Randomized, double-blind comparison of propranolol alone and a propranolol-verapamil combination in patients with severe angina of effort.
Randomized, double-blind comparison of propranolol alone and a propranolol-verapamil combination in patients with severe angina of effort.
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单独使用普萘洛尔和普萘洛尔-维拉帕米组合治疗严重劳力性心绞痛患者的随机、双盲比较。
DOI：
10.1016/s0735-1097(83)80078-3
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发表时间：
1983
影响因子：
24
通讯作者：
Hillis,LD
中科院分区：
文献类型：
--
作者：
Winniford,MD;Huxley,RL;Hillis,LD
本研究比较了普萘洛尔单用与普萘洛尔和维拉帕米联合治疗严重限制性心绞痛患者的疗效。因此，13名患有严重心绞痛的男性（平均年龄57岁）参加了为期7周的研究。在整个研究期间，给予普萘洛尔稳定剂量（295 ± 83 [平均值±标准差] mg/天）。除普萘洛尔治疗外，每例患者接受2周的开放标签维拉帕米上调，1周的维拉帕米下调和两个2周的随机双盲治疗，一个安慰剂治疗，另一个维拉帕米治疗（431 ± 77 mg/天）。普萘洛尔-维拉帕米联合用药导致心绞痛发作/周（普萘洛尔-安慰剂组7.3 ± 6.9/周，普萘洛尔-维拉帕米组4.7 ± 5.0/周，p = 0.03）和硝酸甘油片使用/周（普萘洛尔-安慰剂组7.6 ± 6.6/周，普萘洛尔-维拉帕米组4.4 ± 4.2/周，p = 0.008）下降。普萘洛尔-安慰剂组，所有13例患者在仰卧位自行车运动4.6 ±2.1分钟后发生心绞痛。使用普萘洛尔-维拉帕米，5名患者即使运动持续时间增加也没有心绞痛;在其他8个病例中，（从普萘洛尔-安慰剂组的4.0 ±1.5分钟到普萘洛尔-维拉帕米组的5.3 ± 1.6分钟，p = 0.01）。普萘洛尔-维拉帕米联合用药未引起静息或运动峰值左心室容积或射血分数的变化（通过平衡门控血池造影评估）。使用普萘洛尔-维拉帕米，4例患者PR间期延长，2例患者出现疲劳和呼吸困难。此外，2例患者出现明显窦性心动过缓伴交界性逸搏心律，经减少维拉帕米剂量后缓解。无一例发生充血性心力衰竭或高度房室传导阻滞。因此，普萘洛尔和维拉帕米的组合是上级优于普萘洛尔单独在严重的，限制性心绞痛患者，但这种组合必须谨慎使用，因为潜在的严重不良反应。
This study compared propranolol alone with a combination of propranolol and verapamil in patients with severe, limiting angina of effort. Accordingly, 13 men (average age 57 years) with severe angina were enrolled in a study of 7 weeks' duration. Throughout the study, a stable dose of propranolol (295 ± 83 [mean ± standard deviation] mg/day) was administered. In addition to propranolol therapy, each patient was given 2 weeks of up-titration of open label verapamil, 1 week of verapamil down-titration and two 2 week periods of randomized, double-blind therapy, one of placebo and the other of verapamil (431 ± 77 mg/day). A propranolol-verapamil combination caused a decline in anginal episodes/ week (7.3 ± 6.9/week during propranolol-placebo, 4.7 ± 5.0/week during propranolol-verapamil, p = 0.03) and nitroglycerin tablets used/week (7.6 ± 6.6/week during propranolol-placebo, 4.4 ± 4.2/week during propranolol-verapamil, p = 0.008). With propranolol-placebo, all 13 patients had angina after 4.6 ±2.1 minutes of supine bicycle exercise. With propranolol-verapamil, five had no angina with exercise even though their duration of exercise increased; in the other eight, time to angina increased (from 4.0 ±1.5 minutes with propranolol-placebo to 5.3 ± 1.6 minutes with propranolol-verapamil, p = 0.01).A propranolol-verapamil combination induced no change in rest or peak exercise left ventricular volumes or ejection fraction (assessed by equilibrium gated blood pool scintigraphy). With propranolol-verapamil, four patients had PR interval prolongation, and two had fatigue and dyspnea. In addition, two had marked sinus bradycardia with junctional escape rhythm that was resolved with a reduction of verapamil dosage. No patient developed congestive heart failure or high degree atrioventricular block. Thus, a combination of propranolol and verapamil is superior to propranolol alone in patients with severe, limiting angina, but such a combination must be used cautiously because of potentially serious adverse effects.