莫达非尼不良事件风险信号的数据挖掘和分析  

Signal Data Mining and Analysis of Modafinil Related Adverse Events

作　　者：郝晓伟 欧阳山丹 文晓丽 林珍 范华强 张博[2] HAO Xiao-wei;OUYANG Shan-dan;WEN Xiao-li;LIN Zhen;FAN Hua-qiang;ZHANG Bo(Army 73rd Group Army Hospital of PLA,Xiamen 361001,China;Southern Meclical Branch of PLA General Hospital,Beijing 100072,China)

机构地区：[1]陆军第73集团军医院,福建厦门361001 [2]解放军总医院京南医疗区,北京100072

出　　处：《解放军药学学报》2024年第5期443-448,共6页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的对莫达非尼药品不良事件的发生状况和一般规律进行数据挖掘和分析,为莫达非尼的临床安全用药提供参考。方法从美国食品药品监督管理局药品不良事件报告系统(FAERS)调取2004年1月1日至2023年9月30日莫达非尼不良事件报告,采用报告比值比法(ROR)、比例报告比法(PRR)及英国药品和保健标准法挖掘数据,对患者的基本信息、风险信号等进行回顾性分析。结果共获得莫达非尼不良事件报告1933份(女性51.22%,男性35.02%),年龄以18~64岁为主,报告中以美国占比最高(73.10%),报告者主要为消费者(56.18%)。报告共涉及1163个信号,发生频次较高的是药物无效(381例)、疲劳(163例)、嗜睡(147例);检出阳性信号193个,其中报告数大于10例且与不良反应相关的阳性信号共43个,主要为精神病类(21个)和各类神经系统疾病(13个),信号强度排名前三位的是猝倒症(ROR=107.90,PRR=107.61)、嗜眠症(ROR=87.47,PRR=87.24)、睡眠过度(ROR=9.99,PRR=9.95),其中实施自杀行为、戒断综合征、自发流产等12项不良反应在说明书中未提及。结论FAERS有助于提高医务者对莫达非尼临床应用风险信号的认识;在莫达非尼的临床应用过程中,应重点关注药物滥用、自杀倾向、猝倒症、皮疹和心脏疾病等不良反应的发生。Objective To analyze the incidence and regularities of adverse drug events(ADEs)related to Modafinil,and to provide references for safe drug use in clinic.Methods The reports of ADEs of Modafinil collected between January 1,2004 and September 30,2023 were retrieved from the Adverse Event Reporting System(FAERS)of the Food and Drug Administration(FDA).The basic data of patients and risk signals were retrospectively analyzed using the reporting odds ratio(ROR)method,proportional reporting ratio(PRR)method and Medicines and Healthcare Products Regulatory Agency(MHRA)method.Results A total of 1933 ADE reports of Modafinil were obtained,involving more females(51.22%)than males(35.02%).Most of them were aged 18 to 64.The United States accounted for the highest proportion of reports(73.10%),and the majority of reporters were consumers(56.18%).A total of 1163 signals were reported.The top three frequent signals were drug ineffectiveness(381 cases),fatigue(163 cases),and somnolence(147 cases).A total of 193 positive signals were detected,43 of which involved more than 10 cases and were related to adverse reactions due to psychiatric disorders(21 signals)and nervous system disorders(13 signals).The top three conditions in terms of signal intensities were cataplexy(ROR=107.90,PRR=107.61),narcolepsy(ROR=87.47,PRR=87.24),and hypersomnia(ROR=9.99,PRR=9.95).Twelve items,such as suicidal attempt,withdrawal syndrome,and spontaneous abortion,were not mentioned in the instructions.Conclusion The FAERS can make health care providers better aware of the risk signals of Modafinil.During clinical use of Modafinil,attention should be paid to the adverse reactions such as drug abuse,suicidal tendency,cataplexy,rash and heart disease.

关 键 词：莫达非尼 药品不良事件 FDA不良事件报告系统 数据挖掘 

分 类 号：R969.3[医药卫生—药理学]