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依那普利治疗慢性心力衰竭患者:一项安慰剂对照、随机、双盲研究。

Enalapril in patients with chronic heart failure: a placebo-controlled, randomized, double-blind study.

作者信息

Sharpe D N, Murphy J, Coxon R, Hannan S F

出版信息

Circulation. 1984 Aug;70(2):271-8. doi: 10.1161/01.cir.70.2.271.

Abstract

A number of studies have shown short-term hemodynamic and symptomatic improvement in patients with congestive heart failure treated with angiotensin converting-enzyme inhibitors. The long-term efficacy of the oral long-acting converting-enzyme inhibitor enalapril remains to be established in controlled studies. We evaluated this drug in 36 patients with New York Heart Association functional class II to III heart failure who were clinically stable on digoxin and diuretic therapy. After baseline assessment of symptoms, exercise capacity, and results of echocardiographic examination and right heart catheterization, patients were randomly assigned to treatment with 5 mg enalapril twice daily (n = 18) or placebo (n = 18) in a double-blind fashion. The two groups had similar clinical, echocardiographic, and hemodynamic characteristics before treatment. After 3 months of treatment, the enalapril group showed a significant improvement as judged by subjective patient impression, functional class, and exercise duration (9.3 +/- 5.7 vs 17.6 +/- 5.6 min; p less than .001). Diuretic dosage was reduced in six patients and increased in one patient, one patient had died and another had been withdrawn from the study. In the placebo group there was no significant change with respect to patient impression, functional class, or exercise duration; diuretic dosage was increased in seven patients and four patients had died. Echocardiographic left ventricular dimensions were significantly reduced and left ventricular shortening fraction significantly increased in the enalapril group but were unchanged in the placebo group.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

多项研究表明,使用血管紧张素转换酶抑制剂治疗的充血性心力衰竭患者,其短期血液动力学及症状有所改善。口服长效血管紧张素转换酶抑制剂依那普利的长期疗效仍有待在对照研究中确定。我们对36例纽约心脏协会心功能II至III级的心力衰竭患者进行了评估,这些患者在接受地高辛和利尿剂治疗后病情临床稳定。在对症状、运动能力、超声心动图检查结果及右心导管检查结果进行基线评估后,患者被随机分为两组,一组每日两次服用5毫克依那普利(n = 18),另一组服用安慰剂(n = 18),采用双盲方式。治疗前,两组患者的临床、超声心动图及血液动力学特征相似。治疗3个月后,依那普利组在患者主观感受、心功能分级及运动持续时间方面均有显著改善(9.3±5.7对17.6±5.6分钟;p<0.001)。6例患者的利尿剂用量减少,1例患者用量增加,1例患者死亡,另1例退出研究。安慰剂组在患者主观感受、心功能分级或运动持续时间方面无显著变化;7例患者的利尿剂用量增加,4例患者死亡。依那普利组超声心动图显示左心室尺寸显著减小,左心室缩短分数显著增加,而安慰剂组则无变化。(摘要截选于250字)

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