Almenar L, Gimeno J V, Sotillo J, Moreno M T, Salvador A, Miró V, Mora V, Martínez Dolz L, Algarra F
Servicio de Cardiología, Hospital La Fe, Valencia.
Rev Esp Cardiol. 1993 May;46(5):298-303.
The aim for this study was to evaluate the hemodynamic changes that appear in patients with myocardiopathy at functional stage II (NYHA) subjected to standard treatment (digital+diuretics) plus nitrates. We used isosorbide-5-mononitrate (IS-5-MN). We studied 20 patients for 100 days in different phases. The placebo-controlled, crossover, double-blind stage random distribution was from day 2 to 5. From day 6 to 20 all the patients took 40 mg/12 hours of IS-5-MN, taking 40 mg/8 hours of active ingredient from day 21 to 100. We performed basal cycloergometrics 3 and 6 hours after administration on days 2, 5, 20, 34 and 100 of the treatment, as well as echocardiograms on these same days. We compared the results obtained versus placebo (p < 0.05). There were no significant differences in heart rate at rest or systolic arterial tension at rest or maximum. Maximum heart rate increased significantly in the tests at days 34 (basal: 143 +/- 9; 3 hours: 139 +/- 8; 6 hours: 140 +/- 7) and 100 (basal: 145 +/- 7; 3 hours: 141 +/- 8; 6 hours: 142 +/- 6) versus the tests carried out with placebo (basal: 136 +/- 8; 3 hours: 135 +/- 7; 6 hours: 136 +/- 7). There were no differences in the tests after acute dose or at treatment day 20.(ABSTRACT TRUNCATED AT 250 WORDS)
本研究的目的是评估处于II级功能阶段（纽约心脏协会分级）的心肌病患者在接受标准治疗（洋地黄+利尿剂）加硝酸盐治疗时出现的血流动力学变化。我们使用了5-单硝酸异山梨酯（IS-5-MN）。我们在不同阶段对20名患者进行了100天的研究。安慰剂对照、交叉、双盲阶段随机分配从第2天至第5天。从第6天至第20天，所有患者服用40毫克/12小时的IS-5-MN，从第21天至第100天服用40毫克/8小时的活性成分。在治疗的第2、5、20、34和100天给药后3小时和6小时进行基础循环功量计检查，并在同一天进行超声心动图检查。我们将所得结果与安慰剂进行比较（p<0.05）。静息心率、静息或最大收缩动脉压无显著差异。在第34天（基础值：143±9；3小时：139±8；6小时：140±7）和第100天（基础值：145±7；3小时：141±8；6小时：142±6）的测试中，最大心率相对于安慰剂测试（基础值：136±8；3小时：135±7；6小时：136±7）显著增加。急性剂量后或治疗第20天的测试中无差异。（摘要截断于250字）
