Yang Chunsong, Liu Zheng, Peng Yuxuan, Zhang Lingli, Yu Dan
Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, China.
Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China.
Front Pharmacol. 2023 Aug 9;14:1186768. doi: 10.3389/fphar.2023.1186768. eCollection 2023.
To compare the effectiveness and safety of the new antiepileptic drug, lacosamide (LCM) with Levetiracetam, for the treatment of focal epilepsy in children. This study was a cohort study. Children with focal epilepsy who received LCM or Levetiracetam treatment in West China Second Hospital of Sichuan University were recruited and followed up for 12 months. Changes in the frequency of epilepsy, 50% and 75% responder rates, and seizure freedom rates from baseline to the maintenance period and adherence score were assessed. In addition, adverse events (AEs) were recorded. 92 patients completed the study, and were divided into two groups: LCM ( = 46) and Levetiracetam ( = 46). Participants were aged from 2 to 16.3 years, with a mean epilepsy duration of 2.57 years. The average maintenance dose of LCM was 5.03 ± 1.91 mg/kg/d after the titration period. There was no significant difference between the two groups in terms of the mean seizure frequency during subsequent visits at 1, 3,6, 9, 12 months. There was significant difference between the two groups in terms of the 50% responder rate at 6 months. No serious AEs were reported in both groups. The vast majority of patients had good adherence (adherence score = 4) in the LCM group. LCM is effective as adjunctive therapy in children with epilepsy and has good safety, tolerability and adherence. Large sample size studies with long-term follow-up are needed in the future to comprehensively evaluate the use of LCM in children. : [https://www.chictr.org.cn/showproj.html?proj=41041], identifier [ChiCTR1900024507].
比较新型抗癫痫药物拉科酰胺(LCM)与左乙拉西坦治疗儿童局灶性癫痫的有效性和安全性。本研究为队列研究。招募在四川大学华西第二医院接受LCM或左乙拉西坦治疗的局灶性癫痫患儿,并随访12个月。评估癫痫发作频率的变化、50%和75%缓解率、从基线到维持期的无癫痫发作率以及依从性评分。此外,记录不良事件(AE)。92例患者完成研究,分为两组:LCM组(n = 46)和左乙拉西坦组(n = 46)。参与者年龄为2至16.3岁,平均癫痫病程为2.57年。滴定期后LCM的平均维持剂量为5.03±1.91mg/kg/d。在随后1、3、6、9、12个月的随访中,两组的平均癫痫发作频率无显著差异。两组在6个月时的50%缓解率有显著差异。两组均未报告严重不良事件。LCM组绝大多数患者依从性良好(依从性评分 = 4)。LCM作为儿童癫痫的辅助治疗有效,具有良好的安全性、耐受性和依从性。未来需要进行大样本量的长期随访研究,以全面评估LCM在儿童中的应用。试验注册:[https://www.chictr.org.cn/showproj.html?proj=41041],标识符[ChiCTR1900024507]