基于FAERS数据库的依达拉奉不良反应信号挖掘与分析

Mining and Analysis of Edaravone Adverse Reaction Signals Based on FAERS Database

目的:基于美国食品药品监督管理局不良事件报告系统(FDA Adverse Event Reporting System,FAERS)对依达拉奉引起的可疑药物不良事件(AE)进行信号挖掘分析,为临床使用依达拉奉治疗提供安全用药参考。方法:选取FAERS数据库中2004年第1季度至2023年第4季度上报的首要怀疑药物为依达拉奉的AE数据,采用报告比值比(ROR)法以及英国药品和医疗保健产品管理局(MHRA)的综合标准法进行信号监测与数据挖掘,对照《监管活动医学词典》中药物不良反应术语集的系统器官分类(SOC)和首选术语(PT)对AE报告进行分类和描述。结果:纳入研究报告共2910份,其中消费者主动上报占60.03%,79.66%的报告者来自于美国,经算法计算后挖掘出95个有效信号,包括死亡、疲劳、乏力等;涵盖全身性疾病在内的17个SOC;本研究中依达拉奉较为常见或相关性较高的AE信号胱抑素C升高、插管部位血栓、呼吸机依赖等,还发现未列入药品说明书的新的潜在风险信号6个,包括失语、言语障碍、大脑梗死、精力增加、出血性脑梗死、出血性梗死。结论:通过对FAERS数据库依达拉奉不良反应的挖掘分析,提示在临床使用该药物时一定避免呼吸衰竭致死亡等严重不良反应的发生,同时也需要密切关注未提示于说明书中但可能存在的新潜在不良反应。

Objective:To analyze the signal mining of suspected adverse drug events(AE)caused by edaravone based on FDA Adverse Event Reporting System,and to provide a safe medication reference for clinical use of edaravone.Methods:The AE data of edaravone,the primary suspected drug reported in the FAERS database from the first quarter of 2004 to the fourth quarter of 2023,were selected.The signal monitoring and data mining were carried out by using the reporting odds ratio(ROR)method and the comprehensive standard method of the British Medicine and Healthcare Products Administration(MHRA).The AE reports were classified and described by comparing the system organ classification(SOC)and preferred term(PT)of the adverse drug reaction terminology set in the Medical Dictionary of Regulatory Activities.Results:A total of 2910 research reports were included,of which 60.03% were actively reported by consumers,and 79.66% of the reporters were from the United States.After algorithm calculation,95 effective signals were mined,including death,fatigue and fatigue.17 SOCs including systemic diseases;in this study,the AE signals of edaravone were more common or highly correlated,such as elevated cystatin C,thrombosis at the intubation site,ventilator dependence,etc.,and 6 new potential risk signals that were not included in the drug instructions were also found,including aphasia,speech disorder,cerebral infarction,increased energy,hemorrhagic cerebral infarction,hemorrhagic infarction.Conclusion:Through the analysis of the adverse reactions of edaravone in the FAERS database,it is suggested that the occurrence of serious adverse reactions such as respiratory failure and death should be avoided in the clinical use of the drug.At the same time,it is also necessary to pay close attention to the new potential adverse reactions that may not be indicated in the instructions.