拉考沙胺—部分性癲癇發作的新選擇_Journal of Epilepsy

Authors：

虞培敏 ,  洪震

復旦大學附華山醫院神經內科（上海 200040）;

Corresponding?author：

洪震, Email: hongzhen@medmail.com.cn

Keywords：

部分性癲癇; 拉考沙胺; 鈉離子通道阻滯劑; 抗癲癇藥物

DOI：

10.7507/2096-0247.20190059

Video：

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癲癇是神經科最常見的疾病之一，目前其治療主要依賴于藥物。傳統抗癲癇藥物（AEDs）通常不良反應較多，多和其他藥物之間存在相互作用。拉考沙胺（LCM）作為第三代新型 AEDs，于 2008 年在美國上市，是目前唯一已知選擇性作用于慢失活鈉通道 AEDs，現歐美已獲得≥4 歲部分性癲癇患者添加及單藥治療的適應證。在中日臨床試驗中作為≥16 歲難治性部分性發作癲癇患者的添加治療，16 周 50% 有效率高達 49.2%。此外，真實世界研究也證明了 LCM 早期添加治療 6 個月癲癇無發作率可達 45.5%。安全性方面，長達 8 年的開放標簽研究顯示長期用藥耐受性好，不良反應多為輕中度，主要包括頭暈、頭痛、惡心、復視等。

Citation： 虞培敏, 洪震. 拉考沙胺—部分性癲癇發作的新選擇. Journal of Epilepsy, 2019, 5(5): 367-371. doi: 10.7507/2096-0247.20190059 Copy

1.	Moshe SL, Perucca E, Ryvlin P, et al. Epilepsy: new advances. Lancet, 2015, 385(9971): 884-898.
2.	Mantegazza M, Curia G, Biagini G, et al. Voltage-gated sodium channels as therapeutic targets in epilepsy and other neurological disorders. Lancet Neurol, 2010, 9(4): 413-424.
3.	Masino SA, Rho JM. Mechanisms of Ketogenic Diet Action. In: Noebels JL, Avoli M, Rogawski MA, et al. editor, Jasper's basic mechanisms of the epilepsies, Bethesda (MD): National Center for Biotechnology Information (US); 2012.
4.	Hoy SM. Lacosamide: a review in focal-onset seizures in patients with epilepsy. CNS Drugs, 2018, 32(5): 473-484.
5.	Beydoun A, D'souza J, Hebert D, et al. Lacosamide: pharmacology, mechanisms of action and pooled efficacy and safety data in partial-onset seizures. Expert Rev Neurother, 2009, 9(1): 33-42.
6.	Cawello W. Clinical pharmacokinetic and pharmacodynamic profile of lacosamide. Clin Pharmacokinet, 2015, 54(9): 901-914.
7.	Doty P, Hebert D, Mathy FX, et al. Development of lacosamide for the treatment of partial-onset seizures. Ann NY Acad Sci, 2013, 1291: 56-68.
8.	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.
9.	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.
10.	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.
11.	Chung S, Ben-Menachem E, Sperling MR, et al. Examining the clinical utility of lacosamide: pooled analyses of three phase II/III clinical trials. CNS Drugs, 2010, 24(12): 1041-1054.
12.	Hong Z, Inoue Y, Liao W, et al. Efficacy and safety of adjunctive lacosamide for the treatment of partial-onset seizures in Chinese and Japanese adults: A randomized, double-blind, placebo-controlled study. Epilepsy Res, 2016, 127: 267-275.
13.	Runge U, Arnold S, Brandt C, et al. A noninterventional study evaluating the effectiveness and safety of lacosamide added to monotherapy in patients with epilepsy with partial-onset seizures in daily clinical practice: The VITOBA study. Epilepsia, 2015, 56(12): 1921-1930.
14.	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.
15.	Hemery C, Ryvlin P, Rheims S. Prevention of generalized tonic-clonic seizures in refractory focal epilepsy: a meta-analysis. Epilepsia, 2014, 55(11): 1789-1799.
16.	Ortiz De La Rosa JS, Ladino LD, Rodriguez PJ, et al. Efficacy of lacosamide in children and adolescents with drug-resistant epilepsy and refractory status epilepticus: a systematic review. Seizure, 2018, 56: 34-40.
17.	Grosso S, Parisi P, Giordano L, et al. Lacosamide efficacy in epileptic syndromes with continuous spike and waves during slow sleep (CSWS). Epilepsy Res, 2014, 108(9): 1604-1608.
18.	Villanueva V, Garces M, Lopez-Gomariz E, et al. Early add-on lacosamide in a real-life setting: results of the REALLY study. Clin Drug Investig, 2015, 35(2): 121-131.
19.	Villanueva V, Lopez FJ, Serratosa JM, et al. Control of seizures in different stages of partial epilepsy: LACO-EXP, a Spanish retrospective study of lacosamide. Epilepsy Behav, 2013, 29(2): 349-356.
20.	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.
21.	Harden CL, Cohn A, Lowe M, et al. Initial post marketing experience with lacosamide in adult patients with epilepsy. Epilepsy Res, 2012, 98(2-3): 260-263.
22.	Wechsler RT, Yates SL, Messenheimer J, et al. Lacosamide for uncontrolled primary generalized tonic-clonic seizures: An open-label pilot study with 59-week extension. Epilepsy Res, 2017, 130: 13-20.
23.	Alcantara-Montero A, Sanchez-Carnerero CI. [Lacosamide and neuropathic pain, a review]. Rev Neurol, 2016, 62(5): 223-229.
24.	Biton V. Lacosamide for the treatment of diabetic neuropathic pain. Expert Rev Neurother, 2008, 8(11): 1649-1660.
25.	Biton V, Gil-Nagel A, Isojarvi J, et al. Safety and tolerability of lacosamide as adjunctive therapy for adults with partial-onset seizures: analysis of data pooled from three randomized, double-blind, placebo-controlled clinical trials. Epilepsy Behav, 2015, 52(Pt A): 119-127.
26.	Nakhutina L, Kunnakkat SD, Coleman M, et al. Effects of adjunctive lacosamide on mood and quality of life in patients with epilepsy. Epilepsy Behav, 2017, 73: 90-94.
27.	Lancman ME, Fertig EJ, Trobliger RW, et al. The effects of lacosamide on cognition, quality-of-life measures, and quality of life in patients with refractory partial epilepsy. Epilepsy Behav, 2016, 61: 27-33.
28.	Kim GH, Byeon JH, Eun BL. Neuroprotective effect of lacosamide on hypoxic-ischemic brain injury in neonatal rats. J Clin Neurol, 2017, 13(2): 138-143.
29.	Rizzo A, Donzelli S, Girgenti V, et al. In vitro antineoplastic effects of brivaracetam and lacosamide on human glioma cells. J Exp Clin Cancer Res, 2017, 36(1): 76.

1. Moshe SL, Perucca E, Ryvlin P, et al. Epilepsy: new advances. Lancet, 2015, 385(9971): 884-898.
2. Mantegazza M, Curia G, Biagini G, et al. Voltage-gated sodium channels as therapeutic targets in epilepsy and other neurological disorders. Lancet Neurol, 2010, 9(4): 413-424.
3. Masino SA, Rho JM. Mechanisms of Ketogenic Diet Action. In: Noebels JL, Avoli M, Rogawski MA, et al. editor, Jasper's basic mechanisms of the epilepsies, Bethesda (MD): National Center for Biotechnology Information (US); 2012.
4. Hoy SM. Lacosamide: a review in focal-onset seizures in patients with epilepsy. CNS Drugs, 2018, 32(5): 473-484.
5. Beydoun A, D'souza J, Hebert D, et al. Lacosamide: pharmacology, mechanisms of action and pooled efficacy and safety data in partial-onset seizures. Expert Rev Neurother, 2009, 9(1): 33-42.
6. Cawello W. Clinical pharmacokinetic and pharmacodynamic profile of lacosamide. Clin Pharmacokinet, 2015, 54(9): 901-914.
7. Doty P, Hebert D, Mathy FX, et al. Development of lacosamide for the treatment of partial-onset seizures. Ann NY Acad Sci, 2013, 1291: 56-68.
8. 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.
9. 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.
10. 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.
11. Chung S, Ben-Menachem E, Sperling MR, et al. Examining the clinical utility of lacosamide: pooled analyses of three phase II/III clinical trials. CNS Drugs, 2010, 24(12): 1041-1054.
12. Hong Z, Inoue Y, Liao W, et al. Efficacy and safety of adjunctive lacosamide for the treatment of partial-onset seizures in Chinese and Japanese adults: A randomized, double-blind, placebo-controlled study. Epilepsy Res, 2016, 127: 267-275.
13. Runge U, Arnold S, Brandt C, et al. A noninterventional study evaluating the effectiveness and safety of lacosamide added to monotherapy in patients with epilepsy with partial-onset seizures in daily clinical practice: The VITOBA study. Epilepsia, 2015, 56(12): 1921-1930.
14. 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.
15. Hemery C, Ryvlin P, Rheims S. Prevention of generalized tonic-clonic seizures in refractory focal epilepsy: a meta-analysis. Epilepsia, 2014, 55(11): 1789-1799.
16. Ortiz De La Rosa JS, Ladino LD, Rodriguez PJ, et al. Efficacy of lacosamide in children and adolescents with drug-resistant epilepsy and refractory status epilepticus: a systematic review. Seizure, 2018, 56: 34-40.
17. Grosso S, Parisi P, Giordano L, et al. Lacosamide efficacy in epileptic syndromes with continuous spike and waves during slow sleep (CSWS). Epilepsy Res, 2014, 108(9): 1604-1608.
18. Villanueva V, Garces M, Lopez-Gomariz E, et al. Early add-on lacosamide in a real-life setting: results of the REALLY study. Clin Drug Investig, 2015, 35(2): 121-131.
19. Villanueva V, Lopez FJ, Serratosa JM, et al. Control of seizures in different stages of partial epilepsy: LACO-EXP, a Spanish retrospective study of lacosamide. Epilepsy Behav, 2013, 29(2): 349-356.
20. 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.
21. Harden CL, Cohn A, Lowe M, et al. Initial post marketing experience with lacosamide in adult patients with epilepsy. Epilepsy Res, 2012, 98(2-3): 260-263.
22. Wechsler RT, Yates SL, Messenheimer J, et al. Lacosamide for uncontrolled primary generalized tonic-clonic seizures: An open-label pilot study with 59-week extension. Epilepsy Res, 2017, 130: 13-20.
23. Alcantara-Montero A, Sanchez-Carnerero CI. [Lacosamide and neuropathic pain, a review]. Rev Neurol, 2016, 62(5): 223-229.
24. Biton V. Lacosamide for the treatment of diabetic neuropathic pain. Expert Rev Neurother, 2008, 8(11): 1649-1660.
25. Biton V, Gil-Nagel A, Isojarvi J, et al. Safety and tolerability of lacosamide as adjunctive therapy for adults with partial-onset seizures: analysis of data pooled from three randomized, double-blind, placebo-controlled clinical trials. Epilepsy Behav, 2015, 52(Pt A): 119-127.
26. Nakhutina L, Kunnakkat SD, Coleman M, et al. Effects of adjunctive lacosamide on mood and quality of life in patients with epilepsy. Epilepsy Behav, 2017, 73: 90-94.
27. Lancman ME, Fertig EJ, Trobliger RW, et al. The effects of lacosamide on cognition, quality-of-life measures, and quality of life in patients with refractory partial epilepsy. Epilepsy Behav, 2016, 61: 27-33.
28. Kim GH, Byeon JH, Eun BL. Neuroprotective effect of lacosamide on hypoxic-ischemic brain injury in neonatal rats. J Clin Neurol, 2017, 13(2): 138-143.
29. Rizzo A, Donzelli S, Girgenti V, et al. In vitro antineoplastic effects of brivaracetam and lacosamide on human glioma cells. J Exp Clin Cancer Res, 2017, 36(1): 76.

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