Whitworth H B, Roubin G S, Hollman J, Meier B, Leimgruber P P, Douglas J S, King S B, Gruentzig A R
J Am Coll Cardiol. 1986 Dec;8(6):1271-6. doi: 10.1016/s0735-1097(86)80296-0.
This double-blind, randomized study evaluated the effect of nifedipine on restenosis after coronary angioplasty. Two hundred forty-one patients with dilation of 271 coronary sites were randomized at the time of hospital discharge to receive nifedipine, 10 mg (123 patients), or placebo (118 patients) four times daily for 6 months. No patient was known to have coronary artery spasm. The mean duration of therapy was 4.4 +/- 2 (mean +/- SD) months for nifedipine and 4.3 +/- 2 months for placebo. A restudy angiogram was available in 100 patients (81%) in the nifedipine group and 98 patients (83%) in the placebo group. A recurrent coronary stenosis was noted in 28% of patients in the nifedipine group and in 29.5% of those in the placebo group (p = NS). The mean diameter stenosis was 36.4 +/- 23% for the nifedipine group and 36.7 +/- 23% for the placebo group (p = NS). By pill count, 78% of patients receiving nifedipine and 82% of those receiving placebo complied with the study drug regimen. Coronary stenosis recurred in 33% of patients in the placebo group and in 29% of patients in the nifedipine group who complied with the regimen and had angiograms (p = NS). In conclusion, the study did not demonstrate a significant beneficial effect of nifedipine on the incidence of recurrent stenosis after successful percutaneous transluminal coronary angioplasty.
这项双盲随机研究评估了硝苯地平对冠状动脉血管成形术后再狭窄的影响。241例271个冠状动脉部位扩张的患者在出院时被随机分组,分别接受硝苯地平(10毫克,123例患者)或安慰剂(118例患者),每日4次,共6个月。已知所有患者均无冠状动脉痉挛。硝苯地平组的平均治疗时长为4.4±2(均值±标准差)个月,安慰剂组为4.3±2个月。硝苯地平组100例患者(81%)和安慰剂组98例患者(83%)进行了复查血管造影。硝苯地平组28%的患者出现冠状动脉再狭窄,安慰剂组为29.5%(p值无统计学意义)。硝苯地平组的平均直径狭窄率为36.4±23%,安慰剂组为36.7±23%(p值无统计学意义)。通过药丸计数,接受硝苯地平治疗的患者中有78%、接受安慰剂治疗的患者中有82%遵守了研究药物治疗方案。在遵守治疗方案并进行血管造影的患者中,安慰剂组33%出现冠状动脉再狭窄,硝苯地平组为29%(p值无统计学意义)。总之,该研究未证明硝苯地平对成功的经皮腔内冠状动脉血管成形术后再狭窄发生率有显著有益作用。