Ben-Menachem Elinor
University of Göteborg, Sahlgren Hospital, Göteborg, Sweden.
Epileptic Disord. 2003 May;5 Suppl 1:S51-5.
The standard of care for prescribing antiepileptic drugs (AEDs) has come to favor the use of monotherapy when possible; i.e., when compa-rable efficacy can be achieved with fewer risks of adverse events and drug interactions. Most patients with epilepsy are started on one of the classic AEDs and, if it proves ineffective, another drug is tried, usually as monotherapy. While most of the newer AEDs that have come into clinical use in recent years are initially used as add-on therapy, their success at improving seizure control in combination treatments has led to their cautious use as monotherapy even before they have been approved for this indication. As a first study to determine the potential efficacy of levetiracetam in monotherapy, a withdrawal trial model was used. Patients who achieved adequate seizure control with levetiracetam as add-on therapy in a double-blind, placebo-controlled study entered a monotherapy phase of the trial in which the baseline AED was gradually withdrawn. Also, long-term data of 505 patients who received levetiracetam for refractory partial seizures were reviewed and found to include 49 patients still treated with levetiracetam monotherapy at the end of the study for a duration between 3 months and 5.5 years. Data from patients in the two trials lend supportive evidence that levetiracetam monotherapy is safe and effective for partial seizures.
在开具抗癫痫药物（AEDs）时，护理标准倾向于尽可能采用单一疗法；也就是说，当使用较少药物且能降低不良事件风险和药物相互作用风险时，仍可达到相当的疗效。大多数癫痫患者一开始使用一种经典的AEDs，如果证明无效，则尝试使用另一种药物，通常也是单一疗法。虽然近年来临床使用的大多数新型AEDs最初都用作附加疗法，但它们在联合治疗中改善癫痫发作控制方面的成功，导致人们在这些药物被批准用于该适应症之前，就谨慎地将其用作单一疗法。作为确定左乙拉西坦单一疗法潜在疗效的第一项研究，采用了撤药试验模型。在一项双盲、安慰剂对照研究中，以附加疗法使用左乙拉西坦实现充分癫痫发作控制的患者进入试验的单一疗法阶段，在此阶段逐渐停用基线AEDs。此外，对505例接受左乙拉西坦治疗难治性部分性癫痫的患者的长期数据进行了回顾，发现在研究结束时，有49例患者仍在接受左乙拉西坦单一疗法治疗，持续时间为3个月至5.5年。两项试验中患者的数据提供了支持性证据，表明左乙拉西坦单一疗法对部分性癫痫安全有效。
