Carboni G P, Saltarocchi M L, Risa A L, Scardovi A B, Zanchi E, Prati P L
Divisione Cardiologia A, Ospedale S. Camillo, Roma, Italy.
J Cardiovasc Pharmacol. 1992;20 Suppl 7:S64-70.
The efficacy of combining gallopamil and isosorbide-5-mononitrate (IS-5-MN) was evaluated in 15 patients with "mixed" angina and documented coronary artery disease who participated in a 4-week, double-blind, double-dummy, crossover, placebo-controlled trial. After the first week of the placebo phase (single-blinded), all patients received in three different weeks IS-5-MN 20 mg three times daily, gallopamil 50 mg three times daily, and the same dosages of IS-5-MN and gallopamil three times daily. Exercise tolerance, and peak values of heart rate, systolic blood pressure, double product (DP/100), and ST-segment were evaluated with a treadmill test at the end of each phase. The improvement in exercise tolerance obtained by the combination of the two drugs was significantly greater (p < 0.01) than that achieved by IS-5-MN but not that by gallopamil monotherapy (NS). This effect was accompanied by significant (p < 0.05) reduction (-61%) in ST-segment and significant (p < 0.05) increment (+8%) in peak heart rate only after administration of the combination of the two drugs. The number of ST-depression (ST-) > 1 mm or ST-elevation (ST+) episodes on 24-h Holter monitoring lasting > or = 1 min were also noted in all patients at the end of each phase of the trial.(ABSTRACT TRUNCATED AT 250 WORDS)
在15例患有“混合型”心绞痛且有冠状动脉疾病记录的患者中,评估了加洛帕米与5-单硝酸异山梨酯(IS-5-MN)联合用药的疗效。这些患者参与了一项为期4周的双盲、双模拟、交叉、安慰剂对照试验。在安慰剂阶段(单盲)的第一周后,所有患者在三个不同的周分别接受每日三次、每次20mg的IS-5-MN,每日三次、每次50mg的加洛帕米,以及每日三次相同剂量的IS-5-MN和加洛帕米。在每个阶段结束时,通过跑步机试验评估运动耐量、心率峰值、收缩压、双乘积(DP/100)和ST段。两种药物联合使用所获得的运动耐量改善显著大于(p<0.01)IS-5-MN单独使用时,但并不大于加洛帕米单药治疗时(无显著性差异)。仅在两种药物联合给药后,这种效果伴随着ST段显著(p<0.05)降低(-61%)和心率峰值显著(p<0.05)升高(+8%)。在试验每个阶段结束时,还记录了所有患者24小时动态心电图监测中持续≥1分钟的ST段压低(ST-)>1mm或ST段抬高(ST+)发作的次数。(摘要截短于250字)