Neurology. 1995 Feb;45(2):224-30. doi: 10.1212/wnl.45.2.224.
Preliminary reports have suggested that chronic, intermittent stimulation of the vagus nerve (VNS) is an alternative treatment for patients with medically refractory seizures. We performed a multicenter, randomized, controlled trial to evaluate the efficacy and safety of adjunctive VNS in patients with poorly controlled partial seizures. An implanted, programmable pacemaker-like device was connected to two stimulating electrodes wrapped around the left vagus nerve. One hundred fourteen patients were randomized to receive 14 weeks of high-level stimulation (presumed therapeutic dose) or low-level stimulation (presumed subtherapeutic dose) using a blinded, parallel study design. Seizure frequency was compared with a 12-week baseline. Mean reduction in seizure frequency was 24.5% for the "high" stimulation group versus 6.1% for the "low" stimulation group (p = 0.01). Thirty-one percent of patients receiving high stimulation had a seizure frequency reduction of > or = 50%, versus 13% of patients in the low group (p = 0.02). Treatment emergent side effects were largely limited to a transient hoarseness occurring during the stimulation train. One patient with no previous history of cardiac disease experienced a myocardial infarction during the third month of vagal stimulation. VNS may be an effective alternative treatment for patients who have failed antiepileptic drug therapy and are not optimal candidates for epilepsy surgery.
初步报告表明，慢性间歇性刺激迷走神经（VNS）是药物难治性癫痫患者的一种替代治疗方法。我们进行了一项多中心、随机、对照试验，以评估辅助VNS治疗部分性癫痫控制不佳患者的疗效和安全性。一个植入式、可编程的类似起搏器的装置与缠绕在左迷走神经上的两个刺激电极相连。114名患者采用双盲、平行研究设计，随机接受14周的高强度刺激（假定为治疗剂量）或低强度刺激（假定为亚治疗剂量）。将癫痫发作频率与12周的基线进行比较。“高”刺激组癫痫发作频率平均降低24.5%，而“低”刺激组为6.1%（p = 0.01）。接受高刺激的患者中有31%癫痫发作频率降低≥50%，而低刺激组为13%（p = 0.02）。治疗出现的副作用主要局限于刺激过程中出现的短暂性声音嘶哑。一名既往无心脏病史的患者在迷走神经刺激的第三个月发生了心肌梗死。对于抗癫痫药物治疗失败且不是癫痫手术最佳候选者的患者，VNS可能是一种有效的替代治疗方法。
