Traisnel G, Lablanche J M, Traisnel-Belbenoit V, Currien D, Darragon T, Fourrier J L, Bertrand M E
Arch Mal Coeur Vaiss. 1986 Dec;79(13):1932-8.
A controlled (placebo) double blind trial of a 20 cm2 transdermal system delivering 10 mg of Trinitrin per 24 hours, was carried out in 18 patients with stable angina and significant coronary artery disease. The exercise stress tests were performed at the same time of day using Bruce's protocol and computerised analysis (Case Marquette) after a 48 hour wash out period. All patients had two basal positive and reproducible exercise tests interrupted because of induced anginal pain and/or greater than or equal to 3.5 mm ST depression. There was no significant difference between the basal exercise stress tests and those performed after placebo. With the active drug the onset of ischaemia was delayed (ST less than -1 mm = 217 +/- 122 sec vs 150 +/- 70 sec with placebo, p less than 0.01); the duration of exercise was prolonged (419 +/- 119 sec vs 328 +/- 94 sec with placebo, p less than 0.01); for the same theoretical maximal heart rate, the ST depression was less (-1.6 +/- 0.9 mm vs -2.1 +/- 0.7 mm with placebo, p less than 0.01). On the other hand, the double rate pressure product was unchanged at rest and on effort. These results obtained after a 48 hour therapeutic window show statistically significant benefits with an increase in exercise tolerance and a decrease in myocardial ischaemia 8 hours after the application of transdermal Trinitrin system.
对18例稳定型心绞痛且患有严重冠状动脉疾病的患者进行了一项对照(安慰剂)双盲试验,该试验使用一种每24小时释放10毫克三硝酸甘油的20平方厘米透皮系统。在48小时的洗脱期后,使用布鲁斯方案和计算机分析(Case Marquette)在一天中的同一时间进行运动应激试验。所有患者均进行了两次基础阳性且可重复的运动试验,但均因诱发心绞痛和/或ST段压低大于或等于3.5毫米而中断。基础运动应激试验与服用安慰剂后的试验之间无显著差异。使用活性药物后,缺血发作延迟(ST段小于-1毫米:与安慰剂组的150±70秒相比,为217±122秒,p<0.01);运动持续时间延长(与安慰剂组的328±94秒相比,为419±119秒,p<0.01);在相同的理论最大心率下,ST段压低程度减轻(与安慰剂组的-2.1±0.7毫米相比,为-1.6±0.9毫米,p<0.01)。另一方面,静息和运动时的双率压力乘积没有变化。在48小时治疗窗口后获得的这些结果显示,使用透皮三硝酸甘油系统8小时后,运动耐量增加,心肌缺血减少,具有统计学上的显著益处。