PDF(Pubmed)
Abstract：
OBJECTIVE: Currently, we have a shortage of comprehensive information about newer antiepileptic drugs (AEDs) in the pediatric population. This might explain the discrepancies among pediatricians\' preferences in this regard. Therefore, it is crucial to study the multifaceted impacts of these drugs on children. The endpoints of our study were non-AED predictors of the requirement of combination therapy for seizure management, seizure-free period >6 months and >12 months, change in Quality of Life in Childhood Epilepsy Questionnaire - 55 (QOLCE-55), and incidence of adverse events.
METHODS: This prospective, observational study was conducted in KIMS, Bhubaneswar, India, from January 2021 to November 2022. Children of 2-12 years of age were treated with monotherapy of either newer antiepileptics, e.g., levetiracetam, topiramate, and oxcarbazepine or older antiepileptics, e.g., valproic acid, phenytoin, phenobarbital, and carbamazepine. Univariate and multivariate analyses were performed for the assessment of predictors. We used R software (version 4.1.1) for data analysis.
RESULTS: One hundred and ninety-eight (91.7%) of 216 enrolled participants completed this study. The mean age of the study population was 5.2 years and 117 (59%) of them were males. The univariate analysis showed that male gender, low birth weight, preterm birth, assisted vaginal delivery and site-specific epilepsy, and maternal history of epilepsy were significant predictors of combination therapy and reduced seizure-free period. There was a non-significant difference regarding the improvement of QOLCE-55 scores. None of the adverse events were serious.
CONCLUSIONS: Perinatal complications and maternal history of epilepsy contribute significantly toward the efficacy of antiepileptics. However, multivariate analysis did not yield statistically significant results.
METHODS: This prospective, observational study was conducted in KIMS, Bhubaneswar, India, from January 2021 to November 2022. Children of 2-12 years of age were treated with monotherapy of either newer antiepileptics, e.g., levetiracetam, topiramate, and oxcarbazepine or older antiepileptics, e.g., valproic acid, phenytoin, phenobarbital, and carbamazepine. Univariate and multivariate analyses were performed for the assessment of predictors. We used R software (version 4.1.1) for data analysis.
RESULTS: One hundred and ninety-eight (91.7%) of 216 enrolled participants completed this study. The mean age of the study population was 5.2 years and 117 (59%) of them were males. The univariate analysis showed that male gender, low birth weight, preterm birth, assisted vaginal delivery and site-specific epilepsy, and maternal history of epilepsy were significant predictors of combination therapy and reduced seizure-free period. There was a non-significant difference regarding the improvement of QOLCE-55 scores. None of the adverse events were serious.
CONCLUSIONS: Perinatal complications and maternal history of epilepsy contribute significantly toward the efficacy of antiepileptics. However, multivariate analysis did not yield statistically significant results.
摘要：
目标：目前，我们缺乏有关儿科人群中新型抗癫痫药物(AEDs)的全面信息.这可能解释了儿科医生在这方面的偏好之间的差异。因此,研究这些药物对儿童的多方面影响至关重要。我们研究的终点是癫痫发作管理需要联合治疗的非AED预测因子，无癫痫发作期>6个月和>12个月，儿童癫痫问卷中的生活质量变化-55(QOLCE-55)，和不良事件的发生率。
方法：这种前瞻性，观察性研究在KIMS中进行，布巴内斯瓦尔,印度,从2021年1月到2022年11月。2-12岁的儿童接受了两种新型抗癫痫药的单药治疗，例如，左乙拉西坦,托吡酯,和奥卡西平或更老的抗癫痫药，例如，丙戊酸,苯妥英,苯巴比妥,和卡马西平.进行单变量和多变量分析以评估预测因子。我们使用R软件（4.1.1版）进行数据分析。
结果：216名参与者中有一百九十八名（91.7%）完成了这项研究。研究人群的平均年龄为5.2岁，其中117人（59%）为男性。单因素分析显示,男性性别,低出生体重,早产,辅助阴道分娩和特定部位癫痫，和母亲的癫痫病史是联合治疗和减少无癫痫发作期的重要预测因素。关于QOLCE-55评分的改善没有显著差异。无严重不良事件。
结论：围产期并发症和母亲癫痫史对抗癫痫药的疗效有显著影响。然而,多变量分析没有产生统计学上显著的结果。
方法：这种前瞻性，观察性研究在KIMS中进行，布巴内斯瓦尔,印度,从2021年1月到2022年11月。2-12岁的儿童接受了两种新型抗癫痫药的单药治疗，例如，左乙拉西坦,托吡酯,和奥卡西平或更老的抗癫痫药，例如，丙戊酸,苯妥英,苯巴比妥,和卡马西平.进行单变量和多变量分析以评估预测因子。我们使用R软件（4.1.1版）进行数据分析。
结果：216名参与者中有一百九十八名（91.7%）完成了这项研究。研究人群的平均年龄为5.2岁，其中117人（59%）为男性。单因素分析显示,男性性别,低出生体重,早产,辅助阴道分娩和特定部位癫痫，和母亲的癫痫病史是联合治疗和减少无癫痫发作期的重要预测因素。关于QOLCE-55评分的改善没有显著差异。无严重不良事件。
结论：围产期并发症和母亲癫痫史对抗癫痫药的疗效有显著影响。然而,多变量分析没有产生统计学上显著的结果。
