Chadwick D
University Department of Neurological Science, Walton Centre for Neurology & Neurosurgery, Liverpool, UK.
Neurology. 1994 Nov;44(11 Suppl 8):S24-8.
In clinical practice, clinicians use patients' views of treatment when making decisions about management. In clinical trials, however, the patient's perspective is largely ignored, and there has been a preference for "objective" measurements. It is important that clinical trials reflect clinical practice and are clinically relevant; thus, there is a need to include broader-based patient-assessed outcomes in clinical trials. Quality-of-life assessment has been widely applied and accepted in other chronic illnesses; however, standard health and quality-of-life measures might be insensitive to the unusual disabilities produced by epilepsy. A quality-of-life model has been used in order to develop novel measures of seizure severity, impact of epilepsy, and life fulfillment. These scales might add to the sensitivity of clinical trials of new antiepileptic drugs. This approach has been used in a study of lamotrigine and indicates that the drug has some positive effects on seizure severity, in addition to improving quality of life.
在临床实践中，临床医生在做出管理决策时会考虑患者对治疗的看法。然而，在临床试验中，患者的观点在很大程度上被忽视了，人们更倾向于“客观”测量。临床试验反映临床实践并具有临床相关性是很重要的；因此，有必要在临床试验中纳入更广泛的患者评估结果。生活质量评估已在其他慢性疾病中广泛应用并被接受；然而，标准的健康和生活质量测量方法可能对癫痫所导致的特殊残疾不敏感。为了开发癫痫发作严重程度、癫痫影响及生活满意度的新测量方法，采用了一种生活质量模型。这些量表可能会提高新型抗癫痫药物临床试验的敏感性。这种方法已用于一项关于拉莫三嗪的研究，结果表明该药物除了能改善生活质量外，对癫痫发作严重程度也有一些积极作用。
