Yasumoto Sawa, Ohtsuka Yoko, Sato Katsuaki, Kurata Atsuyo, Numachi Yotaro, Shimizu Masahiro
Department of Pediatrics, School of Medicine, Fukuoka University, Fukuoka, Japan.
Department of Child Neurology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Brain Dev. 2018 Oct;40(9):786-791. doi: 10.1016/j.braindev.2018.05.005. Epub 2018 May 31.
To investigate the efficacy and safety of long-term lamotrigine (LTG) monotherapy in Japanese and South Korean pediatric patients with newly diagnosed typical absence seizures.
Six Japanese patients and one South Korean patient were enrolled in the extension phase of the study after completing the 12-week maintenance phase of an open-label clinical study of LTG monotherapy. During the extension phase, patients underwent efficacy and safety evaluation every 12 weeks.
Of the seven patients, six patients completed the extension phase. The seizure-free rate confirmed by hyperventilation (HV)-electroencephalography ranged from 71.4% to 100.0% at each visit up to Week 168 of the extension phase. Similar effects were confirmed by HV-clinical signs and seizure diaries. Although no unexpected adverse events were observed, one Japanese patient was withdrawn from the extension phase due to mild drug-related rash developed 842 days after the start of LTG.
Although the number of patients is limited, long-term LTG monotherapy appeared to be effective and generally well tolerated in Japanese and South Korean pediatric patients with typical absence seizures.
探讨长期拉莫三嗪（LTG）单药治疗对日本和韩国新诊断的典型失神发作儿科患者的疗效和安全性。
6名日本患者和1名韩国患者在完成LTG单药治疗的开放标签临床研究的12周维持期后进入该研究的延长期。在延长期，患者每12周接受一次疗效和安全性评估。
7名患者中，6名患者完成了延长期。在延长期第168周之前的每次随访中，通过过度换气（HV）-脑电图确认的无癫痫发作率为71.4%至100.0%。通过HV-临床体征和癫痫发作日记也证实了类似的效果。虽然未观察到意外不良事件，但1名日本患者在开始LTG治疗842天后因出现轻度药物相关皮疹而退出延长期。
尽管患者数量有限，但长期LTG单药治疗对日本和韩国典型失神发作儿科患者似乎有效且总体耐受性良好。
