基于FAERS数据库的福沙匹坦不良事件信号挖掘  

Data-Mining of Adverse Events Signals for Fosaprepitant Based on FAERS Database

作　　者：刘迅[1,2] 陈力 陈乾[4] 肖潇[1] 余瑛[2] LIU Xun;CHEN Li;CHEN Qian;XIAO Xiao;YU Ying(Chengdu Seventh People's Hospital,Chengdu,Sichuan,China 610041;College of Pharmacy and Biological Engineering,Chongqing University of Technology,Chongqing,China 400054;West China Second University Hospital,Sichuan University,Chengdu,Sichuan,China 610041;The First People's Hospital of Yibin City,Yibin,Sichuan,China 644000)

机构地区：[1]四川省成都市第七人民医院,四川成都610041 [2]重庆理工大学药学与生物工程学院,重庆400054 [3]四川大学华西第二医院,四川成都610041 [4]四川省宜宾市第一人民医院,四川宜宾644000

出　　处：《中国药业》2023年第11期102-107,共6页China Pharmaceuticals

基　　金：四川省科技计划项目[2019JDR0163]。

摘　　要：目的促进福沙匹坦的临床安全、合理应用。方法采用比例失衡法中报告比值比(ROR)法、比例报告比(PRR)法和综合标准(MCA)法分析福沙匹坦可疑的药品不良事件(ADE)信号,对美国食品和药物管理局不良事件报告系统(FAERS)中2016年第一季度至2021年第二季度共22个季度的福沙匹坦相关ADE报告进行数据挖掘。结果提取以福沙匹坦为首要怀疑药物的ADE报告584份,首选语共1992个,涉及548例患者。其中,男女比例约为1∶1;年龄主要集中于50~<70岁,占48.54%;医师、药师、消费者为主要上报人群,分别占65.15%,14.42%,10.40%。共得到ADE信号88个,其中药品说明书未提及的有71个,发生频次最高的ADE为恶心、发热、呼吸困难,相关性(信号强度)较高的ADE为反射性食管炎、呃逆、静脉炎;涉及17个系统/器官,主要集中在胃肠系统疾病、血液及淋巴系统疾病、全身性疾病及给药部位各种反应与呼吸系统、胸及纵隔疾病,分别占22.86%,15.67%,13.61%,13.30%。结论临床应用福沙匹坦时应高度关注药物间可能的相互作用、原发疾病及复杂的合并用药,密切监测ADE发生,提高风险获益水平。Objective To promote the clinical safety and rational use of fosaprepitant.Methods The reporting odds ratio(ROR),proportional reporting ratio(PRR),and multicriteria analysis(MCA)methods in the proportional imbalance method were used to analyze the suspicious adverse drug event(ADE)signals of fosaprepitant.Data-mining was conducted on the ADE reports related to fosaprepitant from the first quarter of 2016 to the second quarter of 2021(a total of 22 quarters)in the FDA Adverse Event Reporting System(FAERS).Results A total of 548 ADE reports(1992 preferred terms)were reported in which fosaprepitant was extracted as the primary suspected drug,involving 548 patients.Among them,the male-to-female ratio was about 1∶1 and mainly concentrated in patients'age of≥50 years old and<70 years old,accounting for 48.54%.Physicians,pharmacists,and consumers were the main reporting groups,accounting for 65.15%,14.42%,and 10.40%,respectively.A total of 88 ADE signals were obtained,of which 71 signals were not mentioned in the package insert of drugs.The ADEs with the highest frequency of occurrence were nausea,fever,and difficulty breathing.The ADEs with high correlation(signal intensity)were reflex esophagitis,hiccup,and phlebitis.The ADEs involved 17 systemic organs,mainly concentrated in gastrointestinal system diseases,blood and lymphatic system diseases,systemic diseases,various reactions at the administration site,respiratory system,chest and mediastinal diseases,accounting for 22.86%,15.67%,13.61%,and 13.30%,respectively.Conclusion When fosaprepitant is used in the clinic,high attention should be paid to possible drug-drug interactions,primary diseases,and complex comorbidities,and close monitoring of patients'ADE occurrence should be carried out to improve the risk-benefit level.

关 键 词：福沙匹坦 药品不良事件 信号挖掘 美国食品和药物管理局不良事件报告系统 比例失衡法 

分 类 号：R95[医药卫生—药学] R975.4