O'Keefe J C, Creamer J E, Banim S O
Clin Cardiol. 1987 Jun;10(6):345-50. doi: 10.1002/clc.4960100609.
A double-blind, placebo-controlled study was performed to assess whether a new calcium antagonist, nisoldipine, in doses of either 5 mg or 10 mg daily, in combination with beta-adrenergic-blocking drugs (combination therapy) was more effective than beta-adrenergic-blocking drugs alone (single therapy) in the treatment of chronic stable angina. Treatments were assessed at two-week intervals, using exercise electrocardiography and patients' anginal diaries. A significant improvement in exercise capacity and reduction in anginal attacks occurred only during nisoldipine (10 mg daily) combination therapy compared with single therapy. Mean exercise time increased from 419 +/- 146 s (single) to 454 +/- 158 s (p less than 0.02) after combination therapy. Exercise time to onset of 1 mm ST-segment depression improved from 326 +/- 145 s (single) to 331 +/- 139 s after combination therapy, although the change was not significant. Mean number of anginal attacks decreased from 21 +/- 22 (single to 15 +/- 19 (p less than 0.01) during combination treatment, with an associated significant reduction in glyceryl trinitrate consumption. Adverse effects during combined therapy were minor and tolerable. Thus patients limited by exertional angina despite beta-adrenergic-blocking drugs may obtain supplemental relief of angina and myocardial ischemia with the addition of nisoldipine in a dose of 10 mg daily.
进行了一项双盲、安慰剂对照研究,以评估一种新的钙拮抗剂尼索地平,每日剂量为5毫克或10毫克,与β-肾上腺素能阻滞剂联合使用(联合治疗)是否比单独使用β-肾上腺素能阻滞剂(单一治疗)在治疗慢性稳定型心绞痛方面更有效。每隔两周使用运动心电图和患者心绞痛日记对治疗效果进行评估。与单一治疗相比,仅在尼索地平(每日10毫克)联合治疗期间运动能力有显著改善,心绞痛发作次数减少。联合治疗后平均运动时间从419±146秒(单一治疗)增加到454±158秒(P<0.02)。联合治疗后运动至ST段压低1毫米开始的时间从326±145秒(单一治疗)改善到331±139秒,尽管变化不显著。联合治疗期间心绞痛发作的平均次数从21±22次(单一治疗)降至15±19次(P<0.01),同时硝酸甘油消耗量显著减少。联合治疗期间的不良反应轻微且可耐受。因此,尽管使用了β-肾上腺素能阻滞剂但仍受劳力性心绞痛限制的患者,每日加用10毫克尼索地平可能会额外缓解心绞痛和心肌缺血。