拉科酰胺在癫痫持续状态中的应用　　—针对现有证据的系统评价_Journal of Epilepsy

Authors：

 AdamStrzelczyk , JohannPhilipp Zollner , LaurentM Willems , 肖英凤　译 , 童馨　慕洁　审

Corresponding author：

AdamStrzelczyk, Email: strzelczyk@med.uni-frankfurt.de

Keywords：

拉科酰胺; 癫痫持续状态; 痫性发作; 癫痫; 电压门控钠通道

DOI：

10.7507/2096-0247.20180073

Video：

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Abstract Full text Figures/Tables Video References Cited by

拉科酰胺（Lacosamide，LCM）的静脉制剂具有良好的耐受性和安全性，促使其在癫痫持续状态（Status Epilepticus，SE）中得到应用。本项系统评价的目的是确定和评估 LCM 在 SE 中的使用情况。在电子数据库中用联合检索方式对 2008 年—2016 年 10 月的文献进行了系统检索，并使用标准化的评估表格从各项研究中将有关研究设计、方法框架、数据源、有效性和 LCM 引起的不良反应的信息进行提取并系统地报告。研究共评估了 522 次 SE 发作，其中包括 486 例成人和 36 例儿童及青少年发作，女性占 51.7%。LCM 的总体效力为 57%。LCM 对非惊厥性（57%，82/145）和全面痉挛性（61%，30/49，P=0.68）SE 的效力相似，但对局灶运动性 SE 的总体有效率更高（92%，34/39，P<0.001）。而 LCM 在用药次序靠后时其疗效从 100%下降到 20%。治疗期间的主要不良反应是眩晕，视力异常，复视和共济失调。总体而言，LCM 具有良好的耐受性，并且没有具临床意义的药物相互作用。现有数据表明 LCM 在 SE 中的使用是有前景的，有效率为 57%。LCM 的优势在于没有潜在的药物相互作用，并且在紧急情况需迅速增加剂量时可静脉使用。

Citation： AdamStrzelczyk, JohannPhilipp Zollner, LaurentM Willems, 肖英凤　译, 童馨　慕洁　审. 拉科酰胺在癫痫持续状态中的应用　　—针对现有证据的系统评价. Journal of Epilepsy, 2018, 4(5): 446-460. doi: 10.7507/2096-0247.20180073 Copy

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1. Kortland LM, Alfter A, Bahr O, et al. Costs and cost-driving factors for acute treatment of adults with status epilepticus: A multicenter cohort study from Germany. Epilepsia, 2016, 57(12): 2056-2066.
2. Kortland LM, Knake S, Rosenow F, et al. Cost of status epilepticus: A systematic review. Seizure, 2015, 24: 17-20.
3. Ferlisi M, Shorvon S. The outcome of therapies in refractory and super-refractory convulsive status epilepticus and recommendations for therapy. Brain, 2012, 135(Pt 8): 2314-2328.
4. Shorvon S, Ferlisi M. The treatment of super-refractory status epilepticus: a critical review of available therapies and a clinical treatment protocol. Brain, 2011, 134(Pt 10): 2802-2818.
5. Perucca E. What is the promise of new antiepileptic drugs in status epilepticus? Focus on brivaracetam, carisbamate, lacosamide, NS-1209, and topiramate. Epilepsia, 2009, 50(Suppl 12): 49-50.
6. Glauser T, Ben-Menachem E, Bourgeois B, et al. Updated ILAE evidence review of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes. Epilepsia, 2013, 54(3): 551-563.
7. Wechsler RT, Li G, French J, et al. Conversion to lacosamide monotherapy in the treatment of focal epilepsy: Results from a historical-controlled, multicenter, double-blind study. Epilepsia, 2014, 55(7): 1088-1098.
8. Baulac M, Rosenow F, Toledo M, et al. Efficacy, safety, and tolerability of lacosamide monotherapy versus controlled-release carbamazepine in patients with newly diagnosed epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurol, 2017, 16(1): 43-54.
9. Doty P, Hebert D, Mathy FX, et al. Development of lacosamide for the treatment of partial-onset seizures. Ann N Y Acad Sci, 2013, 1291: 56-68.
10. Doty P, Rudd GD, Stoehr T, et al. Lacosamide. Neurotherapeutics, 2007, 4(1): 145-148.
11. Cawello W, Stockis A, Andreas JO, et al. Advances in epilepsy treatment: Lacosamide pharmacokinetic profile. Ann N Y Acad Sci, 2014, 1329: 18-32.
12. Cawello W, Boekens H, Bonn R. Absorption, disposition, metabolic fate and elimination of the anti-epileptic drug lacosamide in humans: mass balance following intravenous and oral administration. Eur J Drug Metab Pharmacokinet, 2012, 37(4): 241-248.
13. Ben-Menachem E, Biton V, Jatuzis D, et al. Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures. Epilepsia, 2007, 48(7): 1308-1317.
14. Chung S, Sperling MR, Biton V, et al. Lacosamide as adjunctive therapy for partial-onset seizures: A randomized controlled trial. Epilepsia, 2010, 51(6): 958-967.
15. Halasz P, Kalviainen R, Mazurkiewicz-Beldzinska M, et al. Adjunctive lacosamide for partial-onset seizures: efficacy and safety results from a randomized controlled trial. Epilepsia, 2009, 50(3): 443-453.
16. Baulac M, Rosenow F, Toledo M, et al. Efficacy and tolerability of lacosamide monotherapy in patients with newly diagnosed epilepsy: a randomized double-blind trial versus controlled release carbamazepine. Eur J Neurol, 2016, 23: 52.
17. Rosenfeld W, Fountain NB, Kaubrys G, et al. Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years. Epilepsy Behav, 2014, 41: 164-170.
18. Husain A, Chung S, Faught E, et al. Long-term safety and efficacy in patients with uncontrolled partial-onset seizures treated with adjunctive lacosamide: results from a Phase III open-label extension trial. Epilepsia, 2012, 53(3): 521-528.
19. Rosenow F, Kelemen A, Ben-Menachem E, et al. Long-term adjunctive lacosamide treatment in patients with partial-onset seizures. Acta Neurol Scand, 2016, 133: 136-144.
20. Steinhoff BJ, Eckhardt K, Doty P, et al. A long-term noninterventional safety study of adjunctive lacosamide therapy in patients with epilepsy and uncontrolled partial-onset seizures. Epilepsy Behav, 2016, 58: 35-43.
21. Wehner T, Bauer S, Hamer HM, et al. Six months of postmarketing experience with adjunctive lacosamide in patients with pharmacoresistant focal epilepsy at a tertiary epilepsy center in germany. Epilepsy Behav, 2009, 16(3): 423-425.
22. Biton V, Rosenfeld WE, Whitesides J, et al. Intravenous lacosamide as replacement for oral lacosamide in patients with partial-onset seizures. Epilepsia, 2008, 49(3): 418-424.
23. Cawello W, Bonn R, Boekens H. Bioequivalence of intravenous and oral formulations of the antiepileptic drug lacosamide. Pharmacology, 2012, 90(1-2): 40-46.
24. Fountain NB, Krauss G, Isojarvi J, et al. Safety and tolerability of adjunctive lacosamide intravenous loading dose in lacosamide-naïve patients with partial-onset seizures. Epilepsia, 2013, 54(1): 58-65.
25. Höfler J, Trinka E. Lacosamide as a new treatment option in status epilepticus. Epilepsia, 2013, 54(3): 393-404.
26. Bauer S, Willems LM, Paule E, et al. The efficacy of lacosamide as monotherapy and adjunctive therapy in focal epilepsy and its use in status epilepticus: clinical trial evidence and experience. Ther Adv Neurol Disord, 2017, 10(2): 103-126.
27. Albers JM, Moddel G, Dittrich R, et al. Intravenous lacosamide-an effective add-on treatment of refractory status epilepticus. Seizure, 2011, 20(5): 428-430.
28. Cherry S, Judd L, Muniz JC, et al. Safety and efficacy of lacosamide in the intensive care unit. Neurocrit Care, 2012, 16(2): 294-298.
29. Goodwin H, Hinson HE, Shermock KM, et al. The use of lacosamide in refractory status epilepticus. Neurocrit Care, 2011, 14(3): 348-353.
30. Jain V, Harvey AS. Treatment of refractory tonic status epilepticus with intravenous lacosamide. Epilepsia, 2012, 53(4): 761-762.
31. Koubeissi MZ, Mayor CL, Estephan B, et al. Efficacy and safety of intravenous lacosamide in refractory nonconvulsive status epilepticus. Acta Neurol Scand, 2011, 123(2): 142-146.
32. Rantsch K, Walter U, Wittstock M, et al. Efficacy of intravenous lacosamide in refractory nonconvulsive status epilepticus and simple partial status epilepticus. Seizure, 2011, 20(7): 529-532.
33. Mnatsakanyan L, Chung JM, Tsimerinov EI, et al. Intravenous lacosamide in refractory nonconvulsive status epilepticus. Seizure, 2012, 21(3): 198-201.
34. Höfler J, Unterberger I, Dobesberger J, et al. Intravenous lacosamide in status epilepticus and seizure clusters. Epilepsia, 2011, 52(10): e148-e152.
35. Kellinghaus C, Berning S, Immisch I, et al. Intravenous lacosamide for treatment of status epilepticus. Acta Neurol Scand, 2011, 123(2): 137-141.
36. Granda-Mendez J, Toledo M, Flores-Flores A, et al. Intravenous lacosamide in monotherapy in a case of complex partial epileptic status. Rev Neurol, 2011, 53(1): 61-63, authors reply 64.
37. Kellinghaus C, Berning S, Besselmann M. Intravenous lacosamide as successful treatment for nonconvulsive status epilepticus after failure of first-line therapy. Epilepsy Behav, 2009, 14(2): 429-431.
38. Tilz C, Resch R, Hofer T, et al. Successful treatment for refractory convulsive status epilepticus by non-parenteral lacosamide. Epilepsia, 2010, 51(2): 316-317.
39. Turpin-Fenoll L, Millan-Pascual J, Navarro-Munoz S, et al. The use of oral lacosamide in a patient with refractory partial epileptic status. Rev Neurol, 2010, 50(10): 603-606.
40. Chen LL, Haneef Z, Dorsch A, et al. Successful treatment of refractory simple motor status epilepticus with lacosamide and levetiracetam. Seizure, 2011, 20(3): 263-265.
41. Krause LU, Brodowski KO, Kellinghaus C. Atrioventricular block following lacosamide intoxication. Epilepsy Behav, 2011, 20(4): 725-727.
42. Parkerson KA, Reinsberger C, Chou SH, et al. Lacosamide in the treatment of acute recurrent seizures and periodic epileptiform patterns in critically ill patients. Epilepsy Behav, 2011, 20(1): 48-51.
43. Torres-Cano N, Giner Bayarri P, Chilet-Chilet MR, et al. Refractory nonconvulsive status epilepticus. Rev Neurol, 2011, 53(4): 255-256.
44. LaRoche SM, Shivdat-Nanhoe R. Subacute encephalopathy and seizures in alcoholics (SESA) presenting with non-convulsive status epilepticus. Seizure, 2011, 20(6): 505-508.
45. Shiloh-Malawsky Y, Fan Z, Greenwood R, et al. Successful treatment of childhood prolonged refractory status epilepticus with lacosamide. Seizure, 2011, 20(7): 586-588.
46. Belcastro V, Vidale S, Pierguidi L, et al. Intravenous lacosamide as treatment option in post-stroke non convulsive status epilepticus in the elderly: a proof-of-concept, observational study. Seizure, 2013, 22(10): 905-907.
47. Kaplan PW. EEG criteria for nonconvulsive status epilepticus. Epilepsia, 2007, 48(Suppl 8): 39-41.
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拉科酰胺在癫痫持续状态中的应用 —针对现有证据的系统评价

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拉科酰胺在癫痫持续状态中的应用　　—针对现有证据的系统评价