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伊拉地平对冠心病合并慢性心力衰竭患者的急性血流动力学及长期临床疗效:一项双盲、安慰剂对照研究。

Acute hemodynamic and long-term clinical effects of isradipine in patients with coronary artery disease and chronic heart failure. A double-blind, placebo-controlled study.

作者信息

van den Toren E W, van Veldhuisen D J, van Bruggen A, van den Broek S A, van Gilst W H, Lie K I

机构信息

Department of Cardiology/Thoraxcenter, University Hospital Groningen, Netherlands.

出版信息

Int J Cardiol. 1996 Jan;53(1):37-43. doi: 10.1016/0167-5273(95)02506-5.

Abstract

To assess the acute hemodynamic and long-term clinical effects of isradipine, a calcium antagonist of the dihydropyridine class, we performed a double-blind, placebo-controlled parallel study in 19 patients with coronary artery disease (CAD) and stable chronic heart failure (CHF). Their mean age was 56 +/- 5 years, and left ventricular ejection fraction (LVEF) was 0.18 +/- 0.05. Patients were treated with diuretics and digoxin only. All were clinically stable and in sinus rhythm. The acute hemodynamic study showed that (intravenous) isradipine increased cardiac index (+36%) and stroke volume index (+30%) (both P < 0.001), while systemic vascular resistance (-33%) and mean arterial pressure (-10%) decreased (both P < 0.005). Filling pressures and heart rate were not affected. Of the 19 patients, 17 completed the 12 week study; 2 patients on placebo (1 death, 1 side-effects) but no patient on isradipine (5 mg 3 times daily) dropped out. After 12 weeks, peak oxygen consumption (VO2), LVEF, echocardiographic indices, and other clinical parameters were unaffected by treatment. Repeat invasive hemodynamic measurements showed that the initial improvement by isradipine was not present anymore. In conclusion, despite a beneficial acute hemodynamic effect, isradipine has no favorable clinical influence during prolonged treatment in patients with mild to moderate CHF.

摘要

为评估二氢吡啶类钙拮抗剂伊拉地平的急性血流动力学效应和长期临床效果,我们对19例冠心病(CAD)合并稳定型慢性心力衰竭(CHF)患者进行了一项双盲、安慰剂对照的平行研究。他们的平均年龄为56±5岁,左心室射血分数(LVEF)为0.18±0.05。患者仅接受利尿剂和地高辛治疗。所有患者临床病情稳定,均为窦性心律。急性血流动力学研究表明,(静脉注射)伊拉地平可使心脏指数增加36%,每搏量指数增加30%(均P<0.001),而全身血管阻力降低33%,平均动脉压降低10%(均P<0.005)。充盈压和心率未受影响。19例患者中,17例完成了为期12周的研究;2例服用安慰剂的患者(1例死亡,1例出现副作用)退出,但服用伊拉地平(每日3次,每次5mg)的患者无一人退出。12周后,峰值耗氧量(VO2)、LVEF、超声心动图指标及其他临床参数均未受治疗影响。重复进行的有创血流动力学测量显示,伊拉地平最初产生的改善已不复存在。总之,尽管伊拉地平具有有益的急性血流动力学效应,但在轻度至中度CHF患者的长期治疗中,它并无有利的临床影响。

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