Handforth A, DeGiorgio C M, Schachter S C, Uthman B M, Naritoku D K, Tecoma E S, Henry T R, Collins S D, Vaughn B V, Gilmartin R C, Labar D R, Morris G L, Salinsky M C, Osorio I, Ristanovic R K, Labiner D M, Jones J C, Murphy J V, Ney G C, Wheless J W
West Los Angeles VA Medical Center, Los Angeles, CA 90073, USA.
Neurology. 1998 Jul;51(1):48-55. doi: 10.1212/wnl.51.1.48.
The purpose of this multicenter, add-on, double-blind, randomized, active-control study was to compare the efficacy and safety of presumably therapeutic (high) vagus nerve stimulation with less (low) stimulation.
Chronic intermittent left vagus nerve stimulation has been shown in animal models and in preliminary clinical trials to suppress the occurrence of seizures.
Patients had at least six partial-onset seizures over 30 days involving complex partial or secondarily generalized seizures. Concurrent antiepileptic drugs were unaltered. After a 3-month baseline, patients were surgically implanted with stimulating leads coiled around the left vagus nerve and connected to an infraclavicular subcutaneous programmable pacemaker-like generator. After randomization, device initiation, and a 2-week ramp-up period, patients were assessed for seizure counts and safety over 3 months. The primary efficacy variable was the percentage change in total seizure frequency compared with baseline.
Patients receiving high stimulation (94 patients, ages 13 to 54 years) had an average 28% reduction in total seizure frequency compared with a 15% reduction in the low stimulation group (102 patients, ages 15 to 60 year; p = 0.04). The high-stimulation group also had greater improvements on global evaluation scores, as rated by a blinded interviewer and the patient. High stimulation was associated with more voice alteration and dyspnea. No changes in physiologic indicators of gastric, cardiac, or pulmonary functions occurred.
Vagus nerve stimulation is an effective and safe adjunctive treatment for patients with refractory partial-onset seizures. It represents the advent of a new, nonpharmacologic treatment for epilepsy.
本多中心、附加、双盲、随机、活性对照研究的目的是比较推测具有治疗作用的（高）迷走神经刺激与较少（低）刺激的疗效和安全性。
慢性间歇性左迷走神经刺激在动物模型和初步临床试验中已显示可抑制癫痫发作的发生。
患者在30天内至少有6次部分性发作，包括复杂部分性发作或继发性全身性发作。同时使用的抗癫痫药物不变。经过3个月的基线期后，患者通过手术植入缠绕在左迷走神经周围的刺激电极，并连接到锁骨下皮下可编程起搏器样发生器。随机分组、启动装置并经过2周的剂量递增期后，对患者进行3个月的癫痫发作计数和安全性评估。主要疗效变量是与基线相比总癫痫发作频率的百分比变化。
接受高刺激的患者（94例，年龄13至54岁）总癫痫发作频率平均降低28%，而低刺激组（102例，年龄15至60岁）降低15%（p = 0.04）。高刺激组在由盲法访谈者和患者评定的整体评估分数上也有更大改善。高刺激与更多的声音改变和呼吸困难相关。胃、心脏或肺功能的生理指标未发生变化。
迷走神经刺激对难治性部分性发作患者是一种有效且安全的辅助治疗方法。它代表了一种新的非药物癫痫治疗方法的出现。
