Weiner D A, Klein M D, Cutler S S
Am J Cardiol. 1987 Feb 1;59(4):215-8. doi: 10.1016/0002-9149(87)90787-9.
The effectiveness of a sustained-release preparation of verapamil (verapamil-SR) was compared with the regular formulation of verapamil and with placebo in 12 patients with chronic stable angina pectoris. All patients completed an 8-week, double-blind, double-crossover, randomized protocol with 2-week treatment periods of verapamil-SR, 240 mg twice daily; regular-formulation verapamil, 120 mg 4 times daily; and 2 placebo therapies. The frequency of weekly anginal episodes was reduced from 7.6 +/- 10.0 with placebo to 3.1 +/- 4.2 after the regular formulation of verapamil (p = 0.09) and from 6.4 +/- 7.6 with placebo to 2.8 +/- 4.8 after verapamil-SR (p = 0.06). Treadmill time increased from 384 +/- 144 seconds during the first placebo phase to 468 +/- 138 seconds after the regular formulation of verapamil (p less than 0.01) and from 354 +/- 102 seconds during the second placebo phase to 462 +/- 138 seconds after verapamil-SR (p less than 0.01). Time to the onset of angina was similarly prolonged by formulations of verapamil. There were no significant adverse effects after 1 year in any patient taking verapamil-SR, 240 mg twice daily. Thus, a twice-a-day verapamil-SR dose regimen is safe and is as effective for treatment of angina of effort as the regular formulation given 4 times a day.
将维拉帕米缓释制剂(维拉帕米-SR)与维拉帕米常规制剂及安慰剂相比较,研究了其对12例慢性稳定型心绞痛患者的疗效。所有患者均完成了一项为期8周的双盲、双交叉、随机试验方案,其中包括两个为期2周的治疗期,分别使用维拉帕米-SR(每日2次,每次240mg)、常规制剂维拉帕米(每日4次,每次120mg)以及两种安慰剂疗法。每周心绞痛发作频率从安慰剂治疗时的7.6±10.0次,降至维拉帕米常规制剂治疗后的3.1±4.2次(p = 0.09);从安慰剂治疗时的6.4±7.6次,降至维拉帕米-SR治疗后的2.8±4.8次(p = 0.06)。运动平板试验时间从第一个安慰剂阶段的384±144秒,增加至维拉帕米常规制剂治疗后的468±138秒(p<0.01);从第二个安慰剂阶段的354±102秒,增加至维拉帕米-SR治疗后的462±138秒(p<0.01)。维拉帕米制剂同样延长了心绞痛发作时间。在接受每日2次、每次240mg维拉帕米-SR治疗的患者中,1年内未出现显著不良反应。因此,每日2次的维拉帕米-SR给药方案安全有效,治疗劳力性心绞痛的效果与每日4次的常规制剂相当。