迷走神经刺激治疗难治性癫痫:欧洲347例儿童24个月随访研究_Journal of Epilepsy

Authors：

OroszIren , McCormickDavid , ZamponiNelia , SophiaVaradkar , MarthaFeucht , ParainDominique , GriensRoger , ValleeLouis , BoonPaul , RitteyChristopher , K. JayewardeneAmara , BunkerMark , ArzimanoglouAlexis ,  LagaeLieven , 刘文钰 , 慕洁

Corresponding author：

LagaeLieven, Email: lieven.lagae@uzleuven.be

Keywords：

临床试验; 癫痫; 儿童; 生活质量; 迷走神经刺激术

DOI：

10.7507/2096-0247.20160081

Video：

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为了进一步探究迷走神经刺激术(Vagus nerve stimulation, VNS)在儿童难治性癫痫中的作用, 进行了连续随访达24个月, 系迄今最大样本量的多中心回顾性研究。主要目标是评估VNS术后癫痫主要发作类型(定义为最易致残的发作类型)的频率变化, 连续收集从基线开始一直到植入术后6、12及24个月的患者数据。统计人群包括347例患者(年龄6个月~17.9岁)。在植入后第6、12及24月, 分别有32.5%、37.6%及43.8%的患者主要发作类型的发作与基线相比, 有50%减少。亚组分析中, 在试验期间没有更换抗癫痫药物(AEDs)的患者有更好的反应。较好的结果也存在于所有次要指标, 包括癫痫发作持续时间、严重程度和发作后严重程度、生活质量、安全性等。多组分析表明VNS每天总放电量与反应效率有相关性。VNS治疗被认为是局灶性结构性癫痫患儿的附加治疗, 指那些经过两种及以上AEDs治疗后仍不适合外科手术的患者。全面性发作, 有遗传及结构异常的, 如Dravet综合征和Lennox-Gastaut综合征的患者能从VNS治疗中获益。结果表明随访24个月后, 难治性癫痫患儿通过附加的VNS治疗能够减少癫痫发作频率, 安全性良好; 多组分析表明VNS有剂量相关性。

Citation： OroszIren, McCormickDavid, ZamponiNelia, SophiaVaradkar, MarthaFeucht, ParainDominique, GriensRoger, ValleeLouis, BoonPaul, RitteyChristopher, K. JayewardeneAmara, BunkerMark, ArzimanoglouAlexis, LagaeLieven, 刘文钰, 慕洁. 迷走神经刺激治疗难治性癫痫:欧洲347例儿童24个月随访研究. Journal of Epilepsy, 2016, 2(5): 454-460. doi: 10.7507/2096-0247.20160081 Copy

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2.	Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med, 2000, 342(8):314-319.
3.	Kwan P, Arzimanoglou A, Berg AT, et al. Definition of drug resistant epilepsy:consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia, 2010, 51(7):1069-1077.
4.	Kwan P, Schachter SC, Brodie MJ. Drug-resistant epilepsy. N Engl J Med, 2011, 365(11):919-926.
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9.	Morris GL 3rd, Gloss D, Buchhalter J, et al. Evidence-based guideline update:vagus nerve stimulation for the treatment of epilepsy:report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology, 2013, 81(7):1453-1459.
10.	Hauptman JS, Mathern GW. Vagal nerve stimulation for pharmacoresistant epilepsy in children. Surg Neurol Int, 2012, 3(Suppl. 2):269-274.
11.	Elliott RE, Rodgers SD, Bassani L, et al. Vagus nerve stimulation for children with treatment-resistant epilepsy:a consecutive series of 141 cases. J Neurosurg Pediatr, 2011, 7(1):491-500.
12.	Arya R, Greiner HM, Lewis A, et al. Vagus nerve stimulation for medically refractory absence epilepsy. Seizure, 2013, 22(4):267-270.
13.	Thompson EM, Wozniak SE, Roberts CM, et al. Vagus nerve stimulation for partial and generalized epilepsy from infancy to adolescence. J Neurosurg Pediatr, 2012, 10(3):200-205.
14.	Helmers SL, Duh MS, Guerin A, et al. Clinical outcomes, quality of life, and costs associated with implantation of vagus nerve stimulation therapy in pediatric patients with drug-resistant epilepsy. Eur J Paediatr Neurol, 2012, 16(7):449-458.
15.	Reid SA. Surgical technique for implantation of the neurocybernetic prosthesis. Epilepsia, 1990, 31(Suppl. 2):38-39.
16.	Guy W. ECDEU assessment manual for psychopharmacology. Rockville, MD:US Department of Health, Education, and Welfare; 1976:1206-1225.
17.	Rosenbaum PR, Rubin DB. Reducing bias in observational studies using subclassification on the propensity score. J Am Stat Assoc, 1984, 79(1):516-524.
18.	Chhun S, Troude P, Villeneuve N, et al. A prospective open-labeled trial with levetiracetam in pediatric epilepsy syndromes:continuous spikes and waves during sleep is definitely a target. Seizure, 2011, 20(4):320-325.
19.	French JA, Krauss GL, Biton V, et al. Adjunctive perampanel for refractory partial-onset seizures:randomized Phase III Study 304. Neurology, 2012, 79(3):589-596.
20.	Gil-Nagel A, Elger C, Ben-Menachem E, et al. Efficacy and safety of eslicarbazepine acetate as add-on treatment in patients with focal-onset seizures:integrated analysis of pooled data from double-blind phase III clinical studies. Epilepsia, 2013, 54(2):98-107.
21.	Alexopoulos AV, Kotagal P, Loddenkemper T, et al. Long-term results with vagus nerve stimulation in children with pharmacoresistant epilepsy. Seizure, 2006, 15(4):491-503.
22.	Handforth A, DeGiorgio CM, Schachter SC, et al. Vagus nerve stimulation therapy for partial-onset seizures:a randomized active-control trial. Neurology, 1998, 51(4):48-55.
23.	Klinkenberg S, van den Bosch CN, Majoie HJ, et al. Behavioural and cognitive effects during vagus nerve stimulation in children with intractable epilepsy-a randomized controlled trial. Eur J Paediatr Neurol, 2013, 17(11):82-90.
24.	Patwardhan RV, Stong B, Bebin EM, et al. Efficacy of vagal nerve stimulation in children with medically refractory epilepsy. Neurosurgery, 2000, 47(7):1353-1357; discussion:1357-1358.
25.	The-VNS-Study-Group. The Vagus Nerve Stimulation Study Group. A randomized controlled trial of chronic vagus nerve stimulation for treatment of medically intractable seizures. Neurology, 1995, 45(7):224-230.
26.	Fisher RS, Handforth A. Reassessment:vagus nerve stimulation for epilepsy:a report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology, 1999, 53(8):666-669.
27.	Aaronson ST, Carpenter LL, Conway CR, et al. Vagus nerve stimulation therapy randomized to different amounts of electrical charge for treatment-resistant depression:acute and chronic effects. Brain Stimul, 2013, 6(1):631-640.

1. Berg AT, Zelko FA, Levy SR, et al. Age at onset of epilepsy, pharmacoresistance, and cognitive outcomes:a prospective cohort study. Neurology, 2012, 79(6):1384-1391.
2. Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med, 2000, 342(8):314-319.
3. Kwan P, Arzimanoglou A, Berg AT, et al. Definition of drug resistant epilepsy:consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia, 2010, 51(7):1069-1077.
4. Kwan P, Schachter SC, Brodie MJ. Drug-resistant epilepsy. N Engl J Med, 2011, 365(11):919-926.
5. Kwan P, Brodie MJ. Definition of refractory epilepsy:defining the indefinable?. Lancet Neurol, 2010, 9(6):27-29.
6. Elliott RE, Morsi A, Kalhorn SP, et al. Vagus nerve stimulation in 436 consecutive patients with treatment-resistant epilepsy:long-term outcomes and predictors of response. Epilepsy Behav, 2011, 20(8):57-63.
7. Morris GL, Mueller WM. Long-term treatment with vagus nerve stimulation in patients with refractory epilepsy. The Vagus Nerve Stimulation Study Group E01-E05. Neurology, 1999, 53(2):1731-1735.
8. Cukiert ACC, Burattini JA, Lima AM, et al. A prospective long-term study on the outcome after vagus nerve stimulation at maximally tolerated current intensity in a cohort of children with refractory secondary generalized epilepsy. Neuromodulation, 2012, 16(5):551-556.
9. Morris GL 3rd, Gloss D, Buchhalter J, et al. Evidence-based guideline update:vagus nerve stimulation for the treatment of epilepsy:report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology, 2013, 81(7):1453-1459.
10. Hauptman JS, Mathern GW. Vagal nerve stimulation for pharmacoresistant epilepsy in children. Surg Neurol Int, 2012, 3(Suppl. 2):269-274.
11. Elliott RE, Rodgers SD, Bassani L, et al. Vagus nerve stimulation for children with treatment-resistant epilepsy:a consecutive series of 141 cases. J Neurosurg Pediatr, 2011, 7(1):491-500.
12. Arya R, Greiner HM, Lewis A, et al. Vagus nerve stimulation for medically refractory absence epilepsy. Seizure, 2013, 22(4):267-270.
13. Thompson EM, Wozniak SE, Roberts CM, et al. Vagus nerve stimulation for partial and generalized epilepsy from infancy to adolescence. J Neurosurg Pediatr, 2012, 10(3):200-205.
14. Helmers SL, Duh MS, Guerin A, et al. Clinical outcomes, quality of life, and costs associated with implantation of vagus nerve stimulation therapy in pediatric patients with drug-resistant epilepsy. Eur J Paediatr Neurol, 2012, 16(7):449-458.
15. Reid SA. Surgical technique for implantation of the neurocybernetic prosthesis. Epilepsia, 1990, 31(Suppl. 2):38-39.
16. Guy W. ECDEU assessment manual for psychopharmacology. Rockville, MD:US Department of Health, Education, and Welfare; 1976:1206-1225.
17. Rosenbaum PR, Rubin DB. Reducing bias in observational studies using subclassification on the propensity score. J Am Stat Assoc, 1984, 79(1):516-524.
18. Chhun S, Troude P, Villeneuve N, et al. A prospective open-labeled trial with levetiracetam in pediatric epilepsy syndromes:continuous spikes and waves during sleep is definitely a target. Seizure, 2011, 20(4):320-325.
19. French JA, Krauss GL, Biton V, et al. Adjunctive perampanel for refractory partial-onset seizures:randomized Phase III Study 304. Neurology, 2012, 79(3):589-596.
20. Gil-Nagel A, Elger C, Ben-Menachem E, et al. Efficacy and safety of eslicarbazepine acetate as add-on treatment in patients with focal-onset seizures:integrated analysis of pooled data from double-blind phase III clinical studies. Epilepsia, 2013, 54(2):98-107.
21. Alexopoulos AV, Kotagal P, Loddenkemper T, et al. Long-term results with vagus nerve stimulation in children with pharmacoresistant epilepsy. Seizure, 2006, 15(4):491-503.
22. Handforth A, DeGiorgio CM, Schachter SC, et al. Vagus nerve stimulation therapy for partial-onset seizures:a randomized active-control trial. Neurology, 1998, 51(4):48-55.
23. Klinkenberg S, van den Bosch CN, Majoie HJ, et al. Behavioural and cognitive effects during vagus nerve stimulation in children with intractable epilepsy-a randomized controlled trial. Eur J Paediatr Neurol, 2013, 17(11):82-90.
24. Patwardhan RV, Stong B, Bebin EM, et al. Efficacy of vagal nerve stimulation in children with medically refractory epilepsy. Neurosurgery, 2000, 47(7):1353-1357; discussion:1357-1358.
25. The-VNS-Study-Group. The Vagus Nerve Stimulation Study Group. A randomized controlled trial of chronic vagus nerve stimulation for treatment of medically intractable seizures. Neurology, 1995, 45(7):224-230.
26. Fisher RS, Handforth A. Reassessment:vagus nerve stimulation for epilepsy:a report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology, 1999, 53(8):666-669.
27. Aaronson ST, Carpenter LL, Conway CR, et al. Vagus nerve stimulation therapy randomized to different amounts of electrical charge for treatment-resistant depression:acute and chronic effects. Brain Stimul, 2013, 6(1):631-640.

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