The aim of the study was to introduce the feasibility and utility of clinical trial simulation as applied to the clinical development of naratriptan. The probability of pain relief was estimated with the proportional odds model. The result was very close with the curve from the instruction. Clinical trial simulation resulted in a design with seven arms at 0, 1,2.5,5, 10, 15 and 20 mg. The curve of headache relief probability expressed pain relief trend directly with the change of dose, which gave a reference to the dose of naratriptan on the clinical trial. Clinical trial simulation is a useful tool for the quantitative assessment of the influence of the controllable factors.%以那拉曲坦为例,基于比例优势模型验证了药物临床计算机模拟的可行性和实用性.对疼痛减轻的概率预测,得到的结果与那拉曲坦说明书中的曲线十分接近.在给药方案为安慰剂1、2.5、5、10、15、20mg情况下,得出头痛减轻概率的曲线,得到头痛减轻概率随给药剂量的不同而变化,从而对临床给药方案提供一定的参考.药物临床的计算机模拟是可控因素影响下定量分析的有效方法.
展开▼
