Gawel M J, Szalai J F, Stiglick A, Aimola N, Weiner M
Department of Neurology, Sunnybrook Medical Center, University of Toronto, Ontario, Canada.
Clin Pharmacol Ther. 1990 Apr;47(4):504-8. doi: 10.1038/clpt.1990.64.
The efficacy of three preparations (placebo, analgesic agent, and analgesic plus antihistaminic agent) were compared in a double-blind crossover study in subjects with recurring headaches. It was confirmed that headache as a pain model does not show the usual return of pain with as the effects of a single analgesic dose wear off. Consequently, there is no "peak effect," and the rationale for comparing treatments by "area under the curve" calculations is weakened. Greater efficacy was demonstrated for the analgesic over the placebo and for the analgesic and antihistaminic combined over the analgesic alone in several parameters. Slopes of straight lines derived as a quadratic function of pain versus time data proved to be a more effective discriminator between treatments than area under the curve calculations from the same data.
在一项针对复发性头痛患者的双盲交叉研究中，比较了三种制剂（安慰剂、镇痛药以及镇痛药加抗组胺药）的疗效。结果证实，作为一种疼痛模型，头痛并不会随着单次镇痛剂量效果的消退而出现通常的疼痛复发。因此，不存在“峰值效应”，通过“曲线下面积”计算来比较治疗效果的理论依据也被削弱。在几个参数方面，已证明镇痛药比安慰剂更有效，且镇痛药与抗组胺药联合使用比单独使用镇痛药更有效。从疼痛与时间数据的二次函数得出的直线斜率，被证明是比从相同数据计算曲线下面积更有效的治疗效果区分指标。
