Loskot F, Novotny P, Sucic P, Schneider G
Herz- und Kreislaufzentrum Rotenburg a. d. F.
Z Kardiol. 1989;78 Suppl 5:89-93.
The aim of this randomized double-blind crossover trial was to evaluate the therapeutic efficacy of 100 mg slow-release gallopamil compared to placebo. The results of multistage exercise tests with computer-assisted ECG were analyzed in 16 patients (14 men and two women) aged 39 to 66 years who fulfilled the angiographical evidence of coronary heart disease with stable angina pectoris. All cardioactive medication was withdrawn for the duration of the study except for the trial medication and sublingual nitroglycerin as required. Patients began the therapy with a 5-day placebo run-in period. After this regimen, they were randomized to placebo or slow-release gallopamil (200 mg/day) in two divided doses for 7 days, at the end of which time each patient crossed over to the alternate regimen. Exercise testing was repeated at the end of the run-in period and after 1 week of placebo or active drug therapy. At highest comparable load the ST-segment depression was reduced about 70% before the morning administration (i.e., 12 h after the evening administration) and 6 h after the morning administration. The work load (W x min) increased in 54% or 61% at the maximal possible load. The number of angina pectoris attacks under bicycle ergometer exercise decreased in about 50%. PR-interval was prolonged from 0.14 to 0.15 s. QRS- and OTc-intervals were not influenced. No clinically relevant changes in heart rate and blood pressure were observed. The results indicate great antianginal efficacy and a good toleration of slow-released gallopamil.
这项随机双盲交叉试验的目的是评估100毫克缓释维拉帕米与安慰剂相比的治疗效果。对16例年龄在39至66岁之间、经血管造影证实患有稳定型心绞痛冠心病的患者(14名男性和2名女性)进行了计算机辅助心电图多阶段运动试验结果分析。在研究期间,除试验药物和必要时的舌下硝酸甘油外,停用所有心血管活性药物。患者开始接受为期5天的安慰剂导入期治疗。在此方案之后,他们被随机分为接受安慰剂或缓释维拉帕米(200毫克/天),分两次服用,为期7天,在此之后,每位患者交叉接受替代方案。在导入期结束时以及接受安慰剂或活性药物治疗1周后重复进行运动试验。在最高可比负荷下,ST段压低在早晨给药前(即晚上给药后12小时)和早晨给药后6小时降低了约70%。在最大可能负荷下,工作量(W×分钟)增加了54%或61%。自行车测力计运动下的心绞痛发作次数减少了约50%。PR间期从0.14秒延长至0.15秒。QRS间期和OTc间期未受影响。未观察到心率和血压的临床相关变化。结果表明缓释维拉帕米具有显著的抗心绞痛疗效和良好的耐受性。