Dooley M, Plosker G L
Adis International Limited, Mairangi Bay, Auckland, New Zealand.
Drugs. 2000 Oct;60(4):871-93. doi: 10.2165/00003495-200060040-00004.
Levetiracetam, the S-enantiomer of alpha-ethyl-2-oxo-1-pyrollidine acetamide, is approved for use as adjunctive therapy in adult patients with partial onset seizures. Oral levetiracetam 1000, 2000 and 3000 mg/day administered as adjunctive therapy for up to 18 weeks significantly increased responder rates and reduced seizure frequency compared with placebo in 3 well designed pivotal trials in adults with treatment-refractory partial seizures with or without secondary generalisation. Levetiracetam 3000 mg/day also significantly increased the number of seizure-free patients, but the effects of levetiracetam 1000 and 2000 mg/day on this end-point were unclear. Effects on seizure severity were not assessed in these trials. Although not yet approved as monotherapy or for use in paediatric patients, efficacy was observed with levetiracetam 3000 mg/day as monotherapy in adult patients with refractory partial seizures with or without secondary generalisation and with the 10 to 40 mg/kg/day dosage as adjunctive therapy in children with refractory partial seizures. However, these data are limited. Oral levetiracetam 1000, 2000 and 3000 mg/day as adjunctive therapy is generally well tolerated with an overall incidence of adverse events similar to that observed with placebo. The most commonly reported events in individual clinical trials were CNS-related and included somnolence, asthenia, headache and dizziness. Levetiracetam administered as adjunctive therapy does not appear to interact with other anticonvulsant drugs, and no clinically relevant interactions were observed between levetiracetam and digoxin, warfarin or probenecid; oral contraceptive protective efficacy was also not affected by levetiracetam.
Levetiracetam is a new anticonvulsant agent with a favourable tolerability profile and a low potential for drug interactions. It has shown efficacy as adjunctive therapy in patients with treatment-refractory partial onset seizures with or without secondary generalisation in clinical trials. Direct comparative trials with other anticonvulsant agents are not yet available, but placebo-controlled clinical evidence to date suggests that levetiracetam (1000, 2000 and 3000 mg/day) is a useful option as adjunctive therapy in patients with this subtype of epilepsy.
左乙拉西坦是α-乙基-2-氧代-1-吡咯烷乙酰胺的S-对映体，已被批准用于成年部分性发作患者的辅助治疗。在3项针对有或无继发性全面发作的难治性部分性发作成年患者的精心设计的关键试验中，与安慰剂相比，口服左乙拉西坦1000、2000和3000mg/天作为辅助治疗长达18周可显著提高缓解率并降低癫痫发作频率。左乙拉西坦3000mg/天也显著增加了无癫痫发作患者的数量，但左乙拉西坦1000和2000mg/天对这一终点的影响尚不清楚。这些试验未评估对癫痫发作严重程度的影响。虽然左乙拉西坦尚未被批准作为单一疗法或用于儿科患者，但在有或无继发性全面发作的难治性部分性发作成年患者中，观察到左乙拉西坦3000mg/天作为单一疗法有效，在难治性部分性发作儿童中，10至40mg/kg/天的剂量作为辅助治疗有效。然而，这些数据有限。口服左乙拉西坦1000、2000和3000mg/天作为辅助治疗一般耐受性良好，不良事件的总体发生率与安慰剂相似。个别临床试验中最常报告的事件与中枢神经系统相关，包括嗜睡、乏力、头痛和头晕。左乙拉西坦作为辅助治疗似乎不与其他抗惊厥药物相互作用，在左乙拉西坦与地高辛、华法林或丙磺舒之间未观察到临床相关的相互作用；左乙拉西坦也未影响口服避孕药的保护效果。
左乙拉西坦是一种新的抗惊厥药物，耐受性良好，药物相互作用可能性低。在临床试验中，它已显示出作为有或无继发性全面发作的难治性部分性发作患者辅助治疗的疗效。目前尚无与其他抗惊厥药物的直接对比试验，但迄今为止的安慰剂对照临床证据表明，左乙拉西坦（1000、2000和3000mg/天）作为这种癫痫亚型患者的辅助治疗是一种有用的选择。
