Olesen J, Krabbe A A, Tfelt-Hansen P
Cephalalgia. 1981 Sep;1(3):127-41. doi: 10.1046/j.1468-2982.1981.0103127.x.
The purpose of this paper is to analyse methodological aspects of prophylactic drug trials in migraine. A study of ferrum quartz in 33 patients provided the necessary data base. Migraine definitions, relation between interval headache and migraine, and a number of other clinical problems are discussed. A headache diary is presented which to a certain extent allows a separation of internal headache and migraine attacks. Virtually all patients with frequent migraine attacks have interval headaches. A statistical model which allows a separation of time effects and treatment effects is presented. The inter-patient variability was much greater than intra-patient variability. This indicates that it will be difficult to obtain sufficient power with a non-crossover design. The relation between duration of treatment periods and the necessary number of patients is shown to be inversely related.
本文旨在分析偏头痛预防性药物试验的方法学方面。对33例患者进行的铁石英研究提供了必要的数据库。讨论了偏头痛的定义、间歇性头痛与偏头痛之间的关系以及其他一些临床问题。提出了一份头痛日记，它在一定程度上可以区分内在性头痛和偏头痛发作。几乎所有频繁发作偏头痛的患者都有间歇性头痛。提出了一种能够区分时间效应和治疗效应的统计模型。患者间的变异性远大于患者内的变异性。这表明采用非交叉设计很难获得足够的检验效能。治疗期时长与所需患者数量之间的关系呈负相关。
