PDF(Pubmed)
Abstract：
(1) Background: The utilization of high-quality evidence regarding the safety of anti-seizure medications (ASMs) is constrained by the absence of standardized reporting. This study aims to examine the safety profile of ASMs using real-world data. (2) Methods: The data were collected from the Korea Adverse Event Reporting System Database (KAERS-DB) between 2012 and 2021. In total, 46,963 adverse drug reaction (ADR)-drug pairs were analyzed. (3) Results: At the system organ class level, the most frequently reported classes for sodium channel blockers (SCBs) were skin (37.9%), neurological (16.7%), and psychiatric disorders (9.7%). For non-SCBs, these were neurological (31.2%), gastrointestinal (22.0%), and psychiatric disorders (18.2%). The most common ADRs induced by SCBs were rash (17.8%), pruritus (8.2%), and dizziness (6.7%). Non-SCBs were associated with dizziness (23.7%), somnolence (13.0%), and nausea (6.3%). Rash, pruritus, and urticaria occurred, on average, two days later with SCBs compared to non-SCBs. Sexual/reproductive disorders were reported at a frequency of 0.23%. SCBs were reported as the cause more frequently than non-SCBs (59.8% vs. 40.2%, Fisher\'s exact test, p < 0.0001). (4) Conclusions: Based on real-world data, the safety profiles of ASMs were identified. The ADRs induced by SCBs exhibited different patterns when compared to those induced by non-SCBs.
摘要：
（1）背景：关于抗癫痫药物（ASM）安全性的高质量证据的利用受到缺乏标准化报告的限制。本研究旨在使用真实世界数据检查ASM的安全性。（2）方法：数据收集自2012年至2021年的韩国不良事件报告系统数据库（KAERS-DB）。总的来说,分析46,963例药物不良反应(ADR)-药物对。（3）结果：在系统器官类别级别，最常见的钠通道阻滞剂（SCB）类别是皮肤（37.9％），神经学（16.7%），和精神病(9.7%)。对于非SCB，这些是神经学的(31.2%)，胃肠道（22.0%），和精神疾病(18.2%)。SCBs最常见的不良反应是皮疹（17.8%），瘙痒（8.2%），和头晕(6.7%)。非SCB与头晕有关（23.7%），嗜睡（13.0%），恶心(6.3%)。皮疹,瘙痒,出现荨麻疹,平均而言,两天后，SCB与非SCB进行了比较。性/生殖障碍的报告频率为0.23%。SCB被报告为病因的频率高于非SCB(59.8%vs.40.2%,费希尔的精确检验，p<0.0001)。(4)结论：基于现实世界的数据，ASM的安全性被确定.与非SCB诱导的ADR相比，SCB诱导的ADR表现出不同的模式。
