Passeron J
Presse Med. 1986 Oct 16;15(35):1775-8.
The antianginal activity of trimetazidine (Vastarel 20 mg) was evaluated in a double blind study versus placebo. The 54 subjects of the survey were males, of mean age 55.2 +/- 1.4 years in the trimetazidine group and 55.5 +/- 1.8 years in the placebo group, suffering from stable angina. The stability of angina was tested by two exercise tests carried out at the beginning and at the end of a two-week preselection period under placebo. Three tablets daily of either trimetazidine or placebo were given at random for two weeks. At the end of that time, a third exercise test was carried out. The clinical results showed a significant reduction (P less than 0.001) in the number of weekly attacks from 8.1 +/- 0.3 to 2.9 +/- 0.5 under trimetazidine and from 7.6 +/- 0.2 to 4.9 +/- 0.5 under placebo. Moreover, nitroglycerin consumption over a week decreased from 9.1 +/- 0.6 to 3.1 +/- 0.5 tablets under trimetazidine and from 7.9 +/- 0.3 to 5.4 +/- 0.6 tablets under placebo. The difference was significant (P less than 0.001). The global evaluation of the exercise tests showed a significant difference in favor of trimetazidine: 19 patients out of 27 improved under trimetazidine, as compared to 11 out of 27 under placebo. The total workload-capacity after treatment was increased by 62.1% under trimetazidine, and by 24.7% under placebo (P = 0.007). The rate-pressure product diminished by 12% with trimetazidine and by 4% with the placebo. Nevertheless, the interaction was not significant (P = 0.079). This study made it possible to evaluate the significant reduction of stress attacks frequency and nitroglycerin consumption under trimetazidine versus placebo. This clinical improvement was assessed by ergometric parameters.
在一项与安慰剂对照的双盲研究中，评估了曲美他嗪（万爽力20毫克）的抗心绞痛活性。该调查的54名受试者均为男性，曲美他嗪组的平均年龄为55.2±1.4岁，安慰剂组为55.5±1.8岁，均患有稳定型心绞痛。在安慰剂治疗的两周预选期开始和结束时，通过两次运动试验来测试心绞痛的稳定性。随机给予曲美他嗪或安慰剂每日三片，持续两周。在该时间段结束时，进行第三次运动试验。临床结果显示，曲美他嗪治疗后每周发作次数从8.1±0.3显著减少至2.9±0.5（P<0.001），安慰剂治疗后从7.6±0.2减少至4.9±0.5。此外，曲美他嗪治疗一周内硝酸甘油的消耗量从9.1±0.6片减少至3.1±0.5片，安慰剂治疗后从7.9±0.3片减少至5.4±0.6片。差异具有显著性（P<0.001）。运动试验的总体评估显示，曲美他嗪组有显著优势：曲美他嗪组27名患者中有19名病情改善，而安慰剂组27名患者中有11名改善。曲美他嗪治疗后总工作量能力增加了62.1%，安慰剂治疗后增加了24.7%（P=0.007）。曲美他嗪使心率血压乘积降低了12%，安慰剂使其降低了4%。然而，交互作用不显著（P=0.079）。该研究使得评估曲美他嗪与安慰剂相比在显著降低应激发作频率和硝酸甘油消耗量方面成为可能。这种临床改善通过测力计参数进行评估。
