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硝苯地平治疗先兆及急性心肌梗死患者:一项随机、双盲、安慰剂对照比较研究。

Nifedipine therapy for patients with threatened and acute myocardial infarction: a randomized, double-blind, placebo-controlled comparison.

作者信息

Muller J E, Morrison J, Stone P H, Rude R E, Rosner B, Roberts R, Pearle D L, Turi Z G, Schneider J F, Serfas D H

出版信息

Circulation. 1984 Apr;69(4):740-7. doi: 10.1161/01.cir.69.4.740.

Abstract

Preliminary clinical and laboratory observations suggest that nifedipine might prevent progression of threatened myocardial infarction by reversing coronary spasm or might limit necrosis during the course of acute myocardial infarction. We screened 3143 patients with ischemic pain of greater than 45 min duration and randomly assigned 105 eligible patients with threatened myocardial infarction and 66 with acute myocardial infarction to receive nifedipine (20 mg orally every 4 hr for 14 days) or placebo plus standard care. Treatment was started 4.6 +/- 0.1 hr after the onset of pain. Infarct size index was calculated by the MB-creatine kinase (CK) method and expressed as CK-geq/m2 +/- SE. The incidence of progression to infarction among patients with threatened myocardial infarction was not significantly altered by nifedipine (36 of 48 [75%] for placebo-treated and 43 of 57 [75%] for nifedipine-treated patients). Furthermore, infarct size index was similar among placebo- and nifedipine-treated patients (16.9 +/- 1.5 MB-CK-geq/m2, n = 65, and 17.0 +/- 1.5 MB-CK-geq/m2, n = 68, respectively) with threatened myocardial infarction who exhibited infarction and for those with acute myocardial infarction. Among the 171 eligible patients randomly assigned to drug or placebo, 6 month mortality did not differ significantly (8.5% for placebo vs 10.1% for nifedipine, NS), but mortality in the 2 weeks after randomization was significantly higher for nifedipine-treated patients (0% for placebo compared with 7.9% for nifedipine, p = .018).(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

初步的临床和实验室观察表明,硝苯地平可能通过逆转冠状动脉痉挛来预防有心肌梗死风险的患者病情进展,或者在急性心肌梗死过程中限制坏死范围。我们筛选了3143例缺血性疼痛持续时间超过45分钟的患者,随机分配105例有心肌梗死风险的合格患者和66例急性心肌梗死患者接受硝苯地平治疗(每4小时口服20毫克,共14天)或安慰剂加标准护理。疼痛发作后4.6±0.1小时开始治疗。梗死面积指数通过肌酸激酶(CK)法计算,以CK-geq/m2±标准误表示。硝苯地平并未显著改变有心肌梗死风险患者进展为梗死的发生率(安慰剂治疗组48例中有36例[75%],硝苯地平治疗组57例中有43例[75%])。此外,在发生梗死的有心肌梗死风险的患者以及急性心肌梗死患者中,安慰剂治疗组和硝苯地平治疗组的梗死面积指数相似(分别为16.9±1.5 MB-CK-geq/m2,n = 65,和17.0±1.5 MB-CK-geq/m2,n = 68)。在随机分配接受药物或安慰剂治疗的171例合格患者中,6个月死亡率无显著差异(安慰剂组为8.5%,硝苯地平组为10.1%,无统计学意义),但随机分组后2周内,硝苯地平治疗患者的死亡率显著更高(安慰剂组为0%,硝苯地平组为7.9%,p = 0.018)。(摘要截断于250字)

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