Leppik Ilo, De Rue Katrien, Edrich Pascal, Perucca Emilio
University of Minnesota and MINCEP Epilepsy Care, Minneapolis, Minnesota, USA.
Epileptic Disord. 2006 Jun;8(2):118-30.
To assess the advantages and disadvantages of six methodologies used in calculating seizure freedom rates in placebo-controlled, adjunctive therapy trials of new antiepileptic drugs (AEDs) in partial epilepsy, and two methodologies for long-term follow-up studies.
Data from levetiracetam trials were used to illustrate the impact of different methodologies on seizure freedom rates. Seizure-freedom data for several new AEDs were identified from the published medical literature using MEDLINE and from a recent comprehensive textbook.
Most randomized, placebo-controlled add-on clinical trials of new AEDs contain little or no information about seizure freedom. Importantly, the methodology used can profoundly affect results when calculating seizure-free rates. Seizure freedom data should be reported as well as the methodology used. The minimum duration for assessing seizure freedom should be the entire stable dose period in short-term trials and at least six months for long-term follow-up studies. It is proposed that the seizure freedom rates be calculated and reported with at least two different methodologies, one that considers patients withdrawing from treatment without having had a seizure as successes, and one that considers the same patients as failures. For an effective and well-tolerated AED, seizure freedom rates will be consistent across the two methodologies.
Seizure freedom is the ultimate goal of AED therapy and should be reported for all clinical trials. Methodological differences among the few clinical studies reporting seizure freedom rates make it difficult to compare results across trials. Improved reporting of methodologies and seizure-free rates is warranted.
评估在部分性癫痫新抗癫痫药物（AEDs）的安慰剂对照辅助治疗试验中用于计算无癫痫发作率的六种方法的优缺点，以及两种用于长期随访研究的方法。
使用左乙拉西坦试验的数据来说明不同方法对无癫痫发作率的影响。通过MEDLINE从已发表的医学文献以及从最近的一本综合教科书中确定了几种新AEDs的无癫痫发作数据。
大多数新AEDs的随机、安慰剂对照附加临床试验几乎没有或根本没有关于无癫痫发作的信息。重要的是，在计算无癫痫发作率时所使用的方法会深刻影响结果。应报告无癫痫发作数据以及所使用的方法。在短期试验中评估无癫痫发作的最短持续时间应为整个稳定剂量期，而在长期随访研究中至少应为六个月。建议用至少两种不同的方法计算并报告无癫痫发作率，一种方法是将未发作就退出治疗的患者视为成功，另一种方法是将同样的患者视为失败。对于一种有效且耐受性良好的AED，两种方法的无癫痫发作率将是一致的。
无癫痫发作是AED治疗的最终目标，所有临床试验均应报告。少数报告无癫痫发作率的临床研究之间的方法学差异使得难以比较各试验的结果。有必要改进方法学和无癫痫发作率的报告。
