Lagioia R, Scrutinio D, Mangini S G, Mastropasqua F, Caporale R, Mancini G, Loliva F, Rizzon P
Cardiologia. 1989 Feb;34(2):155-60.
This double-blind randomized placebo-controlled study was designed to evaluate the acute effects of orally administered slow-release isosorbide-5-mononitrate (SR IS-5-MN) in 12 patients with chronic stable angina. After a prestudy screening to assess the reproducibility of exercise response, the patients entered the study lasting 5 days. On the first and fourth day of the trial, each patient underwent a bicycle exercise test 4, 8 and 24 hours after acute administration of SR IS-5-MN 50 mg or placebo. Statistic analysis of the results was performed using a 2-way analysis of variance for cross-over design. Compared to placebo, 4 hours after administration, SR IS-5-MN prolonged the exercise time from 525 +/- 162 s to 685 +/- 207 s (p less than 0.05; 30%) and - 1mm time from 437 +/- 147 s to 562 +/- 219 (p less than 0.05; 29%). After 8 hours SR IS-5-MN prolonged the exercise time from 510 +/- 145 s to 615 +/- 189 s (p:ns; 21%), and - 1mm time from 415 +/- 128 s to 522 +/- 205 s (p less than 0.05; 26%). No significant changes were observed 24 hours after SR IS-5-MN administration. The maximal rate-pressure product was significantly increased by SR IS-5-MN 4 hours after administration.(ABSTRACT TRUNCATED AT 250 WORDS)
这项双盲随机安慰剂对照研究旨在评估口服缓释单硝酸异山梨酯（SR IS-5-MN）对12例慢性稳定型心绞痛患者的急性作用。在进行预研究筛查以评估运动反应的可重复性后，患者进入为期5天的研究。在试验的第一天和第四天，每位患者在急性服用50 mg SR IS-5-MN或安慰剂后4、8和24小时进行自行车运动试验。使用双向方差分析对交叉设计的结果进行统计分析。与安慰剂相比，给药后4小时，SR IS-5-MN将运动时间从525±162秒延长至685±207秒（p<0.05；30%），-1mm时间从437±147秒延长至562±219秒（p<0.05；29%）。8小时后，SR IS-5-MN将运动时间从510±145秒延长至615±189秒（p：无显著性差异；21%），-1mm时间从415±128秒延长至522±205秒（p<0.05；26%）。SR IS-5-MN给药24小时后未观察到显著变化。给药后4小时，SR IS-5-MN使最大心率血压乘积显著增加。（摘要截断于250字）
