中国医院用药评价与分析2024，Vol.24Issue(11)：1389-1393,5.DOI:10.14009/j.issn.1672-2124.2024.11.021
基于美国FAERS数据库的头孢曲松钠相关药品不良事件信号挖掘与分析
Mining and Analysis of Adverse Drug Event Signals Induced by Ceftriaxone Sodium Based on the U.S.Food and Drug Administration Adverse Event Reporting System Database
摘要
Abstract
OBJECTIVE:To explore the adverse drug events(ADE)signals induced by ceftriaxone sodium,so as to provide reference for rational clinical drug use.METHODS:Open Vigil 2.1 online tool was used to extract ADE reports of ceftriaxone sodium from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database from 2004 to 2023,with the generic name"Ceftriaxone"and the brand name"Rocephin"as search criteria.ADE signal mining was conducted by using the Bayesian confidence propagation neural network(BCPNN)methods and reporting odds ratio(ROR).The international medical dictionary for regulatory activities(MedDRA)version 26.1 was used for system organ class(SOC)classification.RESULTS:A total of 6 180 ADE reports(6 180 patients)with ceftriaxone sodium as the primary suspected drug were extracted.The proportion of males(2 655 cases,42.96%)was slightly lower than that of females(2 789 cases,45.13%).Among the aforementioned ADE,the majority occurred in patients aged from 18 to 65 years(2 186 cases,35.37%).Reports of severe ADE accounted for 58.54%(3 618 cases),with the highest number related to hospitalization or prolonged length of stay(2 147 cases,34.74%).A total of 429 ADE signals were detected,involving 10 898 related reports and 25 SOC,including immune system diseases,skin and subcutaneous tissue diseases,hepato-biliary disorders.According to the information component(IC)value and ROR,in the top 30 ADE,in addition to hemolytic anemia,eosinophilia,acute generalized exanthematous pustulosis,and toxic encephalopathy in drug instructions,new ADE such as Ⅴ factor inhibition(ROR=258.45,IC=3.63),allergic coronary artery spasm syndrome(ROR=44.36,IC=4.01),Jarisch-Herxheimer reaction(ROR=328.97,IC=5.52),and choreoathetosis(ROR=129.55,IC=4.47)were detected.CONCLUSIONS:Caution should be exercised during the clinical use of ceftriaxone sodium due to the common ADE including pseudolithiasis,hemolytic anemia and allergy.Attention should also be given to monitoring ADE not mentioned in the drug instructions,such as Ⅴ factor inhibition,allergic coronary artery spasm syndrome,Jarisch-Herxheimer reaction,and choreoathetosis.关键词
头孢曲松钠/药品不良事件/美国食品药品监督管理局不良事件报告系统/信号挖掘Key words
Ceftriaxone sodium/Adverse drug events/U.S.Food and Drug Administration Adverse Event Reporting System/Signal mining分类
医药卫生引用本文复制引用
张坤,邓燕,欧阳冰,蔡永青,蒋婷婷,刘耀..基于美国FAERS数据库的头孢曲松钠相关药品不良事件信号挖掘与分析[J].中国医院用药评价与分析,2024,24(11):1389-1393,5.基金项目
重庆市临床药学重点专科建设项目(渝卫办发[2020]68 号) （渝卫办发[2020]68 号）
重庆市中青年医学高端人才项目 （）
