基于FAERS数据库的依达拉奉不良事件信号挖掘

Edaravone Adverse Event Signal Mining Based on FAERS Database

目的:挖掘美国食品药品监督管理局不良事件报告系统(FDA Adeverse Event Reporting System,FAERS)数据库中依达拉奉不良事件的相关临床报告,分析其在临床治疗中的安全性和有效性,为依达拉奉在临床中的应用提供参考。方法:从FAERS数据库中收集2017年4月—2022年12月有关依达拉奉不良事件的相关临床报告,并采用报告比值比(reporting odds ratio,ROR)法以及国际上常用ADE信号检测比例报告(proportional reportingratio,PRR)对数据进行分析。结果:共收集4367份报告,涉及全身性疾病及给药部位各种反应(43.46%)、各类神经系统疾病(13.28%)以及呼吸系统、胸及纵隔疾病(6.69%)等13类系统/器官分类项。其中,药物无效、患者疾病进展以及病情恶化的预警报告分别为239份、227份和125份,肌萎缩侧索硬化信号强度较高(PRR=1269.58),这些不良事件均未出现在说明书中。结论:依达拉奉相关报告反映出其在临床治疗中存在药效不理想的情况。因此,在依达拉奉的临床应用中,除了密切关注患者可能出现说明书包含的不良事件之外,还需根据患者实际情况采用联合用药的策略,保证临床干预的有效性。

OBJECTIVE To provide reference for clinical application of edaravone via excavating relevant clinical reports of adverse events in FAERS database of American and analyze the safety and effectiveness of edaravone in clinical treatment.METHODS Clinical reports of adverse events related to Edaravone from April 2017 to December 2022 were collected from the FAERS database,and the data were analyzed using the Reporting Odds Ratio(ROR)method and the proportional Reporting Gratio(PRR)report commonly used internationally.RESULTS 4367 reports were collected,covering 13 categories of system/organ classification items,including systemic diseases and various reactions at the administration site(43.46%),various neurological diseases(13.28%),and respiratory,thoracic,and mediastinal diseases(6.69%).Among them,report numbers of drug ineffectiveness,disease progression,and worsening of the condition were 239,227,and 125,respectively.The signal intensity of amyotrophic lateral sclerosis was high(PRR=1269.58),and all of these adverse events were appeared in the instruction manual.CONCLUSION The relevant reports indicate that edaravone may have low efficacy in clinical treatment.Therefore,in the clinical application of edaravone,in addition to closely monitor the adverse events that may occur in the patient’s manual,it is also necessary to adopt combination medication strategies based on the actual situation of the patient to ensure the effectiveness of clinical intervention.