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硝苯地平治疗不稳定型心绞痛:一项双盲随机试验

Nifedipine in unstable angina: a double-blind, randomized trial.

作者信息

Gerstenblith G, Ouyang P, Achuff S C, Bulkley B H, Becker L C, Mellits E D, Baughman K L, Weiss J L, Flaherty J T, Kallman C H, Llewellyn M, Weisfeldt M L

出版信息

N Engl J Med. 1982 Apr 15;306(15):885-9. doi: 10.1056/NEJM198204153061501.

Abstract

We assessed the efficacy of adding nifedipine to the conventional treatment of unstable angina in 138 patients in a prospective, double-blind, randomized, placebo-controlled trial. There was no difference between the two groups in the dose of conventional antianginal medication or in age, prior myocardial infarction, ejection fraction, or other risk factors. Failure of medical treatment (defined as sudden death, myocardial infarction, or bypass surgery within four months) occurred in 43 of 70 patients given placebo and in 30 of 68 given nifedipine. Kaplan-Meier survival-curve analysis of the number and time dependence of treatment failures demonstrated a benefit of nifedipine over placebo (P = 0.03). The benefit was particularly marked in patients with ST-segment elevation during angina (P = 0.02). Side effects (transient hypotension or diarrhea) required withdrawal of the drug from four patients given nifedipine and from one given placebo. We conclude that the addition of nifedipine to conventional therapy is safe and effective in unstable angina.

摘要

在一项前瞻性、双盲、随机、安慰剂对照试验中,我们评估了在138例不稳定型心绞痛患者中,硝苯地平联合常规治疗的疗效。两组在常规抗心绞痛药物剂量、年龄、既往心肌梗死、射血分数或其他危险因素方面无差异。接受安慰剂治疗的70例患者中有43例出现药物治疗失败(定义为4个月内猝死、心肌梗死或搭桥手术),接受硝苯地平治疗的68例患者中有30例出现药物治疗失败。对治疗失败的数量和时间依赖性进行的Kaplan-Meier生存曲线分析表明,硝苯地平优于安慰剂(P = 0.03)。这种益处在心绞痛发作时伴有ST段抬高的患者中尤为明显(P = 0.02)。副作用(短暂性低血压或腹泻)导致4例接受硝苯地平治疗的患者和1例接受安慰剂治疗的患者停药。我们得出结论,在不稳定型心绞痛的常规治疗中添加硝苯地平是安全有效的。

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