Crean P A, Ribeiro P, Crea F, Davies G J, Ratcliffe D, Maseri A
Am Heart J. 1984 Dec;108(6):1494-500. doi: 10.1016/0002-8703(84)90697-5.
We assessed the effect of transdermal nitroglycerin (NTG-TTS), releasing 5 mg/24 hr, in 11 patients with chronic stable angina during a randomized, placebo-controlled, double-blind, double crossover trial of four 1-week periods. All patients had a positive exercise test and coronary artery disease prior to entry into the study. Efficacy was assessed weekly by anginal diaries, ambulatory ST segment recordings, and computerized exercise testing 2 to 4 hours after renewal of NTG-TTS. One patient withdrew in the first week (placebo) and was excluded from all analysis. The weekly frequency of anginal attacks was 9 +/- 11 (mean +/- SD) and 9 +/- 10 during the 2 placebo weeks and 11 +/- 14 and 9 +/- 11 during NTG-TTS; the time to 1 mm ST segment depression (seconds) was 268 +/- 178 and 303 +/- 217 with placebo and 228 +/- 221 and 285 +/- 178 with NTG-TTS; exercise duration (seconds) was 375 +/- 230 and 467 +/- 254 during placebo and was 394 +/- 233 and 412 +/- 236 during NTG-TTS. The weekly number of episodes of ST depression was 11 +/- 9 and 8 +/- 5 during placebo and 8 +/- 5 and 9 +/- 7 during NTG-TTS. Our study failed to show any consistent differences in patients treated with placebo or NTG-TTS.
在一项为期四周、随机、安慰剂对照、双盲、双交叉试验中,我们评估了每日释放5毫克的经皮硝酸甘油(NTG-TTS)对11例慢性稳定型心绞痛患者的疗效。所有患者在进入研究前运动试验呈阳性且患有冠状动脉疾病。通过心绞痛日记、动态ST段记录以及在更换NTG-TTS后2至4小时进行的计算机化运动试验,每周评估疗效。一名患者在第一周(安慰剂组)退出,被排除在所有分析之外。在两个安慰剂周期间,心绞痛发作的每周频率分别为9±11(平均值±标准差)和9±10,在使用NTG-TTS期间为11±14和9±11;出现1毫米ST段压低的时间(秒)在安慰剂组为268±178和303±217,在NTG-TTS组为228±221和285±178;运动持续时间(秒)在安慰剂组为375±230和467±254,在NTG-TTS组为394±233和412±236。安慰剂组ST段压低发作的每周次数为11±9和8±5,NTG-TTS组为8±5和9±7。我们的研究未能显示出安慰剂组和NTG-TTS组患者之间存在任何一致的差异。