"Efficacy, safety, and tolerability of adjunctive Lacosamide therapy for focal seizures in young children aged ≥1 month to ≤4 years: A real-world study"

作者全名："Yang, Lu; Liu, Yuhang; Deng, Yu; Peng, Xiaoling; Hu, Qiao; Jiang, Li; Hu, Yue"

作者地址："[Yang, Lu; Liu, Yuhang; Deng, Yu; Hu, Qiao; Jiang, Li; Hu, Yue] Chongqing Med Univ, Childrens Hosp,Big Data Engn Ctr, Natl Clin Res Ctr Child Hlth & Disorders,Chongqing, Dept Gastroenterol,Minist Educ,Key Lab Child Dev &, Chongqing, Peoples R China; [Peng, Xiaoling] BNU HKBU United Int Coll, Guangdong Prov Key Lab Interdisciplinary Res & App, Zhuhai, Peoples R China"

通信作者："Hu, Y (通讯作者)，Chongqing Med Univ, Childrens Hosp,Big Data Engn Ctr, Natl Clin Res Ctr Child Hlth & Disorders,Chongqing, Dept Gastroenterol,Minist Educ,Key Lab Child Dev &, Chongqing, Peoples R China."

来源：CNS NEUROSCIENCE & THERAPEUTICS

ESI学科分类：PHARMACOLOGY & TOXICOLOGY

WOS号：WOS:001287989100001

JCR分区：Q1

影响因子：5.5

年份：2024

卷号：30

期号：8

开始页：　

结束页：　

文献类型：Article

关键词：adjunctive therapy; children; focal seizures; lacosamide

摘要："Aims: To evaluate the efficacy, safety, and tolerability of adjunctive lacosamide therapy against focal seizures in young children (1 month - 4 years). Methods: 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. Results: (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%). Conclusion: Adjunctive lacosamide therapy was effective, safe, and well-tolerated in young Chinese children with focal seizures in this study."

基金机构：　

基金资助正文：We sincerely thank all the children and their parents for their cooperation in this study. The authors would like to thank all members who participated in this study.