Smith D, Chadwick D, Baker G, Davis G, Dewey M
Department of Neuroscience, Walton Hospital, Liverpool, England.
Epilepsia. 1993;34 Suppl 5:S31-5. doi: 10.1111/j.1528-1157.1993.tb05921.x.
The efficacy of an antiepileptic drug (AED) is determined at present by the drug-elicited reduction in seizure frequency. Reduction of seizure frequency as the sole measure of efficacy does not account for treatment-induced reductions in seizure severity and positive psychological effects experienced by the patient. A clinical trial was undertaken in which seizure frequency was the primary and seizure severity and psychological well-being were the secondary measures of efficacy. Psychological assessment and seizure frequency were monitored in patients whose epilepsy was treated with lamotrigine (LTG) or placebo. The results indicate that LTG is an effective AED, causing reductions in seizure frequency and severity and improvements in mood and mastery. In addition, the study demonstrated that the use of seizure severity scales, especially the ictal subscale, may enhance the sensitivity of assessment of trials of AED treatments.
目前，抗癫痫药物（AED）的疗效是由药物引起的癫痫发作频率降低来确定的。将癫痫发作频率降低作为疗效的唯一衡量标准，并不能解释治疗引起的癫痫发作严重程度降低以及患者所体验到的积极心理效应。开展了一项临床试验，其中癫痫发作频率是疗效的主要衡量指标，癫痫发作严重程度和心理健康状况是疗效的次要衡量指标。对接受拉莫三嗪（LTG）或安慰剂治疗癫痫的患者进行了心理评估和癫痫发作频率监测。结果表明，LTG是一种有效的抗癫痫药物，可降低癫痫发作频率和严重程度，并改善情绪和掌控感。此外，该研究表明，使用癫痫发作严重程度量表，尤其是发作期分量表，可能会提高抗癫痫药物治疗试验评估的敏感性。
