Ramsay R E, Uthman B M, Augustinsson L E, Upton A R, Naritoku D, Willis J, Treig T, Barolat G, Wernicke J F
Veterans Administration Hospital, Miami, Florida.
Epilepsia. 1994 May-Jun;35(3):627-36. doi: 10.1111/j.1528-1157.1994.tb02483.x.
Vagus nerve stimulation (VNS) significantly reduces the frequency of partial seizures in refractory epilepsy patients. We examined the serious adverse events, side effects, and tolerability as they relate to the surgical implant procedure and the stimulating device. We also reviewed potential drug interactions, device output complications, and impact of the therapy on overall health status. We analyzed the first 67 patients to exist the acute phase of the EO3 VNS trial comparing high (therapeutic) VNS to low (less or noneffective) VNS. Data were collected from case report forms used at each of the four visits during the 12-week baseline and at each of the four visits during the 14-week randomized phase of the trial. No significant complications were reported as a result of the implant procedure. Serious adverse events included 1 patient who experienced direct current to the vagus nerve owing to generator malfunction resulting in left vocal cord paralysis and withdrawal of the patient from the study. No clinically significant effects on vital signs, cardiac function, or gastric function were detected. Side effects associated with VNS in the high group were hoarseness (35.5%), coughing (13.9%), and throat pain (12.9%). In the low group, only hoarseness (13.9%) and throat pain (13.9%) were associated with VNS. These effects generally wrre not considered clinically significant and occurred primarily during the stimulation pulses. No patients discontinued VNS therapy during the acute phase because of side effects associated with normal stimulation. Except for the one instance of a short circuit in the system resulting in a direct current, stimulating system complications were minor, limited to programming, unscheduled stimulation, and high lead impedance. Patients, investigators, and patient companions rated patients receiving high stimulation as more "improved" than those receiving low stimulation in regards to overall health status. Antiepileptic drug (AED) plasma concentrations were not affected by VNS. The implant procedure, stimulating system, and therapy proved safe and tolerable during the study. The high percentage (67 of 68) of patients completing the study reflects patient acceptance and tolerability of this mode of therapy.
迷走神经刺激（VNS）可显著降低难治性癫痫患者部分性癫痫发作的频率。我们研究了与手术植入过程和刺激装置相关的严重不良事件、副作用及耐受性。我们还回顾了潜在的药物相互作用、装置输出并发症以及该疗法对整体健康状况的影响。我们分析了EO3 VNS试验急性期的首批67例患者，比较了高（治疗性）VNS与低（较少或无效）VNS。数据收集自试验12周基线期的四次访视以及14周随机阶段的四次访视所使用的病例报告表。未报告因植入过程导致的显著并发症。严重不良事件包括1例因发生器故障致使迷走神经受到直流电刺激，进而导致左侧声带麻痹，该患者退出研究。未检测到对生命体征、心脏功能或胃功能有临床显著影响。高剂量组与VNS相关的副作用有声音嘶哑（35.5%）、咳嗽（13.9%）和咽痛（12.9%）。低剂量组中，仅声音嘶哑（13.9%）和咽痛（13.9%）与VNS相关。这些影响通常不被认为具有临床显著性，且主要发生在刺激脉冲期间。急性期无患者因与正常刺激相关的副作用而停止VNS治疗。除系统出现一次短路导致直流电刺激的情况外，刺激系统并发症轻微，仅限于编程、非计划刺激和高导联阻抗。在整体健康状况方面，患者、研究者及患者同伴认为接受高剂量刺激的患者比接受低剂量刺激的患者“改善”程度更高。抗癫痫药物（AED）的血浆浓度不受VNS影响。在研究期间，植入过程、刺激系统及疗法被证明是安全且可耐受的。高比例（68例中的67例）患者完成研究反映了患者对这种治疗方式的接受度和耐受性。
