharmacy,the First Affiliated Hospital of Nanyang Medical College,Nanyang 473058,China;Department of Pharmacy,Henan Provincial People's Hospital,Zhengzhou 450003,China)

机构地区：[1]南阳医学高等专科学校第一附属医院临床药学部,南阳473058 [2]河南省人民医院药学部,郑州450003

出　　处：《中国合理用药探索》2023年第12期113-120,共8页Chinese Journal of Rational Drug Use

摘　　要：目的:利用美国食品药品监督管理局不良事件报告系统(FAERS)数据库分析布洛芬、对乙酰氨基酚单用或联用的药品不良事件(ADE)信号,为临床安全用药提供参考。方法:采用报告比值比(ROR)法对FAERS数据库收录的布洛芬、对乙酰氨基酚ADE报告进行信号挖掘,并借用监管活动医学词典(MedDRA)24.0版对信号的系统器官分类(SOC)和优选术语(PT)进行标准化编码,比较两药单用及联用的ROR值(95%CI下限)。结果:共检索到布洛芬、对乙酰氨基酚、两药联用(同时或交替)ADE报告数分别为158136、422566份和59556份,ADE中位时间分别为4(1,8)天、4(2,9)天和5(2,9)天,且ADE报告中女性占比均高于男性。两药联用的ROR值(95%CI下限)均大于两药单用的ADE共36件(50.70%);两药联用ROR值(95%CI下限)均小于两药单用的ADE共23件(32.39%),比值为1.57。两药联用会增加儿童发热、呕吐、脱水的发生风险。结论:布洛芬、对乙酰氨基酚单用或联用具有相近的ADE,但相关性强度有所差别,应尽量避免联用布洛芬、对乙酰氨基酚退热,尤其是在儿童群体中。在临床实践中应加强个体化用药,保障用药安全。Objective:To analyze the adverse drug event(ADE)signals of ibuprofen and acetaminophen alone or in combination using database of Food and Drug Administration Adverse Event Reporting System(FAERS)so as to provide reference for safe drug use in clinic.Methods:The signal mining of the ADE reports of ibuprofen and acetaminophen in FAERS database was conducted by reporting odds ratio(ROR)method,the system organ class(SOC)and preferred term(PT)of the signals were coded by Medical Dictionary for Regulatory Activities(MedDRA)version 24.0,and the ROR(lower limit of 95%CI)of the two drugs alone and in combination were compared.Results:A total of 158136,422566 and 59556 ADE reports were retrieved for ibuprofen,acetaminophen and their combination(used simultaneously or alternately),respectively,with the median ADE time of 4(1,8)days,4(2,9)days and 5(2,9)days,respectively,and more ADE reports in females than males.There were 36 ADEs with higher ROR(lower limit of 95%CI)with the combination therapy as compared with the monotherapy,accounting for 50.70%,and 23 ADEs with lower ROR(lower limit of 95%CI)with the combination therapy as compared with the monotherapy,accounting for 32.39%,with a ratio of 1.57.The combination of the two drugs was associated with additional risks of fever,emesis and dehydration in children.Conclusion:Ibuprofen and acetaminophen alone or in combination have similar ADEs but different strength of association,and combining ibuprofen and acetaminophen to reduce fever should be avoided whenever possible especially in pediatric population.Hence,it is necessary to strengthen personalized medication in clinical practice to ensure medication safety.

关 键 词：布洛芬 对乙酰氨基酚 美国食品药品监督管理局不良事件报告系统 不良事件 安全性 

分 类 号：R969.3[医药卫生—药理学]