Harpey C, Coker S, Sellier P, Maccario J, Détry J M
LBF, Scientific Direction, Neuilly-sur-Seine, Belgium.
Fundam Clin Pharmacol. 1996;10(2):151-5. doi: 10.1111/j.1472-8206.1996.tb00158.x.
The comparison of the anti-ischemic activity of trimetazidine and propranolol was evaluated by multiple end points (clinical, exercise test, and ambulatory electrocardiogram [ECG] monitoring criteria) in 149 male patients with effort angina who received either trimetazidine 20 mg tid or propranolol 40 mg tid during a period of 3 months. The distribution of the standardized differences between the two treatments for each variable was obtained by a permutation method. The medians (estimation of the actual difference between the two treatments) and the 5, 25, 75 and 95% quantiles were represented on the same diagram for all end points. The pattern of the standardized distribution of the differences showed a similar activity of both drugs on symptoms and nitrates consumption, on exercise tolerance and increase in ischemic threshold at exercise, and on ischemia recorded at ambulatory ECG monitoring. Conversely, only propranolol decreased heart rate and rate pressure product at rest as well as at exercise, underlining the difference in the mode of action of the two drugs. This descriptive technique is an attractive method to evaluate the differences between drugs considering multiple criteria favouring the estimation of these differences together with their variability.
在149例劳力性心绞痛男性患者中,采用多终点指标(临床症状、运动试验和动态心电图[ECG]监测标准)评估了曲美他嗪和普萘洛尔的抗缺血活性。这些患者在3个月期间接受曲美他嗪20 mg每日三次或普萘洛尔40 mg每日三次治疗。通过置换法获得两种治疗方法在每个变量上标准化差异的分布情况。针对所有终点指标,将中位数(两种治疗方法实际差异的估计值)以及第5、25、75和95百分位数绘制在同一张图表上。差异标准化分布的模式显示,两种药物在症状和硝酸酯类药物消耗、运动耐量和运动时缺血阈值增加以及动态心电图监测记录的缺血方面具有相似的活性。相反,只有普萘洛尔能降低静息和运动时的心率及心率血压乘积,这突出了两种药物作用方式的差异。这种描述性技术是一种有吸引力的方法,可在考虑多个标准的情况下评估药物之间的差异,有助于同时估计这些差异及其变异性。