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1 2013 绎 Vol.15 No.9 1 援 ta-vns 50 ta-vns 144 ta-vns n=98 tn-vns n =46 24 ta-vns tn-vns 豫 ~89 豫逸 90 豫 9 50 豫 ~89 豫 ta-vns 逸 90 豫豫 ~89 豫逸 90 豫豫 ~89 豫 8 tn-vns 豫 9 50 豫 ~89 豫 16 ta-vns 豫 ~89 豫 P<0.05 ta-vns VNS doi: /wst R742.1 A 1 [1] 0.7 豫 900 [2] [3] 元 CB CB C TCM- SF 域 BAF14B10 元元元元元 2011

2 绎 Vagusnervestimula 原 tion VNS [4] 1997 Food and Drug Admistraton FDA 12 [5] [6] Nucle 原 us Tractus Solitarius NTS [7] Auricular Branchofvagus Nerve ABVN Alderman's Arnold's ABVN NTS - NTS [8 9] ta -VNS VNS EEG, ChiCTR -TRC 依豫豫豫豫豫豫 1 ta-vns tn-vns ta-vns tn-vns / / / / 50 / (30/20) 依依 8.19 (18 ) ( 9 ) (14 ) (2 ) (7 ) ta-vns 98 / (64/34) 依依 9.05 (35 ) 24 (16 ) (13 ) (5 ) (4 ) (1 ) tn-vns 46 / (29/17) 依依 (19 ) (8 ) (13 ) (2 ) (3 ) (1 ) 2012

3 2013 绎 Vol.15 No.9 2 / / ta-vns 依依依 tn-vns 依依依 P AEDs / IRB MRI [10] 4 玉域逸 90 豫芋 50%~89 豫郁 <50 豫 ta - VNS 30 / 颐 1 ta-vns n=98 tn-vns n= ta-vns 24 ta-vns tn-vns 8 tn-vns 16 ta-vns ta-vns tn-vns TENSsm TENS ta-vns tn-vns ta-vns tn-vns

绎 120 TENS ta-vns tn-vns 1mA 20~30Hz 臆 1 ms 4 TENS TENS 8 16 24 4 [10] 8 EEG ta-vns

4 绎 120 TENS ta-vns tn-vns 1mA 20~30Hz 臆 1 ms 4 TENS TENS [10] 8 EEG ta-vns tn-vns ta-vns QOL [11] 2.6 SPSS 15.0 SPSS IL USA 依 x 依 SE ta-vns tn-vns Wilcoxon P< 豫 24 ta-vns ta-vns 豫 I 豫 50 豫 ~89 豫 III 豫郁豫 I 2 4 豫逸 90 豫域豫 ~89 豫豫豫 3 ta-vns

2013 绎 Vol.15 No.9 芋 24 10 20 豫 ta-vns 8 16 24 P<0.05 ta- VNS 8 16 24 27 P<0.05 3.2 2001 144 11 7.6 豫 3 ta-vns 8 ta-vns 98 41 41.84 豫 10 10.20 豫 I 6 6.12 豫逸 90 豫 II 25 25.51 豫 50 豫 ~89 豫芋 57 58.

5 2013 绎 Vol.15 No.9 芋豫 ta-vns P<0.05 ta- VNS P< 豫 3 ta-vns 8 ta-vns 豫豫 I 豫逸 90 豫 II 豫 50 豫 ~89 豫芋豫约 50 豫郁豫 47/ 豫 I 豫逸 90 豫 II 豫 50%~89 豫芋 3 4 ta-vns P<0.05 P< tn-vns 豫 I 豫 90 豫 II 豫 50~89 豫芋 ta- VNS tn -VNS P 约 3 ta-vns tn-vns ta-vns n=98 (%) tn-vns n=46 (%) 玉 10(10.20) 13(13.27) 15(15.31) 3(6.52) 5(13.51) 7(18.92) 域逸 90% 6(6.12) 6(6.12) 6(6.12) 2(4.35) 1(2.70) 0(0.00) 芋 50-90% 25(25.51) 31(31.63) 26(26.53) 9(19.57) 15(40.54) 14(37.84) 郁 : 约 50% 57(58.16) 48(48.98) 51(52.04) 32(69.57) 17(43.24) 17(43.24) 4 ta-vns 8 5 ta-vns 绎绎绎 P<0.05 P<

绎 0.05 6 46 8 tn-vns ta-vns, 16 8 ta-vns 46 5 13.51 豫 15 40.54 豫 90 豫 50 豫 ~89 豫 16 ta-vns 46 7 18.92 豫 14 37.84 豫 50 豫 ~89 豫 8 16 ta-vns 8 tn- VNS P<0.

3 178 141 ta-vns 37 tn-vns Electroencephalo 原 gram EEG ta-vns 玉 - 芋 ta-vns 8A ta-vns Spike Foci ta-vns 24 1 II 8B 3.4 ta-vns 98 85 (86.74%) 61 (62.

6 绎 tn-vns ta-vns, 16 8 ta-vns 豫豫 90 豫 50 豫 ~89 豫 16 ta-vns 豫豫 50 豫 ~89 豫 8 16 ta-vns 8 tn- VNS P<0.05 P< tn-vns 8 8 ta-vns 豫 tn-vns 豫 P< ta-vns 37 tn-vns Electroencephalo 原 gram EEG ta-vns 玉 - 芋 ta-vns 8A ta-vns Spike Foci ta-vns 24 1 II 8B 3.4 ta-vns (86.74%) 61 (62.25%) 83 tn-vns 16 ta- VNS 31% 豫豫豫 10~ 绎绎绎 tn-vns 8 P<0.05 P<0.01 ta-vns 0 ** P 约 0.01 *** P 约 ta-vns tn-vns # P 约 VNS VNS 50 豫 VNS 40 豫 ~50 豫 50 豫 [10 12~16] [17] 75 豫 VNS 29.0 豫 [18] VNS 2016

7 2013 绎 Vol.15 No ta-vns ta-vns 8 II 2017

8 绎 [19] 10 [20] ta-vns tn-vns 8 ta-vns tn-vns 16 ta-vns NTS - ta-vns VNS [21~24] FDA VNS [25] F-18 Positron Emission Tomography PET 31 [26] fos- VNS VNS [27] ta-vns ta-vns 8 tn-vns 5 ta-vns VNS - 1 Fisher R S, van Emde Boas W, Blume W, et al. Epileptic seizures and epilepsy: definitions proposed by the International League Against Epilepsy (ILAE) and the International Bureau for Epilepsy (IBE). Epilepsia, 2005, 46(4) 颐 470~ Wang W Z, Wu J Z, Wang D S, et al. The prevalence and treatment gap in epilepsy in China: an ILAE/IBE/WHO study. Neurology, 2003, 60(9) 颐 1544~ Van Ness P C. Therapy for the epilepsies. Arch Neurol, 2002, 59 (5) 颐 732~ Lanska D J. J.L. Corning and vagal nerve stimulation for seizures in the 1880s. Neurology, 2002, 58(3) 颐 452~ Helmers S L, Duh M S, Guerin A, et al. Clinical and economic impact of vagus nerve stimulation therapy in patients with drug - resistant epilepsy. Epilepsy Behav, 2011, 22(2) 颐 370~ Cohen -Gadol A A, Britton J W, Wetjen N M, et al. Neurostimulation therapy for epilepsy: current modalities and future directions. Mayo Clin Proc, 2003, 78(2) 颐 238~ Magdaleno -Madrigal V M, Martinez -Vargas D, Valdes -Cruz A, et al. Preemptive effect of nucleus of the solitary tract stimulation on amygdaloid kindling in freely moving cats. Epilepsia, 2010, 51(3) 颐 438~ Yang A C, Zhang J G, Rong P J, et al. A new choice for the treatment of epilepsy: electrical auricula -vagus -stimulation. Med Hypotheses, 2011, 77(2) 颐 244~ He W, Rong P J, Li L, Ben H, et al. Auricular Acupuncture May Suppress Epileptic Seizures via Activating the Parasympathetic Nervous System: A Hypothesis Based on Innovative Methods. Evid Based Complement Alternat Med, 2012, 2012 颐 Elliott R E, Morsi A, Tanweer O, et al. Efficacy of vagus nerve stimulation over time: review of 65 consecutive patients with treatment -resistant epilepsy treated with VNS > 10 years. Epilepsy Behav, 2011, 20(3) 颐 478~ Alexopoulos A V, Kotagal P, Loddenkemper T, et al. Long-term results with vagus nerve stimulation in children with pharmacoresistant epilepsy. Seizure, 2006, 15(7) 颐 491~ Ben-Menachem E, Manon-Espaillat R, Ristanovic R, et al. Vagus nerve stimulation for treatment of partial seizures: 1. A controlled study of effect on seizures. First International Vagus Nerve Stimulation Study Group. Epilepsia, 1994, 35(3) 颐 616~ Morris G L 3rd, Mueller W M. Long -term treatment with vagus nerve stimulation in patients with refractory epilepsy. The Vagus Nerve Stimulation Study Group E01-E05. Neurology, 1999, 53(8) 颐 1731~ Handforth A, DeGiorgio C M, Schachter S C, et al. Vagus nerve 2018

9 2013 绎 Vol.15 No.9 stimulation therapy for partial -onset seizures: a randomized active - control trial. Neurology, 1998, 51(1) 颐 48~ Wheeler M, De Herdt V, Vonck K, et al. Efficacy of vagus nerve stimulation for refractory epilepsy among patient subgroups: a re - analysis using the Engel classification. Seizure, 2011, 20(4) 颐 331~ Elliott R E, Morsi A, Kalhorn S P, et al. Vagus nerve stimulation in 436 consecutive patients with treatment-resistant epilepsy: longterm outcomes and predictors of response. Epilepsy Behav, 2011, 20(1) 颐 57~ McHugh J C, Singh H W, Phillips J, et al. Outcome measurement after vagal nerve stimulation therapy: proposal of a new classification. Epilepsia, 2007, 48(2) 颐 375~ Witt C, Brinkhaus B, Jena S, et al. Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet, 2005, 366 (9480) 颐 136~ Guberman A. Vagus nerve stimulation in the treatment of epilepsy. CMAJ, 2004, 171(10) 颐 1165~ Valencia I, Holder D L, Helmers S L, et al. Vagus nerve stimulation in pediatric epilepsy: a review. Pediatr Neurol, 2001, 25(5) 颐 368~ Janszky J, Hoppe M, Behne F, et al. Vagus nerve stimulation: predictors of seizure freedom. J Neurol Neurosurg Psychiatry, 2005, 76(3) 颐 384~ Shahwan A, Bailey C, Maxiner W, et al. Vagus nerve stimulation for refractory epilepsy in children: More to VNS than seizure frequency reduction. Epilepsia, 2009, 50(5) 颐 1220~ Tanganelli P, Ferrero S, Colotto P, et al. Vagus nerve stimulation for treatment of medically intractable seizures. Evaluation of long - term outcome. Clin Neurol Neurosurg, 2002, 105(1) 颐 9~ Stefan H, Kreiselmeyer G, Kerling F, et al. Transcutaneous vagus nerve stimulation (t-vns) in pharmacoresistant epilepsies: A proof of concept trial. Epilepsia, 2012, 53(7) 颐 e115~e Henry T R. Therapeutic mechanisms of vagus nerve stimulation. Neurology, 2002, 59(6 Suppl 4) 颐 S3~S Petrucci M, Hoh C, Alksne J F. Thalamic hypometabolism in a patient undergoing vagal nerve stimulation seen on F-18 FDG PET imaging. Clin Nucl Med, 2003, 28(9) 颐 784~ Naritoku D K, Terry W J, Helfert R H. Regional induction of fos immunoreactivity in the brain by anticonvulsant stimulation of the vagus nerve. Epilepsy Res, 1995, 22(1) 颐 53~62. Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Refractory Epileptic Seizures Rong Peijing 1,LiuAihua 2, Zhang Jianguo 3,WangYuping 2, Yang Anchao 3,BenHui 1,LiLiang 1,LiLiping 2, Song Lu 2, Liu Huanguang 3,HeWei 3, Huang Feng 1,LiXia 1,LiuRupeng 1,WuPeng 1, Zhu Bing 1 (1. Institute of A cupuncture-moxibustion, China A cademy of Chinese Medical Sciences, Beijing , China; 2. Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing , China; 3. Institute of Neurosurgery, Tiantan Hospital, Beijing , China) Abstract: 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 鄄 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 鄄 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

10 绎 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. Keywords: Refractory epilepsy, vagus nerve stimulation, auricular branch of the vagus nerve, auricular vagus nerve stimulation at auricular concha area 2020

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