目的：本研究旨在探讨经皮（耳甲腔）电刺激耳迷走神经（ta-VNS）可否作为治疗难治性癫痫的一种有效方法。方法：采用经皮神经电刺激双盲法。首先，对50 名难治性癫痫患者进行经皮电刺激耳迷走神经治疗（ta-VNS），初步观察治疗效果。然后，将另外144 名癫痫患者随机分为：经皮电刺激耳迷走神经组（ta-VNS，n=98）和经皮电刺激非耳迷走神经组（tn-VNS，n =46）。每日治疗两次，共治疗24 周。除了ta-VNS 和tn-VNS 组患者以外，其余同期入院患者均接受药物治疗。以校准恩格尔分级标准为疗效观察指标。在治疗后的第8 周、第16 周和第24 周，对癫痫发作频率和严重程度进行评估。结果：前期研究中的50例癫痫患者，经过8 周治疗后，6 例无癫痫发作，12 例发作频率分别减少了50%~89%。经过24 周治疗后，8例无癫痫发作，2 例癫痫发作频率减少≥90%，9 例发作频率分别减少了50%~89%。在144 例癫痫患者的研究中，经过8 周治疗后，ta-VNS 组的98 例患者中10 例无癫痫发作，6 例发作频率减少≥90%，25 例发作频率减少了50%~89%。经过24 周的治疗后，15 例无癫痫发作，6 例发作频率减少≥90%，26 例减少了50%~89%。经过前8 周的治疗，tn-VNS 对照组的46 例患者重只有3 例无癫痫发作，2 例患者减少90%以上，9 例发作频率减少了50%~89%。经过额外16 周的ta-VNS 治疗后，46 例患者中有7 例无癫痫发作，14例发作频率减少50%~89%。各组间发作频率减少百分比差异显著（P<0.05）。结论：ta-VNS 与VNS 作用相类似，能够抑制癫痫发作，是一个安全、有效、经济且广泛适用的治疗难治性癫痫方法。

This study was aimed to examine whether transcutaneous auricular vagus nerve electrical stimulation (ta-VNS) at auricular concha area was an effective approach for patients with refractory seizures. Double-blind transcutaneous nerve electrical stimulation was applied in this study. A pilot study was conducted firstly on 50 patients with refractory seizures to preliminarily observe the therapeutic effect of ta-VNS. Then, a randomized controlled trial(RCT) was conducted on another 144 epilepsy patients who were randomly assigned to the ta-VNS group (n = 98),and the transcutaneous non-auricular vagus nerve electrical stimulation (tn-VNS) control group (n = 46). The treatment was performed twice a day for 24 weeks. Patients who were neither in the ta-VNS group nor the tn-VNS group accepted medication at the same time. The seizure frequency and severity were assessed in the 8-week, 16-week and 24-week of the treatment according to the modified Engel scale. The results showed that in the pilot study, after 8-week treatment, 6 out of 50 epilepsy patients were seizure free; and 12 cases had a 50%-89% reduction in seizure frequency. After 24-week treatment, 8 cases were seizure free; 2 cases had a more than 90% reduction in seizure frequency; and 9 cases had a 50%-89% reduction in seizure frequency. In the RCT study of 144 epilepsy patients, after 8-week treatment, 10 out of 98 patients in the ta-VNS group were seizure free; 6 cases had a more than 90% reduction in seizure frequency; and 25 cases had a 50%-89% reduction in seizure frequency. After 24-week treatment, 15 cases were seizure free; 6 cases had a more than 90% reduction in seizure frequency; and 26 cases had a 50%-89% reduction in seizure frequency. After 8-week treatment, in the tn-VNS control group, only 3 out of 46 patients were seizure free; 2 cases had a more than 90% reduction in seizure frequency; and 9 cases had a 50%-89% reduction in seizure frequency. After an additional 16-week treatment of ta-VNS, 7 out of 46 patients were seizure free; 14 had a 50%-89% reduction in seizure frequency. There were significant differences in seizure frequency reduction among groups (P < 0.05). It was concluded that ta-VNS, which had similar therapeutic effect as VNS, was able to suppress epileptic seizures. It is a safe, effective, economic, and applicable treatment option for the treatment of refractory epilepsy.

科学技术部国家重点基础研究发展计划（“973”计划）（2011CB505200-01）：针刺对功能性肠病的双向调节效应及其机制，负责人：朱兵；科学技术部国家重点基础研究发展计划（“973”计划）（2012CB518503）：经穴效应循经特异性靶器官响应的生物学基础研究，负责人：荣培晶；国家自然科学基金委面上项目（C30973798）：耳针抗癫痫效应与耳甲-迷走神经联系，负责人：荣培晶；北京市卫生局首都医学发展科研基金（中医药类）（TCMSF-2009-Ⅱ-15）：耳针经皮电刺激治疗难治性癫痫的应用研究，负责人：刘爱华；科学技术部国家科技支撑“十二五”计划项目（2012BAF14B10）：外配式经耳穴迷走神经剌激仪的研发，负责人：荣培晶。