Chadwick D, Leiderman D B, Sauermann W, Alexander J, Garofalo E
Department of Medical and Surgical Neurology, Walton Hospital, Liverpool, UK.
Epilepsy Res. 1996 Nov;25(3):191-7. doi: 10.1016/s0920-1211(96)00020-4.
The efficacy of gabapentin (Neurontin), in generalized seizures was evaluated in this 14 week, double-blind, placebo-controlled, parallel-group, add-on, multicenter study. A total of 129 patients with refractory generalized seizures were randomized to receive either placebo or 1200 mg/day gabapentin as add-on therapy. Patients received their standard regimens of antiepileptic drugs (AEDs) during a 12 week baseline period, and gabapentin or placebo was added-on in the subsequent 14 week evaluation period. Results of both an intent-to-treat (ITT) and evaluable-patient analyses showed that gabapentin provided greater reduction in the frequency of generalized tonic-clonic seizures than did placebo; however, the differences between treatments were not statistically significant. Gabapentin did not affect the frequency of absence or myoclonic seizures. Adverse events were reported by 67% of gabapentin-treated patients and by 56% of placebo-treated patients. The most frequently occurring adverse events among patients receiving gabapentin were somnolence, fatigue, and dizziness. Gabapentin is well tolerated by patients with generalized seizures. The results of this study show a trend toward an effect of gabapentin in reducing the frequency of generalized tonic-clonic seizures and suggest that further exploration of high dose gabapentin in generalized epilepsy is warranted.
在这项为期14周的双盲、安慰剂对照、平行组、附加治疗的多中心研究中，评估了加巴喷丁（Neurontin）治疗全身性癫痫发作的疗效。总共129例难治性全身性癫痫发作患者被随机分配接受安慰剂或1200毫克/日加巴喷丁作为附加治疗。患者在12周的基线期接受其标准的抗癫痫药物（AEDs）治疗方案，并在随后的14周评估期添加加巴喷丁或安慰剂。意向性治疗（ITT）分析和可评估患者分析的结果均显示，加巴喷丁比安慰剂能更显著地降低全身性强直阵挛性发作的频率；然而，治疗组之间的差异无统计学意义。加巴喷丁不影响失神发作或肌阵挛发作的频率。67%接受加巴喷丁治疗的患者和56%接受安慰剂治疗的患者报告了不良事件。接受加巴喷丁治疗的患者中最常出现的不良事件是嗜睡、疲劳和头晕。全身性癫痫发作患者对加巴喷丁耐受性良好。本研究结果显示加巴喷丁在降低全身性强直阵挛性发作频率方面有一定趋势，提示有必要进一步探索高剂量加巴喷丁治疗全身性癫痫的疗效。
