Abstract：
Due to the limited number of studies in children with focal epilepsy and the importance of choosing the most suitable drug to control seizures in children, the administration of the most effective medication with the most negligible adverse events is vital. This study aimed to evaluate the effectiveness and adverse events of carbamazepine vs. levetiracetam monotherapy in children with focal seizures. A monocentric, randomized, controlled, double-blind, parallel-group clinical trial was designed. This study was approved by the Iranian Registry of Clinical Trials (registration number: IRCT20170216032603N2) on June 19, 2020, and conducted at the neurology department of Imam Ali Hospital, Karaj, Iran, from February 2020 to March 2021. This study assessed 120 patients with recently diagnosed focal seizures aged 2 to 14. Patients were randomly divided into two groups, who received carbamazepine (CBZ) 15 to 20 mg/kg and levetiracetam (LEV) 20 to 40 mg/kg daily, respectively. Patients were evaluated for improvement and complications at weeks 4, 12, and 24. Out of 120 patients included in the study, six patients were excluded due to various complications of CBZ. The mean number of seizures at the end of the fourth, twelfth, and twenty-fourth weeks were 1.09 ± 0.75, 0.62 ± 0.27, and 0.39 ± 0.12 in the carbamazepine group and 1.11 ± 0.63, 0.52 ± 0.21, and 0.37 ± 0.11 in the LEV group, respectively (P > 0.05). Similarly, the number of seizure-free patients was 34, 44, and 48 in the CBZ group compared to 41, 50, and 54 in the LEV group, respectively (P > 0.05). On the other hand, the frequency of somnolence, dermatologic complications, and agitation was considerably higher in the CBZ group (P < 0.05). Although both medicines were equally effective in seizure control, CBZ was associated with considerably more adverse events and less patient compliance. Physicians should be aware of this difference to prevent unwanted consequences.
摘要：
由于对局灶性癫痫儿童的研究数量有限，以及选择最合适的药物控制儿童癫痫发作的重要性，使用最有效的药物和最可忽略的不良事件至关重要.这项研究旨在评估卡马西平与卡马西平的有效性和不良事件。左乙拉西坦单药治疗局灶性癫痫患儿。一个单心人，随机化，控制,双盲,设计了平行组临床试验.这项研究于2020年6月19日获得伊朗临床试验注册中心（注册号：IRCT20170216032603N2）的批准，并在伊玛目阿里医院神经内科进行。卡拉杰,伊朗,从2020年2月到2021年3月。这项研究评估了120名最近诊断为2至14岁的局灶性癫痫患者。将患者随机分为两组,每天接受卡马西平（CBZ）15至20mg/kg和左乙拉西坦（LEV）20至40mg/kg，分别。在第4、12和24周评估患者的改善和并发症。在纳入研究的120名患者中，6例患者因CBZ的各种并发症被排除.第四次结束时的平均癫痫发作次数，第十二,第24周，卡马西平组分别为1.09±0.75、0.62±0.27和0.39±0.12，LEV组分别为1.11±0.63、0.52±0.21和0.37±0.11，分别为(P>0.05)。同样，CBZ组中无癫痫发作患者的数量为34、44和48，而LEV组中为41、50和54，分别为(P>0.05)。另一方面,嗜睡的频率，皮肤病学并发症，CBZ组躁动明显增高(P<0.05)。尽管两种药物在控制癫痫发作方面同样有效，CBZ与相当多的不良事件和较少的患者依从性相关。医生应该意识到这种差异，以防止不必要的后果。
