Kohn Elkana, Lezinger Mirit, Daniel Sharon, Masarwi Majdi, Brandriss Nurit, Bar-Chaim Adina, Berkovitch Matitiahu, Heyman Eli, Komargodski Rinat
Clinical Pharmacology and Toxicology Unit, Shamir Medical Center (Assaf Harofeh), Zerifin, Israel.
Pediatric Neurology Department, Shamir Medical Center (Assaf Harofeh), Zerifin, Israel.
Front Pharmacol. 2023 Jul 6;14:1164902. doi: 10.3389/fphar.2023.1164902. eCollection 2023.
This study aimed to investigate the efficacy and tolerability of Lacosamide (LCM) in a pediatric population with epilepsy using LCM serum concentration and its correlation to the age of the participants and the dosage of the drug. Demographic and clinical data were collected from the medical records of children with epilepsy treated with LCM at Shamir Medical Center between February 2019 to September 2021, in whom medication blood levels were measured. Trough serum LCM concentration was measured in the biochemical laboratory using High-Performance Liquid Chromatography (HPLC) and correlated with the administered weight-based medication dosing and clinical report. Forty-two children aged 10.43 ± 5.13 years (range: 1-18) were included in the study. The average daily dose of LCM was 306.62 ± 133.20 mg (range: 100-600). The average number of seizures per day was 3.53 ± 7.25 compared to 0.87 ± 1.40 before and after LCM treatment, respectively. The mean LCM serum concentration was 6.74 ± 3.27 mg/L. No statistically significant association was found between LCM serum levels and the clinical response ( = 0.58), as well as the correlation between LCM dosage and the change in seizure rate ( = 0.30). Our study did not find a correlation between LCM serum concentration and LCM dosage and the gender of the participants: males (n = 17) females (n = 23) ( = 0.31 and = 0.94, respectively). A positive trend was found between age and LCM serum concentrations (r = 0.26, = 0.09). Based on the data that has been obtained from our study, it appears that therapeutic drug monitoring for LCM may not be necessary. Nonetheless, further research in this area is needed in the light of the relatively small sample size of the study.
本研究旨在通过拉科酰胺（LCM）血清浓度及其与参与者年龄和药物剂量的相关性，调查LCM在小儿癫痫患者中的疗效和耐受性。从2019年2月至2021年9月在沙米尔医疗中心接受LCM治疗的癫痫患儿的病历中收集人口统计学和临床数据，这些患儿的药物血药浓度已被测量。在生化实验室使用高效液相色谱法（HPLC）测量LCM血清谷浓度，并将其与基于体重的给药剂量和临床报告相关联。42名年龄为10.43±5.13岁（范围：1 - 18岁）的儿童被纳入研究。LCM的平均日剂量为306.62±133.20毫克（范围：100 - 600）。治疗前、后每天癫痫发作的平均次数分别为3.53±7.25次和0.87±1.40次。LCM血清平均浓度为6.74±3.27毫克/升。未发现LCM血清水平与临床反应之间存在统计学显著关联（P = 0.58），以及LCM剂量与癫痫发作率变化之间的相关性（P = 0.30）。我们的研究未发现LCM血清浓度和LCM剂量与参与者性别之间存在相关性：男性（n = 17）女性（n = 23）（分别为P = 0.31和P = 0.94）。年龄与LCM血清浓度之间发现了正相关趋势（r = 0.26，P = 0.09）。基于我们研究获得的数据，似乎对LCM进行治疗药物监测可能没有必要。尽管如此，鉴于本研究样本量相对较小，该领域仍需要进一步研究。
