Carù B, Pirelli S, Ferratini M, Gasparini M, Cattafi G, Corrada E, Pollavini P
Department of Cardiology, Centre A. De Gasperis, Ospedale Cà Granda Niguarda, Milano, Italy.
Eur Heart J. 1988 Jan;9 Suppl A:105-11. doi: 10.1093/eurheartj/9.suppl_a.105.
In two randomized, double blind, placebo-controlled, within patient, studies, the effects of 4 doses of a new transdermal therapeutic system containing nitroglycerin (TTS-NTG) were studied in a total of 15 patients with stable exercise-induced angina pectoris. A single 24-hour application of TTS-NTG 10 cm2, TTS-NTG 20 cm2 and TTS placebo (1st study: 6 patients) and of TTS-NTG 40 cm2, TTS-NTG 80 cm2 and TTS placebo (2nd study: 9 patients) was applied on 3 different days, and a symptom-limited cycloergometric exercise test was performed 3, 12 (only in the 2nd study) and 24 hours after the application of each treatment. In comparison with placebo, the doses tested in the 1st study induced, at the 3rd hour post-dosing, a decrease in standing systolic blood pressure and an improvement in exercise tolerance which, however, were not statistically significant while the effects at the 24th hour were similar to those of placebo. In the 2nd study, in comparison with placebo, both TTS-NTG doses induced, 3 hours post-dosing, a significant decrease in both lying and standing systolic (P less than 0.01) blood pressure at rest, and a significant (P less than 0.01) improvement in exercise tolerance throughout the 24 hours of application. It is concluded that, in patients with exercise-induced angina pectoris due to coronary artery disease, a single application of TTS-NTG 40 cm2 or 80 cm2 results in a 24-hour increase in exercise tolerance.
在两项随机、双盲、安慰剂对照、患者自身对照研究中，对一种含硝酸甘油的新型透皮治疗系统（TTS-NTG）的4种剂量进行了研究，共有15例稳定型运动诱发型心绞痛患者参与。在3个不同日期分别单次应用24小时的TTS-NTG 10 cm²、TTS-NTG 20 cm²和TTS安慰剂（第一项研究：6例患者），以及TTS-NTG 40 cm²、TTS-NTG 80 cm²和TTS安慰剂（第二项研究：9例患者），每次治疗应用后3、12小时（仅在第二项研究中）和24小时进行症状限制性运动平板试验。与安慰剂相比，第一项研究中测试的剂量在给药后第3小时导致站立收缩压下降和运动耐量改善，但无统计学意义，而在第24小时的效果与安慰剂相似。在第二项研究中，与安慰剂相比，两种TTS-NTG剂量在给药后3小时均导致静息时卧位和站立位收缩压显著下降（P<0.01），并且在整个24小时的应用过程中运动耐量显著改善（P<0.01）。得出结论，在因冠状动脉疾病导致运动诱发型心绞痛的患者中，单次应用40 cm²或80 cm²的TTS-NTG可使运动耐量提高24小时。
