中国药物警戒2024,Vol.21Issue(3) :341-345.DOI:10.19803/j.1672-8629.20230531

基于FAERS数据库的秋水仙碱相关神经毒性风险分析

Risk assessment of colchicine-associated neurological adverse events based on FAERS database

吴汀溪 赵志刚 石延枫 张杨 张伊楠 朱斌
中国药物警戒2024,Vol.21Issue(3) :341-345.DOI:10.19803/j.1672-8629.20230531

基于FAERS数据库的秋水仙碱相关神经毒性风险分析

Risk assessment of colchicine-associated neurological adverse events based on FAERS database

吴汀溪 1赵志刚 1石延枫 2张杨 3张伊楠 1朱斌1
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作者信息

  • 1. 首都医科大学附属北京天坛医院药学部,北京 100070
  • 2. 首都医科大学附属北京天坛医院,国家神经系统疾病临床医学研究中心卒中多组学创新中心,北京 100070
  • 3. 首都医科大学附属北京友谊医院药学部,北京 100050
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摘要

目的 评价秋水仙碱相关神经系统不良事件(nAEs)的风险及特征,为临床用药安全提供参考.方法 基于美国食品药品监督管理局(FDA)不良事件报告系统(FAERS),检索2004 年1月1日至 2022年12月31日的秋水仙碱相关nAEs报告,采用比例失衡法和贝叶斯分析法对nAEs及缺血性、出血性中枢神经系统血管疾病不良事件进行信号挖掘,并分析事件发生时间及患者结局.结果 共提取秋水仙碱相关nAEs 906 例,报告例数排名前 3 位的不良事件分别是头痛(ROR025=1.09,IC025=0.30)、感觉减退(ROR025=1.79,IC025=1.09)、意识丧失(ROR025=1.62,IC025=0.99),在缺血性和出血性中枢神经血管疾病中均不存在信号.秋水仙碱相关nAEs发生时间中位数为30 d,7.42%的患者死亡.结论 秋水仙碱在缺血性和出血性中枢神经血管疾病中未检测到信号,但临床应警惕一些其他罕见神经毒性不良事件,加强监测.

Abstract

Objective To evaluate the neurological adverse events(nAEs)caused by colchicine and provide evidence for safe use of colchicine in stroke.Methods The nAEs related to colchicine that occurred between 2004 and 2022 were retrieved from the FDA Adverse Event Reporting System(FAERS)database to mine the signals via disproportionality analysis and Bayesian analysis.Results A total of 906 cases of colchicine-associated nAEs were collected,and the top three nAEs were headache(ROR025=1.09,IC025=0.30),and hypoaesthesia(ROR025=1.79,IC025=1.09),and loss of consciousness(ROR025=1.62,IC025=0.99).Overall,no signal was detected in the ischaemic and haemorrhagic disorders of the central nervous system.The median onset-time of colchicine-associated nAEs was 30d while the fatality rate was 7.42%.Conclusion Although no association is found between colchicine and ischaemic and haemorrhagic disorders of the central nervous system,more attention should be paid to some other rare neurological AEs during clinical practice.

关键词

秋水仙碱/中枢神经系统/神经毒性/缺血性/出血性/美国食品药品监督管理局不良事件报告系统/不良事件/信号挖掘

Key words

colchicine/central nervous system/neurotoxic/ischemic/hemorrhagic/FDA Adverse Event Reporting System(FAERS)/adverse event/data mining

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基金项目

北京市医院管理局临床医学发展专项扬帆计划(ZYLX201827)

中国毒理学会临床毒理专项(CST2021CT205)

出版年

2024
中国药物警戒
国家药品监督管理局药品评价中心(国家药品不良反应监测中心)

中国药物警戒

CSTPCD
影响因子:1.105
ISSN:1672-8629
参考文献量28
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