Seki Tohru, Kumagai Noboru, Maezawa Mariko
Eijyu General Hospital, Tokyo, Japan.
Seizure. 2004 Dec;13 Suppl 1:S26-32; discussion S33. doi: 10.1016/j.seizure.2004.04.001.
This study examined the efficacy and safety of zonisamide as monotherapy in pediatric patients with epilepsy. Seventy-seven children with epilepsy (ages 8 months-15 years) were treated with zonisamide. Nine patients were withdrawn early because of side effects; these patients were included in side effect but not efficacy analyses. Zonisamide dosages were initiated at approximately 2 mg/kg per day and adjusted for each patient individually to a maximum of 12 mg/kg per day. Among 44 patients with cryptogenic/symptomatic partial epilepsy, 36 (82%) became seizure free; 4 (9%) had a > or =50% reduction in seizure frequency; and 4 (9%) had no change in seizures with zonisamide treatment. Of 11 patients with cryptogenic/symptomatic generalized epilepsy, 10 (91%) became seizure free, and 1 experienced no change with zonisamide treatment. Similarly, 4 patients (100%) with idiopathic partial epilepsy, and 8 of 9 patients (89%) with idiopathic generalized epilepsy became seizure free with zonisamide treatment; in the last group, 1 experienced no change. Thirty patients (39%) reported side effects, including somnolence (11.7%), decreased spontaneity (7.8%), anorexia (6.5%), and rash (6.5%). Thus, zonisamide is effective for partial seizures with or without secondarily generalized seizures in children and should be considered a broad-spectrum antiepilepsy agent.
本研究考察了唑尼沙胺作为单一疗法治疗小儿癫痫患者的疗效和安全性。77例癫痫患儿（年龄8个月至15岁）接受了唑尼沙胺治疗。9例患者因副作用提前退出；这些患者纳入副作用分析但未纳入疗效分析。唑尼沙胺剂量开始时约为每日2mg/kg，根据每位患者情况进行个体化调整，最大剂量为每日12mg/kg。在44例隐源性/症状性部分性癫痫患者中，36例（82%）无癫痫发作；4例（9%）癫痫发作频率降低≥50%；4例（9%）接受唑尼沙胺治疗后癫痫发作无变化。在11例隐源性/症状性全身性癫痫患者中，10例（91%）无癫痫发作，1例接受唑尼沙胺治疗后无变化。同样，4例特发性部分性癫痫患者（100%）以及9例特发性全身性癫痫患者中的8例（89%）接受唑尼沙胺治疗后无癫痫发作；最后一组中有1例无变化。30例患者（39%）报告有副作用，包括嗜睡（11.7%）、自发性降低（7.8%）、厌食（6.5%）和皮疹（6.5%）。因此，唑尼沙胺对儿童伴有或不伴有继发性全身性发作的部分性发作有效，应被视为一种广谱抗癫痫药物。
