摘要
目的挖掘和分析奥拉帕利的不良事件(ADE)信号,为临床安全合理用药提供依据。方法应用比值失衡法中的报告比值比法(ROR)和综合标准法(MHRA)对美国FDA不良事件报告系统(FAERS)中奥拉帕利2018年第一季度至2020年第四季度的药品不良事件报告进行数据挖掘及分析。结果共收集到11368例ADE报告,得到信号162个,主要集中在全身性疾病及给药部位各种反应、血液及淋巴系统、胃肠系统等方面。未在说明书中提及、临床需关注的信号有:肠梗阻、腹水、间质性肺疾病等。结论对奥拉帕利ADE信号进行挖掘和分析,有助于积极采取相应措施,为临床安全用药提供参考。
Objective To mine the adverse drug event(ADE)signals of olaparib,so as to provide reference for clinical safe and rational drug use.Methods The ADE of olaparib received by the US FDA adverse event reporting system(FAERS)from the first quarter of 2018 to the fourth quarter of 2020 were collected,and were analyzed with the reporting odds ratio(ROR)method and the medicines and healthcare products regulatory agency(MHRA)method.Results A total of 11368 reports were collected,and 162 signals of olaparib were obtained with the methods.The signals mainly focused on systemic diseases and various reactions at the administration site,blood and lymphatic system,gastrointestinal system and so on.Signals that were not mentioned in the drug instructions but required clinical concern included ileus,ascites,interstitial lung disease and so on.Conclusion The ADE signals of olaparib mined and evaluated by ROR and MHRA methods can provide references for clinical rational use of olaparib.
作者
韩梦婷
黄佳
陈玲
伏箫燕
钟薇
陈力
HAN Mengting;HUANG Jia;CHEN Ling;FU Xiaoyan;ZHONG Wei;CHEN Li(Department of Pharmacy,Xindu District People’s Hospital,Chengdu,Sichuan,610500,China;Department of Pharmacy,Chengdu,Sichuan,610041,China;Evidence-based Pharmacy Center,Chengdu,Sichuan,610041,China;Education Ministry Key Laboratory of Birth Defects and Related Gynecological and Child-hood Diseases,Chengdu,Sichuan,610041,China)
出处
《肿瘤药学》
CAS
2021年第3期269-273,283,共6页
Anti-Tumor Pharmacy
基金
成都市医学科研课题(2020114)。
