经皮耳迷走神经刺激治疗难治性癫痫的临床试验研究  

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Refractory Epileptic Seizures

作　　者：荣培晶[1] 刘爱华[2] 张建国 王玉平[2] 杨岸超 贲卉[1] 李亮[1] 李丽萍[2] 宋潞 刘焕光 何伟[1] 黄凤[1] 李霞[1] 刘儒鹏[1] 吴鹏[1] 朱兵[1] 

机构地区：[1]中国中医科学院针灸研究所,北京100700 [2]首都医科大学附属宣武医院神经内科,北京100053 [3]天坛医院神经外科研究所,北京100050

出　　处：《世界科学技术-中医药现代化》2013年第9期2011-2020,共10页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：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)(TCM-SF-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

摘　　要：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 transcu- taneous 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 treat- ment 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 26cases 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

关 键 词：难治性癫痫 迷走神经刺激 耳迷走神经分支 经耳甲腔刺激迷走神经 

分 类 号：R742.1[医药卫生—神经病学与精神病学]