VAGUS NERVE-STIMULATION FOR TREATMENT OF PARTIAL SEIZURES .1. A CONTROLLED-STUDY OF EFFECT ON SEIZURES
VAGUS NERVE-STIMULATION FOR TREATMENT OF PARTIAL SEIZURES .1. A CONTROLLED-STUDY OF EFFECT ON SEIZURES
复制标题
DOI：
10.1111/j.1528-1157.1994.tb02482.x
复制
发表时间：
1994-05-01
期刊：
影响因子：
5.6
通讯作者：
WILLIS, J
中科院分区：
文献类型：
--
作者：
BENMENACHEM, E;MANONESPAILLAT, R;WILLIS, J
在两项初步研究中，迷走神经刺激(VNS)被证明能减少难治性癫痫患者的发作频率。基于这些结果，启动了一项针对难治性部分性癫痫患者的多中心、前瞻性随机、平行、双盲研究。在12周的基准期后，植入相同的迷走神经刺激器，患者被随机分成高或低14周VNS治疗范例。主要目的是证明高VNS(治疗参数)比低VNS(治疗参数少或无效)在减少部分性发作频率方面更有效。患者继续接受抗癫痫药物(AEDs)治疗，血浆浓度在整个研究过程中保持不变。我们报告了首批退出14周急性期的67名患者的结果。治疗14周后，接受高VNS治疗的31例患者发作频率平均减少30.9%，与36例接受低VNS治疗的患者相比，平均发作频率百分比减少11.3%(p=0.029，t检验；p=0.036，Wilcoxon秩和检验)。与基线相比，除组内显著P值外，高VNS(p<；0.001)组的平均发作频率百分比变化达到统计学意义，而非低VNS(p=0.072)。接受高VNS治疗的31例患者中有12例(38.7%)在14周后发作频率至少减少了50%，而接受低VNS治疗的36例患者中有7例(19.4%)在14周后发作频率至少减少了50%。植入手术和VNS治疗耐受性良好。我们的研究证实了迷走神经刺激治疗癫痫难治性部分性发作的有效性。
Vagus nerve stimulation (VNS) was shown to reduce seizure frequency in refractory epilepsy patients in two pilot studies. Based on these results, a multicenter, prospectively randomized, parallel, double-blind study of patients with refractory partial seizures was initiated. After a 12-week baseline period, identical vagus nerve stimulators were implanted and patients randomized to either a high or low 14-week VNS treatment paradigm. The primary objective was to demonstrate that high VNS (therapeutic parameters) was more effective in reducing partial seizure frequency than was low VNS (less or noneffective parameters). Patients continued receiving antiepileptic drugs (AEDs) with plasma concentrations held constant throughout the study. We report results of the first 67 patients to exit the 14-week acute phase. After 14 weeks of VNS, 31 patients receiving high VNS experienced a mean seizure frequency percentage reduction of 30.9%, which was statistically significant as compared with the mean seizure frequency percentage reduction of 11.3% in 36 patients receiving low VNS (p = 0.029, t test; p = 0.036, Wilcoxon rank-sum test). In addition to the significant intragroup p-values, mean seizure frequency percentage change reached statistical significance for high VNS (p < 0.001) but not low VNS (p = 0.072) as compared with baseline. Twelve of 31 (38.7%) patients receiving high VNS achieved at least 50% reduction in seizure frequency whereas 7 of 36 (19.4%) patients receiving low VNS experienced at least 50% reduction after 14 weeks. The implant procedure and VNS therapy were well tolerated. Our study confirmed the effectiveness of VNS as treatment for epilepsy patients with refractory partial seizures.