Molinero De Miguel E, Salcedo Arruti A, Sagastagoitia Gorostiza J D, Iriarte Ezkurdia M M, Fernandez Vidal P, Velasco Quintana J, Garrido García J
Hospital Civil de Basurto, Bilbao, Spain.
Int J Cardiol. 1993 Jul 1;40(2):127-33. doi: 10.1016/0167-5273(93)90275-l.
In order to compare the anti-ischemic activity of gallopamil and nifedipine, a cross-over, double-blind, randomised trial was carried out in 30 male out-patients with a history of stable exertional angina, proven coronary disease and a positive stress test (ST-segment depression > or = 1 mm). After a first 1-week wash-out period on placebo, the patients were randomised to gallopamil, 150 mg/day (50, 50 and 50) or nifedipine, 30 mg/day (10, 10 and 10) for 28 days. After a second 1-week wash-out period active treatments were crossed for another 28 days. At the end of each drug or placebo period, a physical examination, laboratory tests and a stress test were performed. Oral short-acting nitrates were permitted throughout the trial periods. Twenty-one patients finished all periods of the study. Both drugs reduced the maximum ST-segment depression during the exercise test: from 2.45 +/- 0.97 mm (placebo) to 1.95 +/- 0.82 mm (gallopamil, P < 0.05) and from 2.50 +/- 0.93 mm (placebo) to 1.75 +/- 0.84 mm (nifedipine, P < 0.05). Gallopamil but not nifedipine increased stress tolerance significantly: from 486 +/- 156 s (placebo) to 598 +/- 138 s (gallopamil, P < 0.05) and from 509 +/- 113 s (placebo) to 567 +/- 191 s (nifedipine, NS). No significant differences were found between drugs. Both calcium antagonists, gallopamil and nifedipine, showed similar efficacy in treating myocardial ischemia.
为比较加洛帕米和硝苯地平的抗缺血活性,对30例有稳定劳力性心绞痛病史、确诊冠心病且运动试验阳性(ST段压低≥1mm)的男性门诊患者进行了一项交叉、双盲、随机试验。在安慰剂洗脱1周后,患者被随机分为加洛帕米组,150mg/天(50、50和50)或硝苯地平组,30mg/天(10、10和10),为期28天。在第二个1周洗脱期后,进行28天的交叉活性治疗。在每个药物或安慰剂治疗期结束时,进行体格检查、实验室检查和运动试验。整个试验期间允许口服短效硝酸盐。21例患者完成了研究的所有阶段。两种药物均降低了运动试验期间的最大ST段压低:从2.45±0.97mm(安慰剂)降至1.95±0.82mm(加洛帕米,P<0.05),从2.50±0.93mm(安慰剂)降至1.75±0.84mm(硝苯地平,P<0.05)。加洛帕米显著提高了运动耐量,但硝苯地平未显著提高:从486±156秒(安慰剂)增至598±138秒(加洛帕米,P<0.05),从509±113秒(安慰剂)增至567±191秒(硝苯地平,无显著性差异)。两种药物之间未发现显著差异。加洛帕米和硝苯地平这两种钙拮抗剂在治疗心肌缺血方面显示出相似的疗效。