佐尼沙胺辅助治疗成人耐药性部分性癫痫发作的疗效和安全性：一项随机、双盲、安慰剂对照试验。
Efficacy and safety of adjunctive zonisamide in adult patients with refractory partial-onset epilepsy: a randomized, double-blind, placebo-controlled trial.
机构信息
Department of Geriatrics, The First Affiliated Hospital, Chongqing Medical University, Chongqing, Peoples Republic of China.
出版信息
Clin Drug Investig. 2011;31(4):221-9. doi: 10.2165/11539750-000000000-00000.
BACKGROUND AND OBJECTIVE
Clinical studies have reported that zonisamide is effective for a wide range of seizure types, including refractory partial-onset seizures. However, there have been no reported studies of the efficacy of zonisamide in the Chinese population to date. The aim of the present study was to evaluate the efficacy and safety of zonisamide in the treatment of adult Chinese patients with refractory partial-onset epilepsy.
METHODS
This was a randomized, double-blind, placebo-controlled trial conducted over a 16-week period. 104 patients with refractory partial-onset epilepsy were enrolled. Participants were randomly assigned to receive add-on zonisamide or placebo. Zonisamide was titrated to a target dosage of 300 or 400 mg/day. Seizure frequency and adverse effects were documented.
RESULTS
102 patients completed the trial. Zonisamide showed significantly greater efficacy compared with placebo (responder rate 55.8% vs 36.0%, p<0.05), including 55.2% (16 of 29 patients) in the zonisamide 300 mg/day arm and 56.5% (13 of 23 patients) in the zonisamide 400 mg/day arm. Zonisamide 300 and 400 mg/day showed similar efficacy (p>0.05). Moreover, similar efficacy of zonisamide was found in the control of complex partial seizures, simple partial seizures and secondary generalized seizures. There was no difference in the incidence of adverse effects between zonisamide and placebo. Reported adverse effects in the zonisamide group involved the digestive system (32.5% of total adverse effects in the group) [including transient increases in liver enzymes (27.8%)], weight changes (30.2%), the haematological system (15.1%), neurological/psychiatric effects (10.3%), the urinary system (7.9%) and the cardiovascular system (4.0%). Only digestive system adverse effects constituted a significantly higher proportion of adverse effects in the zonisamide group than in the placebo group (32.5% vs 30.2%, p<0.05).
CONCLUSION
Zonisamide 300-400 mg/day is effective and well tolerated as an adjunctive drug in adult Chinese patients with refractory partial-onset epilepsy.
背景与目的
临床研究表明，佐米曲普坦对多种癫痫发作类型均有效，包括耐药性部分发作。然而，迄今为止，尚未有研究报道佐米曲普坦在中国人中的疗效。本研究旨在评估佐米曲普坦治疗成人耐药性部分发作性癫痫的疗效和安全性。
方法
这是一项为期 16 周的随机、双盲、安慰剂对照试验。共纳入 104 例耐药性部分发作性癫痫患者。参与者被随机分配接受佐米曲普坦或安慰剂添加治疗。佐米曲普坦滴定至目标剂量 300 或 400mg/天。记录癫痫发作频率和不良反应。
结果
102 例患者完成了试验。与安慰剂相比，佐米曲普坦显示出显著更好的疗效（应答率 55.8%比 36.0%，p<0.05），包括佐米曲普坦 300mg/天组的 55.2%（29 例中的 16 例）和佐米曲普坦 400mg/天组的 56.5%（23 例中的 13 例）。佐米曲普坦 300 和 400mg/天的疗效相似（p>0.05）。此外，佐米曲普坦在控制复杂部分性发作、简单部分性发作和继发性全面性发作方面具有相似的疗效。佐米曲普坦与安慰剂组之间不良反应的发生率无差异。佐米曲普坦组报告的不良反应涉及消化系统（占该组总不良反应的 32.5%）[包括短暂性肝酶升高（27.8%）]、体重变化（30.2%）、血液系统（15.1%）、神经/精神影响（10.3%）、泌尿系统（7.9%）和心血管系统（4.0%）。只有消化系统不良反应在佐米曲普坦组的比例明显高于安慰剂组（32.5%比 30.2%，p<0.05）。
结论
佐米曲普坦 300-400mg/天作为成人耐药性部分发作性癫痫的辅助药物，疗效好，耐受性好。
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