Rout Abhisek, Pattanayak Chaitali, Mishra Reshmi, Sahoo Jyoti Prakash, Das Mangala C
Pharmacology, Kalinga Institute of Medical Sciences, Bhubaneswar, IND.
Pharmacology and Therapeutics, Kalinga Institute of Medical Sciences, Bhubaneswar, IND.
Cureus. 2023 May 18;15(5):e39173. doi: 10.7759/cureus.39173. eCollection 2023 May.
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.
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.
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.
Perinatal complications and maternal history of epilepsy contribute significantly toward the efficacy of antiepileptics. However, multivariate analysis did not yield statistically significant results.
目前,我们缺乏关于儿科人群中新型抗癫痫药物(AEDs)的全面信息。这或许可以解释儿科医生在这方面偏好存在差异的原因。因此,研究这些药物对儿童的多方面影响至关重要。我们研究的终点包括癫痫发作管理联合治疗需求的非AED预测因素、无癫痫发作期>6个月和>12个月、儿童癫痫生活质量问卷-55(QOLCE-55)的变化以及不良事件的发生率。
这项前瞻性观察性研究于2021年1月至2022年11月在印度布巴内斯瓦尔的KIMS进行。2至12岁的儿童接受新型抗癫痫药物(如左乙拉西坦、托吡酯和奥卡西平)或传统抗癫痫药物(如丙戊酸、苯妥英、苯巴比妥和卡马西平)的单药治疗。进行单变量和多变量分析以评估预测因素。我们使用R软件(版本4.1.1)进行数据分析。
216名登记参与者中有198名(91.7%)完成了本研究。研究人群的平均年龄为5.2岁,其中117名(59%)为男性。单变量分析表明,男性性别、低出生体重、早产、助产阴道分娩和特定部位癫痫以及母亲癫痫病史是联合治疗和缩短无癫痫发作期的显著预测因素。QOLCE-55评分的改善无显著差异。所有不良事件均不严重。
围产期并发症和母亲癫痫病史对抗癫痫药物的疗效有显著影响。然而,多变量分析未得出具有统计学意义的结果。