Department of Neurology Children's Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Chongqing Key Laboratory of Child Neurodevelopment and Cognitive Disorders, Big Data Engineering Center, Children's Hospital of Chongqing Medical University, Chongqing, China.
Guangdong Provincial Key Laboratory of Interdisciplinary Research and Application for Data Science, BNU-HKBU United International College, Zhuhai, China.
CNS Neurosci Ther. 2024 Aug;30(8):e14917. doi: 10.1111/cns.14917.
To evaluate the efficacy, safety, and tolerability of adjunctive lacosamide therapy against focal seizures in young children (1 month - 4 years).
This non-randomized, open-label, and self-controlled real-world study included 105 children (1 month-4 years) with focal seizures treated with adjunctive lacosamide therapy at Children's Hospital of Chongqing Medical University.
(1) The 50% response rates at 3, 6, 9, and 12 months of follow-up were 58.1%, 61.0%, 57.1%, and 56.2%, while the seizure-free rates were 27.6%, 34.3%, 32.4%, and 37.1%, respectively. The 50% response rate of the first addition of lacosamide for focal seizures was much higher than the second and later added treatment at 3 months (p = 0.038). After 1 year of follow-up, these children showed an improvement in neurodevelopmental levels (p < 0.05). (2) Lacosamide retention rate was 72.7% (64/88) after 1 year of follow-up. Lack of efficacy and serious adverse events were independent risk factors for the lacosamide retention rate. (3) During adjunctive lacosamide therapy, 13 (12.4%) patients reported adverse events and five (4.7%) patients withdrew due to adverse events, including vomiting drowsiness, ataxia (0.94%), neck itching with eczema (0.94%), irritability (1.88%), and gastrointestinal discomfort (0.94%).
Adjunctive lacosamide therapy was effective, safe, and well-tolerated in young Chinese children with focal seizures in this study.
评估拉科酰胺辅助治疗小儿局灶性发作（1 个月至 4 岁）的疗效、安全性和耐受性。
本项非随机、开放标签、自身对照的真实世界研究纳入了 105 例在重庆医科大学附属儿童医院接受拉科酰胺辅助治疗的局灶性发作患儿（1 个月至 4 岁）。
（1）随访 3、6、9 和 12 个月时，50%反应率分别为 58.1%、61.0%、57.1%和 56.2%，而无发作率分别为 27.6%、34.3%、32.4%和 37.1%。拉科酰胺首次添加治疗局灶性发作的 50%反应率在 3 个月时明显高于第二次及以后添加治疗（p=0.038）。随访 1 年后，这些儿童的神经发育水平有所改善（p<0.05）。（2）随访 1 年后，拉科酰胺保留率为 72.7%（64/88）。疗效不佳和严重不良事件是拉科酰胺保留率的独立危险因素。（3）在拉科酰胺辅助治疗期间，13 例（12.4%）患者报告发生不良事件，5 例（4.7%）患者因不良事件（包括呕吐、嗜睡、共济失调[0.94%]、颈部瘙痒伴湿疹[0.94%]、烦躁[1.88%]和胃肠道不适[0.94%]）停药。
在本研究中，拉科酰胺辅助治疗中国小儿局灶性发作有效、安全且耐受良好。
