Klein W, Brandt D, Fluch N, Maurer E
Z Kardiol. 1982 Jun;71(6):398-405.
In a placebo-controlled, randomized double-blind study, 43 out-patients with stable angina pectoris were treated for 2 months with a calcium-antagonist. 9 patients received a constant dose of 60 mg diltiazem t.i.d.; 12 patients underwent a dose increase to 90 mg t.i.d. after 4 weeks of treatment because of insufficient therapy response. In 5 patients 10 mg nifedipine t.i.d. was sufficient, 17 patients received 20 mg t.i.d. during the second part of the study. The patients were examined and subjected to symptom-limited ergometric tests at 2-week intervals. Under both medications, the frequency of anginal attacks decreased significantly; this was accompanied by a concomitant decrease of nitroglycerin consumption. During the tests, the time to occurrence of anginal complaints and thereby work capacity increased. ST-depression and ST-index were diminished. Heart rate, blood pressure and pressure-rate product did not change at rest or under exercise. There was no statistically significant difference between the two calcium-antagonists. Patients who showed satisfactory results under one of the two medications participated in an open, uncontrolled long-term trial and were treated with 60 mg or 90 mg diltiazem t.i.d. over a one-year period. There were no clinically remarkable events on changing from nifedipine to diltiazem. The monthly controls and the quarterly ergometric tests showed an unchanged efficacy of diltiazem. During the double-blind short-term treatment, the frequency of side effects was slightly lower under diltiazem than under nifedipine. Long-term treatment especially confirms the good tolerance of diltiazem.
在一项安慰剂对照的随机双盲研究中,43例稳定型心绞痛门诊患者接受了钙拮抗剂治疗2个月。9例患者每日3次服用60毫克地尔硫䓬的恒定剂量;12例患者在治疗4周后因治疗反应不足,剂量增加至每日3次90毫克。5例患者每日3次服用10毫克硝苯地平就足够了,17例患者在研究的第二阶段每日3次服用20毫克。患者每隔2周接受检查并进行症状限制运动试验。在两种药物治疗下,心绞痛发作频率均显著降低;同时硝酸甘油消耗量也随之减少。在试验期间,心绞痛症状出现的时间以及工作能力均有所增加。ST段压低和ST指数降低。静息或运动时心率、血压和压力-心率乘积均未改变。两种钙拮抗剂之间无统计学显著差异。在两种药物之一治疗下显示出满意结果的患者参加了一项开放、非对照的长期试验,并在一年时间内每日3次服用60毫克或90毫克地尔硫䓬。从硝苯地平换用地尔硫䓬时未发生临床上显著的事件。每月的检查和每季度的运动试验显示地尔硫䓬的疗效不变。在双盲短期治疗期间,地尔硫䓬组的副作用发生率略低于硝苯地平组。长期治疗尤其证实了地尔硫䓬具有良好的耐受性。