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基于真实世界数据的长春新碱不良事件信号挖掘与分析

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目的:挖掘真实世界中长春新碱潜在药物不良事件信号,为长春新碱的临床用药提供参考依据.方法:提取美国食品药品监管局不良事件报告系统(FAERS)自2004年1月1日-2024年3月31日的长春新碱药品不良事件(ADE),采用报告比值比(ROR)法和比例报告比值比(PRR)法进行信号挖掘,分析ADE发生情况.结果:在数据库中,以长春新碱为怀疑对象的ADE报告共3911份,识别出317个ADE信号,共涉及22个系统器官,挖掘到204个新的疑似不良反应,信号分布较多的SOC包括:血液及淋巴系统疾病、各类神经系统疾病、感染及侵染类疾病.结论:长春新碱在真实世界中发生的常见不良反应与说明书大体一致,但临床使用时应特别关注新的不良反应,药品上市许可持有人应及时修订说明书,关注药品安全.
Signal Mining and Analysis of Vincristine Adverse Events Based on Real-world Data
Objective:To mine potential vincristine-related adverse drug events(ADE)signals based on real world data and to provide a reference for the safe clinical use of vincristine.Methods:The US Food and Drug Administration Adverse Event Reporting System(FAERS)was used to extract adverse events of vincristine from January 1,2004 to March 31 2024.The signal mining was performed using reporting odds ratio and proportional reporting ratio to analyze the occurrence of ADE.Results:In the database,a total of 3911 ADE reports were suspected of vincristine,and 317 ADE signals were identified,involving 22 sys-tem organs,and 204 new suspected adverse reactions were excavated.Conclusion:The common adverse reactions of vincristine in the real world are generally the same as the instructions,but special attention should be paid to the new adverse reactions in clinical use to conduct pharmaceutical monitoring and pro-mote rational drug use;Marketing Authorization Holders should revise the instructions timely and pay at-tention to drug safety.

VincristineAdverse drug eventsReal-world dataFAERSSignal mining

姚立娟、邓晓文、刘丽丽、季留连、成美、顾萍辰

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盐城市食品药品监督检验中心,盐城 224000

盐城市第二人民医院肿瘤科,盐城 224000

盐城市第一人民医院 药学部,盐城 224000

长春新碱 药物不良事件 真实世界数据 美国食品药品监管局不良事件报告系统 数据挖掘

2024

药学与临床研究
江苏省药学会

药学与临床研究

CSTPCD
影响因子:0.95
ISSN:1673-7806
年,卷(期):2024.32(6)