摘要
Abstract
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 158 136,422 566 and 59 556 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Key words
ibuprofen/acetaminophen/FDA Adverse Event Reporting System/adverse events/safety分类
医药卫生
