Solriamfetol上市后真实世界不良反应研究

Adverse reactions of solriamfetol after listing based on real world data

目的利用美国食品药品监督管理局药物不良事件报告系统(FAERS)检索solriamfetol上市后的不良反应报告,挖掘和分析该药的不良反应,以期为临床合理用药提供参考。方法检索FAERS系统中2019年1月1日至2020年3月31日的solriamfetol不良反应报告数据,使用MYSQL软件对数据进行整理分析。结果以solriamfetol为首要怀疑药品的不良反应报告122份,其中严重药品不良反应14份。累及系统-器官分类主要为:精神疾病、神经系统疾病、心脏疾病、呼吸道、胸部和纵隔腔疾病等,不良反应类型发生频率前10位为焦虑/紧张不安、失眠、感觉异常、胸痛、心动过速、自杀意念/自我伤害、干扰注意力、头晕、头痛、乏力。已知的报告者以消费者为主,发生不良反应的患者主要为女性,平均年龄为(31.95±15.26)岁,主要集中于18~45岁之间,适应证主要为嗜睡症,剂量以150 mg·d^(-1)为多,83.33%的患者用药时间<1个月即出现不良反应。结论Solriamfetol在临床应用过程中应加予关注,严格把握用药指征,做好用药宣教,加强用药监护,注意用药安全。

Objective To analyze ADR induced by solriamfetol after listing via the FAERS(the US Food and Drug Administration Adverse Event Reporting System)so as to provide reference for clinical rational drug use.Methods The data on adverse reaction reports of solriamfetol submitted to the FAERS between January 1,2019 and March 31,2020 was retrieved and analyzed by MYSQL software.Results There were 122 ADR reports with solriamfetol as the primary suspected drug,14 of which involved severe ADR.The main symptoms were psychiatric disorders,nervous system disorders,cardiac disorders,respiratory disorders,thoracic and mediastinal disorders.The top ten types of adverse reactions were anxiety,insomnia,paraesthesia,chest pain,sinus tachycardia,suicidal ideation,disturbance in attention,dizziness,headache and fatigue.Most of the people who reported discomfort were consumers,and the most of the patients with adverse reactions were female,with an average age of(31.95±15.26)years.Narcolepsy was the main manifestation,and the dose of 150 mg·d^(-1) was the most common.83.33%of the patients developed adverse reactions after less than one month of medication.Conclusion The analysis of the incidence of adverse reactions after the listing of solriamfetol by means suggests that we should pay more attention to this drug in the process of clinical application,keep in mind the indications of drug use and try every means available to ensure the safety of this drug.