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使用韩国不良事件报告系统 (KAERS) 数据库进行现实数据挖掘,用于检测抗精神病药物相关不良事件的信号

Suhyeon Moon¹, Minjung Ko¹, Yeo-Jin Choi²

¹Department of Biohealth Regulatory Science, Graduate School, Ajou University, Suwon 16499, Republic of Korea.

Medicina (Kaunas, Lithuania)

|October 26, 2024

概括

第二代抗精神病药物 (SGA) 可能导致运动障碍,挑战传统的FGA/SGA副作用分类. 这项研究发现,SGA与额外金字塔症状和代谢问题有关,而氨酸也显示了心血管信号.

科学领域:

药物监督药物监督药物监督
神经科学是一个神经科学.
心脏病学心脏病学

背景情况:

根据副作用概况 (EPS与心脏代谢) 将抗精神病药物分为FGA和SGA的传统分类是一种过度简化.
SGAs具有D2受体对抗性,表明可能出现额外金字塔症状 (EPSs).

研究的目的:

通过使用韩国不良事件报告系统 (KAERS) 数据库,调查FGA和SGA的药物不良事件 (ADE) 信号.
分析FGA和SGA之间的ADE分布,挑战二进制分类.

主要方法:

在2013年1月至2022年12月的KAERS数据上使用了不成比例分析 (PRR,ROR,IC).
在数据清理和复制后,分析了5249份相关的ADE报告.

主要成果:

阿里皮普拉 (SGA) 显示出对运动障碍的显著信号,包括EPS,震和阿卡西西亚.
奎蒂亚平 (SGA) 显示出心血管效应的信号,如血压升高和心动节律失常,以及外周.
代谢异常 (体重增加,食欲增加) 与四种SGA有关:阿里皮普拉,奥兰扎平,奎蒂亚平和RISPERIDONE.
对于FGA,没有检测到运动障碍信号,可能是由于报告数据有限.

结论:

药物不良事件在FGA和SGA之间的分布不是严格的二进制.
阿里皮普拉 (aripiprazole) 是一种SGA,与额外金字塔运动障碍有关.
四种SGA (aripiprazole, olanzapine,quetiapine,risperidone) 与代谢副作用有关,而quetiapine与心血管信号有关.

关键词:

卡尔斯数据库是卡尔斯的数据库.药物不良事件是药物不良事件.抗精神病药物抗精神病药物不成比例性分析分析药物诱导的运动障碍药物监督和药物监督现实世界的数据数据.信号检测分析信号检测分析

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