Department of Pediatrics, Korea University College of Medicine, Republic of Korea.
Seizure. 2011 Sep;20(7):558-63. doi: 10.1016/j.seizure.2011.04.005. Epub 2011 May 4.
To evaluate the effectiveness of zonisamide (ZNS) as monotherapy in children with newly diagnosed epilepsy.
This randomized, multicenter trial included a 2-4-week titration and a 24-week maintenance phase after randomization to low-(3-4 mg/kg/day) or high-(6-8 mg/kg/day) dose groups as target maintenance dosages. The primary outcome measure was the seizure-free rate over 6 months, while a secondary measure was the change in cognition and behavior from screening to the end of the maintenance phase.
Out of 125 patients enrolled, 90 (49 low-dose and 41 high-dose) completed the study. Forty-one patients (63.1%) in the low-dose group and 34(57.6%) in the high-dose group achieved 6 months' freedom from seizures (p=0.66). After treatment, the picture arrangement subtest improved in the low-dose group (p=0.047) while the vocabulary subtest worsened in the high-dose group (p=0.020). Comparing between the two groups, the vocabulary subtest in the high-dose group was significantly worse than that in the low-dose group (p=0.002). Social competence, somatic complaints, depression/anxiety and delinquent and aggressive behavior in the low-dose group were significantly improved (p<0.05). Moreover, total social competence, somatic complaints, delinquent behavior, externalizing, and total behavior problems were significantly more improved in the low-dose group than the high-dose group (p<0.05).
ZNS is an effective monotherapy for newly diagnosed childhood epilepsy. Lower doses of ZNS have a similar efficacy and more beneficial neurocognitive effects compared to higher doses. When prescribing higher doses of ZNS, one must be aware of the possible manifestation of problems associated with language development, such as those affecting vocabulary acquisition.
评估佐尼沙胺（ZNS）作为新诊断癫痫患儿单药治疗的有效性。
这是一项随机、多中心试验，包括 2-4 周的滴定期和随机分组后 24 周的维持期，目标维持剂量分为低剂量（3-4mg/kg/天）和高剂量（6-8mg/kg/天）组。主要结局指标为 6 个月无发作率，次要结局指标为从筛查到维持期末认知和行为的变化。
125 例患者中，90 例（低剂量组 49 例，高剂量组 41 例）完成了研究。低剂量组有 41 例（63.1%）和高剂量组有 34 例（57.6%）患者在 6 个月内无发作（p=0.66）。治疗后，低剂量组图片排列测验（picture arrangement subtest）改善（p=0.047），而高剂量组词汇测验（vocabulary subtest）恶化（p=0.020）。两组比较，高剂量组词汇测验明显差于低剂量组（p=0.002）。低剂量组社会能力、躯体主诉、抑郁/焦虑和违纪及攻击行为明显改善（p<0.05）。此外，低剂量组的总社会能力、躯体主诉、违纪行为、外显行为和总行为问题均明显优于高剂量组（p<0.05）。
ZNS 是新诊断儿童癫痫的有效单药治疗。与高剂量相比，低剂量 ZNS 具有相似的疗效和更有益的神经认知作用。当处方更高剂量的 ZNS 时，必须注意可能出现与语言发展相关的问题的表现，如影响词汇习得的问题。
