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专家意见:布立西坦在癫痫治疗中的应用

A. V.1, 库马 尔·2, 阿兰 达蒂2, 苏克 普雷2
1、MGR 医科大学神经内科
2、雷迪博士实验室有限公司

摘要


癫痫很普遍,全世界约有 5000 万患者受到影响。印度在癫痫管理方面存在许多治疗差距。在抗癫痫药物 (AED) 中,
布立西坦是一种用于突触囊泡 2A 的高亲和力、选择性和可逆配体,已被美国食品药品监督管理局批准用于局灶性癫痫发作
的单药治疗和辅助治疗。 2020 年 4 月举行的一系列会议邀请了印度各地的神经科医生作为小组成员,回顾了布伐西坦的有
效性和安全性,并讨论了在临床环境中使用布伐西坦以及使用布伐西坦治疗癫痫的驱动因素和障碍。布立西坦作为辅助治疗
16 岁及以上患者局灶性(部分发作)癫痫发作具有良好的疗效和耐受性。布立西坦在癫痫患者和癫痫儿童中长期使用是安全
的。布立西坦最常见的不良事件与中枢神经系统有关,包括疲劳、头晕和嗜睡; 这些可能会在治疗期间改善或消退。寻求在
常规神经病学实践中使用布立西坦进行癫痫管理的共识 布立西坦是一种更安全的 AED,行为不良事件较少,无认知障碍,
并且没有临床相关的药物相互作用或肾脏患者的剂量调整。

关键词


布立西坦;癫痫;粪便发作;辅助治疗;抗癫痫药

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参考


[1] Santhosh NS, Sinha S, Satishchandra P. Epilepsy:

Indian perspective. Ann Indian Acad Neurol. 2014; 17: S3-S11. [2] Meyer AC, Dua T, Ma J, Shekhar S, Birbeck G. Global

disparities in the epilepsy treatment gap: a systematic review. Bull World Health Organ. 2010 Apr; 88: 260-6. [3] Haroon A, Tripathi M, Khanam R, Vohora D. Antiepileptic drugs prescription utilization behavior and direct costs of treatment in a national hospital of India. Ann Indian Acad Neurol. 2012; 15: 289-293. [4] Duncan JS. The promise of new antiepileptic drugs. Br J Clin Pharmacol. 2002; 53: 123-131. [5] Hanaya R, Arita K. The New Antiepileptic Drugs: Their Neuropharmacology and Clinical Indications. Neurol Med Chir

(Tokyo). 2016; 56: 205-220. [6] Perucca E, Meador KJ. Adverse effects of antiepileptic drugs. Acta Neurol Scand Suppl. 2005; 181: 30-35. [7] Gillard M, Fuks B, Leclercq K, Matagne A. Binding

characteristics of brivaracetam, a selective, high affinity SV2A

ligand in rat, mouse and human brain: relationship to

anti-convulsant properties. Eur J Pharmacol. 2011; 664: 36−44. [8] US Food and Drug Administration. Brivaracetam

[prescribing information]. 2016. Available from: https://www.fda.gov/news-events/press-announcements/fdaappr oves-briviact-treat-partial-onset-seizures. Accessed June 15, 2020.[9] Rigo JM, Nguyen L, Hans G. UCB 34714: effect on

inhibitory and excitatory neurotransmission. Epilepsia. 2004; 45: 56. [10] Niespodziany I, Lukyanetz EA, Matagne A, Matagne A, Klitgaard H, Wolff C. Brivaracetam does not modulate the major ionic conductances in neurons. Epilepsia. 2015;

56192–193. [11] Kostyuk PG, Lukyanetz EA, Klitgaard H, Margineanu D-G. UCB 34714, a new pyrrolidone derivative, without impact on high- and low-voltage activated calcium currents in rat

isolated neurons. Epilepsia. 2004; 45: 141. [12] Otoul C, Watanabe S, McCabe S, Stockis A. Relative bioavailability and bioequivalence of brivaracetam 10 mg/mL

oral solution and 50-mg film-coated tablet. Clin Pharmacol

Drug Dev. 2017; 6: 313–317. [13] Sargentini-Maier ML, Rolan P, Connell J, Tytgat D, Jacobs T, Pigeolet E. The pharmacokinetics, CNS

pharmacodynamics and adverse event profile of brivaracetam

after single increasing oral doses in healthy males. Br J Clin Pharmacol. 2007; 63: 680–688. [14] Rolan P, Sargentini-Maier ML, Pigeolet E, Stockis A. The pharmacokinetics, CNS pharmacodynamics and adverse

event profile of brivaracetam after multiple increasing oral

doses in healthy men. Br J Clin Pharmacol. 2008; 66: 71-75. [15] Sargentini-Maier ML, Espié P, Coquette A, Stockis A. Pharmacokinetics and metabolism of 14C-brivaracetam, a novel

SV2A ligand, in healthy subjects. Drug Metab Dispos. 2008; 36: 36–45. [16] Stockis A, Sargentini-Maier ML, Horsmans Y. Brivaracetam disposition in mild to severe hepatic impairment. J

Clin Pharmacol. 2013; 53: 633–64. [17] Bialer M, Johannessen SI, Levy RH, Perucca E, Tomson T, White HS. Progress report on new antiepileptic drugs: a summary of the tenth Eilat Conference (EILATX). Epilepsy

Res. 2010; 92: 89–124. [18] Nicolas JM, Hannestad J, Holden D, Kervyn S

Nabulsi N, Tytgat D et al. Brivaracetam, a selective high-affinity

synaptic vesicle protein 2A (SV2A) ligand with preclinical evidence of high brain permeability and fast onset of action. Epilepsia. 2016; 57: 201–209. [19] Feyissa AM. Brivaracetam in the treatment of epilepsy: a review of clinical trial data. Neuropsychiatr Dis Treat. 2019;

15: 2587-2600. [20] Stockis A, Watanabe S, Fauchoux N. Interaction

between brivaracetam (100mg/day) and a combination oral contraceptive: a randomized, double-blind, placebo-controlled

study. Epilepsia. 2014; 55: e27–e31. [21] Stockis A, Watanabe S, Scheen AJ, Tytgat D, Gerin D, Rosa M, et al. Effect of rifampin on the disposition of

brivaracetam in human subjects: further insights into

brivaracetam hydrolysis. Drug Metab Dispos. 2016; 44: 792–799. [22] Doganavsargil-Baysal O, Cinemre B, Senol Y, Barcin E, Gokmen Z. Epilepsy and stigmatization in Turkey. J Epilepsy

Behavior. 2017; 73: 100-5. [23] Robertson J, Hatton C, Emerson E, Baines S. Prevalence of epilepsy among people with intellectual

disabilities: A systematic review. Seizure. 2015; 29: 46-62.

[24] Jaiswal S, Kumar S, Sharma CS, Kuchhal A, Jaiswal

A. Psychiatric Comorbidities in Patients with Epilepsy: A

Crosssectional Study. Int J Adv Integ Med Sci 2017; 2: 24-28. [25] Michaelis R, Tang V, Wagner JL, Modi AC, LaFrance WC Goldstein LH, et al. Psychological treatments for people with epilepsy. Cochrane Database Syst Rev. 2017; 10: CD012081. [26] Gur-Ozmen S, Leibetseder A, Cock HR, Agrawal N, von Oertzen TJ. Screening of anxiety and quality of life in

people with epilepsy. Seizure. 2017; 45: 107-113. [27] Zhu LN, Chen D, Chen T, Xu D, Chen SH, Liu L. The

adverse event profile of brivaracetam: A meta-analysis of

randomized controlled trials. Seizure. 2017; 45: 7-16. [28] Zhang L, Li S, Li H, Zou X. Levetiracetam vs. brivaracetam for adults with refractory focal seizures: A meta-analysis and indirect comparison. Seizure. 2016; 39: 28-33.[29] Klein P, Diaz A, Gasalla T, Whitesides J. A review of

the pharmacology and clinical efficacy of brivaracetam. Clin Pharmacol. 2018; 10: 1-22. [30] O’Brien TJ, Borghs S, He Q, Schulz AL, Yates S, Biton V. Long-term safety, efficacy, and quality of life outcomes with adjunctive brivaracetam treatment at individualized doses

in patients with epilepsy: An up to 11-year, open-label, followup

trial. Epilepsia 2020; 61: 636-646. [31] Lee SK. Epilepsy in the Elderly: Treatment and

Consideration of Comorbid Diseases. J Epilepsy Res. 2019; 9: 27-35.[32] Brodie MJ, Whitesides J, Schiemann J, D'Souza J, Johnson ME. Tolerability, safety, and efficacy of adjunctive brivaracetam for focal seizures in older patients: A pooled

analysis from three phase III studies. Epilepsy Res. 2016; 127: 114-118. [33] Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B et al. Safety, tolerability, and seizure

control during long-term treatment with adjunctive brivaracetam

for partial-onset seizures. Epilepsia. 2016 Jul; 57: 1139-51. [34] Coppola G, Iapadre G, Operto FF, Verrotti A. New

developments in the management of partial-onset epilepsy: role of brivaracetam. Drug Des Devel Ther. 2017; 11: 643-657. [35] Strzelczyk A, Steinig I, Willems LM, Reif PS, Senft C,

Voss M, et al. Treatment of refractory and super-refractory

status epilepticus with brivaracetam: A cohort study from two German university hospitals. Epilepsy Behav. 2017; 70: 177-181. [36] Klein P, Johnson ME, Schiemann J, Whitesides J. Time to onset of sustained ≥50% responder status in patients with focal (partial-onset) seizures in three phase III studies of adjunctive brivaracetam treatment. Epilepsia. 2017; 58: e21–e25. [37] Villanueva V, López-González FJ, Mauri JA, Uranga

JR, Gadea MO, Montoya J et al. BRIVA-LIFE-A multicenter

retrospective study of the long-term use of brivaracetam in

clinical practice. Acta Neurol Scand. 2019; 139: 360-368. [38] Schoemaker R, Wade JR, D'Souza J, Stockis A. Evaluation of brivaracetam efficacy as monotherapy in adult

patients with focal seizures. Epilepsy Res. 2017; 137: 95-100. [39] Witt JA, Elger CE, Helmstaedter C. Short-term and

longerterm effects of brivaracetam on cognition and behavior in

a naturalistic clinical setting-Preliminary data. Seizure. 2018; 62: 49-54.[40] Liu E, Dilley D, McDonough B, Stockis A, Daniels T. Safety and Tolerability of Adjunctive Brivaracetam in Pediatric Patients < 16 Years with Epilepsy: An Open-Label Trial. Paediatr Drugs. 2019; 21: 291-301. [41] Yates SL, Fakhoury T, Liang W, Eckhardt K, Borghs S, D’Souza J. An open-label, prospective, exploratory study of

patients with epilepsy switching from Levetiracetam to Brivaracetam. Epilepsy Behav 2015; 52: 165–8. [42] Brodie MJ, Fakhoury T, McDonough B, Colson AO, Stockis A, Elmoufti S, et al. Brivaracetam-induced elevation of carbamazepine epoxide levels: a post-hoc analysis from the

clinical development program. Epilepsy Res. 2018; 145: 55–62. [43] Stockis A, Chanteux H, Rosa M, Rolan P. Brivaracetam and carbamazepine interaction in healthy subjects and in vitro. Epilepsy Res. 2015; 113: 19–27. [44] Kwan P, Brodie MJ. Epilepsy after the first drug fails: substitution or add-on? Seizure. 2000 Oct; 97: 464-8. [45] Biton V, Berkovic SF, Abou-Khalil B, Sperling MR, Johnson ME, Lu S. Brivaracetam as adjunctive treatment for uncontrolled partial epilepsy in adults: a phase III randomized, double-blind, placebo-controlled trial. Epilepsia. 2014; 55:

57-66.[46] Ryvlin P, Werhahn KJ, Blaszczyk B, Johnson ME, Lu S. Adjunctive brivaracetam in adults with uncontrolled focal epilepsy: results from a double-blind, randomized, placebocontrolled trial. Epilepsia. 2014; 55: 47-56. [47] Van Paesschen W, Hirsch E, Johnson M, Falter U, von Rosenstiel P. Efficacy and tolerability of adjunctive brivaracetam in adults with uncontrolled partial-onset seizures: a phase IIb, randomized, controlled trial. Epilepsia. 2013; 54: 89-97.[48] Steinhoff BJ, Bacher M, Bucurenciu I, Hillenbrand B,

Intravooth T, Kornmeier R. et al. Real-life experience with

brivaracetam in 101 patients with difficult-to-treat epilepsy-A monocenter survey. Seizure. 2017; 48: 11-14. [49] Ma J, Huang S, You C. Adjunctive brivaracetam for patients with refractory partial seizures: A meta-analysis of

randomized placebo-controlled trials. Epilepsy Res. 2015; 114: 59-65.[50] Lattanzi S, Cagnetti C, Foschi N, Provinciali L, Silvestrini M. Brivaracetam add-on for refractory focal epilepsy: A systematic review and meta-analysis. Neurology. 2016 Apr 5;

86: 1344-1352.


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