Bruni J
Wellesly Hospital, Toronto, Ontario, Canada.
Can J Neurol Sci. 1998 May;25(2):134-40.
The safety, tolerability, efficacy, and impact on quality of life of gabapentin (Neurontin) as adjunctive therapy to carbamazepine (CBZ) and/or phenytoin (PHT) was assessed in epileptic patients with partial seizures.
NEON (Neurontin Evaluation of Outcomes in Neurological Practice) was an open-label, prospective, multicentre study conducted in patients on a stable dose of CBZ and/or PHT and experiencing an average of up to 4 complex partial seizures with or without secondary generalization per month, with no seizure-free months. The treatment lasted 20 weeks. Gabapentin was started at 400 mg/day and was individually titrated to effective tolerable dose up to 2400 mg/day. Quality of life was evaluated using the QOLIE-10 questionnaire.
A total of 141 patients were enrolled at 36 sites; 114 patients were evaluable for efficacy analyses. The mean maintenance dose of gabapentin was 1600 mg/day (range = 300-3200). A decrease of 50% or more in frequency of complex partial + secondary generalized seizures was observed in 81 (71%) patients (p = 0.0001). Fifty two (46%) patients were seizure-free during the last 8 weeks of treatment. A significant improvement (p < 0.05) was observed in 5 of the 10 questions of the QOLIE-10, as well as in the composite QOL score (p = 0.0002). The most frequent adverse events included somnolence (16%), dizziness (9%), and asthenia (6%). Twenty-five (18%) patients prematurely discontinued the study, 16 (11%) of them due to adverse events.
This study indicates that treatment with gabapentin as adjunctive therapy to standard antiepileptic drugs in this group of patients not only provides significant improvement in seizure control, but also has a positive impact on quality of life. The clinical benefits in efficacy, safety and tolerability demonstrated at 20 weeks are sustained, and no tolerance develops with gabapentin in longer term use.
评估加巴喷丁（Neurontin）作为卡马西平（CBZ）和/或苯妥英钠（PHT）辅助治疗对部分性发作癫痫患者的安全性、耐受性、疗效及生活质量的影响。
NEON（神经科实践中加巴喷丁疗效评估）是一项开放标签、前瞻性、多中心研究，研究对象为服用稳定剂量CBZ和/或PHT且每月平均发生多达4次复杂部分性发作（伴或不伴继发全面性发作）且无无发作月的患者。治疗持续20周。加巴喷丁起始剂量为400mg/天，并根据个体情况滴定至有效耐受剂量，最高可达2400mg/天。使用QOLIE-10问卷评估生活质量。
36个研究点共纳入141例患者；114例患者可进行疗效分析。加巴喷丁的平均维持剂量为1600mg/天（范围=300-3200）。81例（71%）患者的复杂部分性发作+继发全面性发作频率降低了50%或更多（p=0.0001）。52例（46%）患者在治疗的最后8周无发作。QOLIE-10的10个问题中有5个以及综合生活质量评分有显著改善（p<0.05）（p=0.0002）。最常见的不良事件包括嗜睡（16%）、头晕（9%）和乏力（6%）。25例（18%）患者提前终止研究，其中16例（11%）因不良事件终止。
本研究表明在该组患者中，加巴喷丁作为标准抗癫痫药物的辅助治疗不仅能显著改善癫痫控制，还对生活质量有积极影响。20周时在疗效、安全性和耐受性方面显示的临床益处可持续，长期使用加巴喷丁不会产生耐受性。
