Meyer F B, Cascino G D, Whisnant J P, Sharbrough F W, Ivnik R J, Gorman D A, Windschitl W L, So E L, O'Fallon W M
Department of Neurologic Surgery, Mayo Clinic Rochester, MN 55905, USA.
Mayo Clin Proc. 1995 Jul;70(7):623-7. doi: 10.4065/70.7.623.
To analyze the effect of nimodipine in patients with intractable epilepsy.
We conducted a double-blind placebo-controlled crossover study in 95 patients.
The dihydropyridine calcium antagonist nimodipine was used as add-on therapy (60 mg four times a day) in a 1-year placebo-controlled crossover study in 71 patients with localization-related epilepsy and 24 with generalized seizure disorders. Of the 95 patients, 81 were receiving two or more antiepileptic drugs. Patients diaries were used to record the number of seizures and any side effects.
Nimodipine seemed to be well tolerated during the study; only two patients were unable to complete the study because of probable adverse effects. The trial demonstrated no significant crossover effect and no significant effect of nimodipine on either the mean or the median number of seizures or seizure days. The peak median serum nimodipine level was less than 5 ng/mL in the 78 patients who completed the study.
This clinical trial found no beneficial effect with use of nimodipine as add-on therapy for intractable epilepsy. Potential reasons for the absence of efficacy of nimodipine may be the inclusion of patients with very refractory seizure disorders or the relatively low serum nimodipine concentrations related to the pharmacokinetic effect of concurrent antiepileptic medication.
分析尼莫地平对难治性癫痫患者的疗效。
我们对95例患者进行了一项双盲安慰剂对照交叉研究。
在一项为期1年的安慰剂对照交叉研究中，二氢吡啶类钙拮抗剂尼莫地平作为附加疗法（每日4次，每次60毫克）用于71例局灶性相关性癫痫患者和24例全身性癫痫发作障碍患者。95例患者中，81例正在接受两种或更多种抗癫痫药物治疗。使用患者日记记录癫痫发作次数和任何副作用。
在研究期间，尼莫地平似乎耐受性良好；只有2例患者因可能的不良反应而无法完成研究。该试验未显示出显著的交叉效应，尼莫地平对癫痫发作的平均次数或中位数以及癫痫发作天数均无显著影响。在完成研究的78例患者中，血清尼莫地平水平的中位数峰值低于5纳克/毫升。
这项临床试验发现，使用尼莫地平作为难治性癫痫的附加疗法没有益处。尼莫地平缺乏疗效的潜在原因可能是纳入了癫痫发作非常难治的患者，或者与同时使用的抗癫痫药物的药代动力学效应相关的血清尼莫地平浓度相对较低。
