Department of Neurosurgery, New York University Langone Medical Center, New York, NY
Epilepsy Behav. 2011 Jan;20(1):57-63. doi: 10.1016/j.yebeh.2010.10.017. Epub 2010 Dec 8.
The goal of this study was to assess the efficacy and safety of vagus nerve stimulation in a consecutive series of adults and children with treatment-resistant epilepsy (TRE).
In this retrospective review of a prospectively created database of 436 consecutive patients who underwent vagus nerve stimulator implantation for TRE between November 1997 and April 2008, there were 220 (50.5%) females and 216 (49.5%) males ranging in age from 1 to 76 years at the time of implantation (mean: 29.0 ± 16.5). Thirty-three patients (7.6%) in the primary implantation group had inadequate follow-up (<3 months from implantation) and three patients had early device removal because of infection and were excluded from seizure control outcome analyses.
Duration of vagus nerve stimulation treatment varied from 10 days to 11 years (mean: 4.94 years). Mean seizure frequency significantly improved following implantation (mean reduction: 55.8%, P<0.0001). Seizure control ≥ 90% was achieved in 90 patients (22.5%), ≥ 75% seizure control in 162 patients (40.5%), ≥ 50% improvement in 255 patients (63.75%), and <50% improvement in 145 patients (36.25%). Permanent injury to the vagus nerve occurred in 2.8% of patients.
Vagus nerve stimulation is a safe and effective palliative treatment option for focal and generalized TRE in adults and children. When used in conjunction with a multidisciplinary and multimodality treatment regimen including aggressive antiepileptic drug regimens and epilepsy surgery when appropriate, more than 60% of patients with TRE experienced at least a 50% reduction in seizure burden. Good results were seen in patients with non-U.S. Food and Drug Administration-approved indications. Prospective, randomized trials are needed for patients with generalized epilepsies and for younger children to potentially expand the number of patients who may benefit from this palliative treatment.
本研究旨在评估迷走神经刺激在一系列成人和儿童耐药性癫痫（TRE）患者中的疗效和安全性。
在这项对 1997 年 11 月至 2008 年 4 月期间因 TRE 接受迷走神经刺激器植入的 436 例连续患者的前瞻性创建数据库的回顾性研究中，有 220 例（50.5%）为女性，216 例（49.5%）为男性，植入时年龄为 1 至 76 岁（平均：29.0 ± 16.5）。在原发性植入组中，有 33 例患者（7.6%）随访不足（植入后<3 个月），有 3 例患者因感染早期移除设备，故排除在癫痫发作控制结果分析之外。
迷走神经刺激治疗的时间从 10 天到 11 年不等（平均：4.94 年）。植入后癫痫发作频率显著改善（平均减少：55.8%，P<0.0001）。90 例患者（22.5%）达到≥90%的癫痫发作控制，162 例患者（40.5%）达到≥75%的癫痫发作控制，255 例患者（63.75%）癫痫发作改善≥50%，145 例患者（36.25%）癫痫发作改善<50%。迷走神经永久性损伤发生率为 2.8%。
迷走神经刺激是成人和儿童局灶性和全身性 TRE 的一种安全有效的姑息治疗选择。当与多学科、多模式治疗方案联合使用时，包括积极的抗癫痫药物治疗方案和适当的癫痫手术，超过 60%的 TRE 患者的癫痫发作负担至少减少 50%。非美国食品和药物管理局批准的适应证患者也取得了良好的效果。需要进行前瞻性、随机试验，以确定全身性癫痫和年龄较小的儿童患者是否可能从这种姑息治疗中获益。
