Nakken K O, Lindstrøm P, Andersen H
National Centre for Epilepsy, Sandvika, Norway.
Acta Neurol Scand. 2015 May;131(5):268-74. doi: 10.1111/ane.12379. Epub 2015 Feb 3.
To assess the effect and tolerability of zonisamide (ZNS) as adjunctive treatment for difficult-to-treat epilepsy in adult Scandinavian patients.
151 outpatients (mean age: 42.5 years) from 18 centres in Denmark, Sweden and Norway were recruited to the study. 81.5% had focal epilepsy, and the mean number of previously tried AEDs was 4.5. The patients were given ZNS as add-on treatment, and the ZNS dosing and the visit frequency were governed by the treating physician. The primary efficacy endpoint was the retention rate after 12-month treatment. Assessments included also responder rate, type and frequency of adverse events, healthcare resource utilization (HCRU) and quality of life (QOLIE-31).
90 patients (59.6%) completed the study. Mean daily ZNS dose was 300.8 mg. After 12 months, 81 patients were still on ZNS, that is a retention rate of 53.6%. The mean reduction of seizure frequency at 12 months was 27%. Best effect was seen in those with focal and those with secondary generalized seizures. In the QOLIE-31, there was a mean increase from baseline of 4.8 points. The tolerability was generally good. The majority of side effects were CNS-related, dizziness, fatigue, seizure aggravation, and headache being most prevalent. 21.2% had adverse events leading to withdrawal of ZNS.
A retention rate of 53.6% after 1 year of treatment with ZNS is roughly in accordance with the retention rates found for lamotrigine, oxcarbazepine, levetiracetam and topiramate in drug-resistant patients.
评估唑尼沙胺（ZNS）作为辅助治疗药物用于斯堪的纳维亚成年难治性癫痫患者的疗效和耐受性。
招募了来自丹麦、瑞典和挪威18个中心的151名门诊患者（平均年龄：42.5岁）。81.5%的患者患有局灶性癫痫，之前尝试使用抗癫痫药物（AEDs）的平均数量为4.5种。患者接受ZNS作为附加治疗，ZNS的给药剂量和就诊频率由主治医生决定。主要疗效终点是12个月治疗后的留存率。评估还包括缓解率、不良事件的类型和频率、医疗资源利用（HCRU）以及生活质量（QOLIE-31）。
90名患者（59.6%）完成了研究。ZNS的平均日剂量为300.8毫克。12个月后，81名患者仍在服用ZNS，即留存率为53.6%。12个月时癫痫发作频率的平均降低率为27%。在局灶性癫痫患者和继发性全身性癫痫患者中观察到最佳疗效。在QOLIE-31量表中，与基线相比平均增加了4.8分。耐受性总体良好。大多数副作用与中枢神经系统相关，头晕、疲劳、癫痫发作加重和头痛最为常见。21.2%的患者因不良事件而停用ZNS。
ZNS治疗1年后53.6%的留存率大致与耐药患者中拉莫三嗪、奥卡西平、左乙拉西坦和托吡酯的留存率相符。
