摘要
目的利用美国FDA不良事件报告系统(FAERS)的数据挖掘头孢他啶阿维巴坦(CZA)的药物不良事件(ADE)信号,为临床安全用药提供参考。方法利用报告比值比(ROR)法、综合标准(MHRA)法对美国FAERS中2015年第2季度至2020年第4季度收到的CZA为首要怀疑药物的不良事件报告进行数据挖掘。结果设定时段内FAERS共收到以CZA为首要怀疑药物的ADE报告1045例,ROR法和MHRA法获得的风险信号完全重叠,共获得CZA不良事件信号44个,将其信号强度按照降序排列,病原体耐药的ADE信号最强,有31个不良事件信号未在CZA药品说明书中出现,感染及侵染类疾病、神经系统疾病、肾脏及泌尿系统疾病、肝胆系统疾病、各种检查是报告例数最多的几个系统。结论挖掘和评价基于美国FAERS数据库获得的CZA不良事件相关信号,可为其临床安全用药供依据。
AIM To mine the adverse drug event(ADE)signal of ceftazidime/avibactam(CZA)by the FDA adverse event reporting system(FAERS),so as to provide reference for clinical safe drug use.METHODS Data mining was conducted for adverse event reports of primary suspected drugs of CZA received from FAERS data from the second quarter of 2015 to the fourth quarter of 2020 by using the reported odds ratio method(ROR)and medicines and healthcare products regulatory agency method(MHRA).RESULTS In the set period,FAERS received a total of 1045 ADE reports with CZA as the primary suspected drug.The risk signals obtained by ROR method and MHRA method were completely overlapped,and a total of 44 CZA adverse event signals were obtained.The signal intensity was arranged in descending order,and the ADE signals of pathogen resistance were the strongest.Totally 31 adverse event signals did not appear in the CZA drug instructions.Infection and infection diseases,nervous system diseases,kidney and urinary system diseases,hepatobiliary system diseases and various examinations were the most reported systems.CONCLUSION Data mining and evaluation of CZA adverse event signals based on FAERS database can provide evidence for clinical safe use of CZA.
作者
芦小燕
陈维
戴幼琴
盛洁
LU Xiaoyan;CHEN Wei;DAI Youqin;SHENG Jie(Department of Pharmacy,HwaMei Hospital,University of Chinese Academy of Sciences,Ningbo 315010,China;College of Pharmaceutical Engineering,Zhejiang Pharmaceutical University,Ningbo 315100,China)
出处
《中国临床药学杂志》
CAS
2022年第9期641-646,共6页
Chinese Journal of Clinical Pharmacy
基金
2020年浙江省医学会临床科研基金项目(第二批)(编号2020ZYC-B30)
中国科学院大学宁波华美医院“华美研究基金”(编号2021HMKY15)
关键词
头孢他啶阿维巴坦
药物不良事件信号
数据挖掘
报告比值比法
综合标准法
ceftazidime/avibactam
adverse drug event signal
data mining
reported odds ratio method
medicines and healthcare products regulatory agency method
