Larkin J G, McKee P J, Blacklaw J, Thompson G G, Morgan I C, Brodie M J
University Department of Medicine and Therapeutics, Western Infirmary, Glasgow, Scotland.
Epilepsy Res. 1991 May-Jun;9(1):71-7. doi: 10.1016/0920-1211(91)90049-l.
Twenty-two patients (8 male, 14 female) with refractory epilepsy entered a balanced, double-blind, placebo-controlled crossover trial of nimodipine as adjunctive therapy. Treatment periods of 12 weeks (nimodipine 30 mg tds, 60 mg tds, 90 mg tds each for 4 weeks and matched placebo) were followed by wash-out intervals of 4 weeks. Five patients withdrew (2 side-effects, 1 intercurrent illness, 2 non-compliance). Median values (placebo vs. nimodipine) did not vary for total (17 vs. 18), partial (14 vs. 18) and generalised tonic-clonic seizures (2 vs. 5) or seizure days (13 vs. 13). Monthly analysis also failed to uncover any benefit for nimodipine. Side-effects were reported no more frequently with nimodipine than with placebo and pulse and blood pressure did not alter significantly. Antiepileptic drug levels were not affected by nimodipine treatment but circulating nimodipine concentrations were low. In this trial, nimodipine did not fulfil the promise of its success in animal models of epilepsy. Enzyme induction by concurrent antiepileptic therapy may provide an explanation.
22例难治性癫痫患者（8例男性，14例女性）进入一项关于尼莫地平作为辅助治疗的均衡、双盲、安慰剂对照交叉试验。治疗期为12周（尼莫地平30毫克每日三次、60毫克每日三次、90毫克每日三次各4周，并给予匹配的安慰剂），随后是4周的洗脱期。5例患者退出（2例出现副作用，1例并发疾病，2例不依从）。总发作次数（17次对18次）、部分性发作次数（14次对18次）、全身性强直阵挛发作次数（2次对5次）或发作天数（13天对13天）的中位数（安慰剂对尼莫地平）无差异。每月分析也未发现尼莫地平有任何益处。尼莫地平报告的副作用频率并不高于安慰剂，脉搏和血压也无显著变化。抗癫痫药物水平不受尼莫地平治疗影响，但循环中的尼莫地平浓度较低。在该试验中，尼莫地平并未实现其在癫痫动物模型中的成功前景。同时进行的抗癫痫治疗引起的酶诱导作用可能是一个解释。
