Sellier P, Audouin P, Payen B, Duong T C, Ourbak P
Presse Med. 1986 Oct 16;15(35):1771-4.
The effects on exercise capacity of a single oral dose of 60 mg of trimetazidine were studied during a double-blind, placebo controlled cross-over study. Ten patients with stable angina and angiographically proven coronary artery lesions underwent ergometric bicycle exercise tests before and two hours after administration of the drug. A blood sample, for trimetazidine levels, was taken at the end of the recovery period. The homogeneity of the group and the lack of significance of the order of administration were established by cross-over analysis of the "control" tests and the "treated" tests. As compared with placebo, a statistically significant difference was noted after trimetazidine in the following parameters: total work (+31%, P less than 0.02), duration of exercise (+17%, P less than 0.02), percentage of the predicted maximal heart rate reached (+4%, P = 0.05), time to 1 mm ST segment depression (+17%, P less than 0.05) and degree of ST depression at maximum exercise level of the first control test (-31%, P less than 0.05); there was no significant difference in heart rate, blood pressure at rest and rate-pressure product during exercise between treatment and placebo. Two patients showed no response to trimetazidine. In the eight patients who did respond, there was a correlation factor of 0.73 between the plasma levels of trimetazidine and the increase in work performed. In conclusion, a single 60 mg dose of trimetazidine improves exercise tolerance and delays the ischaemic threshold during exercise without any detectable peripheral haemodynamic effects.
在一项双盲、安慰剂对照的交叉研究中,研究了单次口服60毫克曲美他嗪对运动能力的影响。10名患有稳定型心绞痛且经血管造影证实有冠状动脉病变的患者在服用药物前和服药两小时后进行了测力计自行车运动测试。在恢复期结束时采集血样以检测曲美他嗪水平。通过对“对照”测试和“治疗”测试的交叉分析确定了组的同质性以及给药顺序的无显著性。与安慰剂相比,服用曲美他嗪后在以下参数上有统计学显著差异:总功(增加31%,P<0.02)、运动持续时间(增加17%,P<0.02)、达到预测最大心率的百分比(增加4%,P = 0.05)、出现1毫米ST段压低的时间(增加17%,P<0.05)以及第一次对照测试最大运动水平时的ST段压低程度(降低31%,P<0.05);治疗组和安慰剂组之间在心率、静息血压和运动期间的速率-压力乘积方面无显著差异。两名患者对曲美他嗪无反应。在有反应的8名患者中,曲美他嗪血浆水平与做功增加之间的相关系数为0.73。总之,单次60毫克剂量的曲美他嗪可提高运动耐量并延迟运动期间的缺血阈值,且无任何可检测到的外周血流动力学影响。