Reiniger G, Rudolph W
Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum, München.
Herz. 1987 Oct;12(5):348-53.
In ten patients with angiographically-documented coronary artery disease, according to a double-blind, placebo-controlled protocol, the antiischemic and antianginal actions of a new transdermal nitroglycerin patch system with discontinuous drug release (7.5 mg/24 hours, two-thirds of which is released within the first twelve hours) were assessed on three consecutive days to determine whether effective longterm treatment is possible (Figure 1). At 2.5 hours after initial application, as compared with placebo, the active drug led to a reduction in exercise-induced ST-segment depression of 55.9% (p less than 0.001; Figure 2), the exercise capacity to onset of 1 mm ST-segment depression increased 129% (p less than 0.05; Figure 3), angina pectoris during exercise was incurred in only 20% of the patients (Figure 4). At twelve hours, the corresponding effects were attenuated at -44%, +114% and +60%. 24 hours after patch application, an appreciable effect could no longer be detected. After renewed patch application on the second day, as compared with the initial application, the actions on ST-segment depression and exercise capacity were diminished about 20%. Similarly, there was an increase in the number of patients who developed angina during exercise. At twelve hours, there was more marked attenuation of the effects on all three parameters than that which had already been observed on the first day. At 24 hours, there were no significant effects. At 2.5 hours after renewed patch application on the third day, the effects on ST-segment depression, exercise capacity and incurrence of angina pectoris were essentially similar those seen after the second application.(ABSTRACT TRUNCATED AT 250 WORDS)
在10例经血管造影证实患有冠状动脉疾病的患者中,按照双盲、安慰剂对照方案,连续三天评估一种新的具有间断性药物释放功能的经皮硝酸甘油贴片系统(7.5毫克/24小时,其中三分之二在前12小时内释放)的抗缺血和抗心绞痛作用,以确定是否可能进行有效的长期治疗(图1)。首次应用后2.5小时,与安慰剂相比,活性药物使运动诱发的ST段压低降低了55.9%(p<0.001;图2),运动至出现1毫米ST段压低的能力增加了129%(p<0.05;图3),运动期间仅20%的患者发生心绞痛(图4)。12小时时,相应效果分别减弱至-44%、+114%和+60%。贴片应用24小时后,不再能检测到明显效果。第二天重新贴片应用后,与首次应用相比,对ST段压低和运动能力的作用降低了约20%。同样,运动期间发生心绞痛的患者数量有所增加。12小时时,对所有三个参数的作用减弱程度比第一天观察到的更为明显。24小时时,无显著效果。第三天重新贴片应用后2.5小时,对ST段压低、运动能力和心绞痛发生情况的作用与第二次应用后基本相似。(摘要截断于250字)