@article {DeGiorgio786作者={克里斯托弗·m·DeGiorgio和杰森·索斯和伊恩·a·库克和丹妮拉·马尔科维奇和杰弗里Gornbein和戴安娜穆雷和桑德拉·奥维耶多和史蒂芬·戈登和瓜达卢佩Corralle-Leyva和科林·p·Kealey厚颜克里斯蒂n见鬼},title ={三叉神经刺激的随机对照试验耐药性癫痫},体积={80}={9},页面= {786 - 791}= {2013},doi = {10.1212 / WNL。出版商0 b013e318285c11a} = {Wolters Kluwer健康,公司代表美国神经病学学会},文摘={目的:探讨外部刺激三叉神经的安全性和有效性(eTNS)耐药性癫痫患者(DR首页E)使用一个双盲随机对照试验设计和试验的治疗和控制参数的适用性为三期多中心临床试验做准备。方法:这是一个双盲随机主动控制试验DRE。五十每月科目和2个或更多的部分性发作(复杂的部分或tonic-clonic)为期6个月的进入了一个基线时期中,然后评估在6、12日和18周期间急性治疗期。受试者被随机分配到治疗(eTNS 120 Hz)或控制(eTNS 2 Hz)参数。结果:在条目,受试者高度耐药,平均每月8.7癫痫(治疗组)和4.8每月发作(主动控制)。平均而言,受试者没有3.35抗癫痫药物在入学之前,癫痫的平均持续时间为21.5年(治疗组)和23.7年(主动控制集团),分别。eTNS耐受良好。副作用包括焦虑(4 \ %),头痛(4 \ %),和皮肤过敏(14 \ %)。应答率,定义为\ > 50 \ %减少发作频率,是治疗组21.1 vs 30.2 \ % \ %为主动控制集团18-week治疗期(不显著,p = 0.31,广义估计方程(GEE)模型)。治疗组经历了一个显著的类内提高应答率18-week治疗期间(从17.8 \ % 40.5 6周\ %在18周,p = 0.01,哇)。 Subjects in the treatment group were more likely to respond than patients randomized to control (odds ratio 1.73, confidence interval 0.59{\textendash}0.51). eTNS was associated with reductions in seizure frequency as measured by the response ratio (p = 0.04, analysis of variance [ANOVA]), and improvements in mood on the Beck Depression Inventory (p = 0.02, ANOVA).Conclusions: This study provides preliminary evidence that eTNS is safe and may be effective in subjects with DRE. Side effects were primarily limited to anxiety, headache, and skin irritation. These results will serve as a basis to inform and power a larger multicenter phase III clinical trial.Classification of evidence: This phase II study provides Class II evidence that trigeminal nerve stimulation may be safe and effective in reducing seizures in people with DRE.AED=antiepileptic drug; ANOVA=analysis of variance; BDI=Beck Depression Inventory; DRE=drug-resistant epilepsy; eTNS=external trigeminal nerve stimulation; GEE=generalized estimating equation; GTC=generalized tonic-clonic seizure; HR=heart rate; IRB=institutional review board; OR=odds ratio; TNS=trigeminal nerve stimulation; VNS=vagus nerve stimulation}, issn = {0028-3878}, URL = {//www.ez-admanager.com/content/80/9/786}, eprint = {//www.ez-admanager.com/content/80/9/786.full.pdf}, journal = {Neurology} }