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尼可地尔与美托洛尔治疗稳定型劳力性心绞痛的双盲对照研究。

A double-blind comparison of nicorandil and metoprolol in stable effort angina pectoris.

作者信息

Di Somma S, Liguori V, Petitto M, Carotenuto A, Bokor D, de Divitiis O, de Divitiis M

机构信息

Clinical Methodology and Cardioangiology Institute, University of Naples, Italy.

出版信息

Cardiovasc Drugs Ther. 1993 Feb;7(1):119-23. doi: 10.1007/BF00878320.

Abstract

The antianginal activities of nicorandil, 10 and 20 mg bid, and metoprolol, 100 mg bid, were compared in patients with stable effort angina pectoris in a randomized, double-blind parallel group study lasting 7 weeks. Twenty patients were enrolled into the trial and 16 patients completed the study. To evaluate the anti-ischemic effects of the two drugs, a treadmill exercise test was performed after a 1-week placebo run-in period and 6 weeks of treatment. On the same occasions, weekly sublingual nitroglycerin consumption and the number of anginal attacks were also recorded in the patient's diary. The total duration of exercise increased significantly with both nicorandil, 10 and 20 mg, and metoprolol (p < 0.01). Similar improvements were observed in the time to onset of ischemia with both treatments (p < 0.01). The double product at maximal comparable workload (MAX 1) was reduced with the two drugs (p < 0.05 for nicorandil and p < 0.01 for metoprolol), while at the maximal exercise time (MAX 2) it was reduced with metoprolol (p < 0.01) and slightly but not significantly increased with both doses of nicorandil. Weekly sublingual nitroglycerin consumption and anginal attacks were also significantly reduced a similar manner by both treatments (p < 0.01). In conclusion, nicorandil, 10 and 20 mg bid, exerted an anti-ischemic effect comparable with that of metoprolol in patients with stable effort angina pectoris.

摘要

在一项为期7周的随机、双盲平行组研究中,比较了尼可地尔(每日两次,每次10毫克和20毫克)和美托洛尔(每日两次,每次100毫克)对稳定型劳力性心绞痛患者的抗心绞痛作用。20名患者入组该试验,16名患者完成了研究。为评估两种药物的抗缺血作用,在为期1周的安慰剂导入期和6周的治疗期后进行了平板运动试验。在相同时间,还让患者在日记中记录每周舌下含服硝酸甘油的用量和心绞痛发作次数。尼可地尔10毫克和20毫克剂量组以及美托洛尔组的运动总时长均显著增加(p<0.01)。两种治疗方法在缺血发作时间方面均有类似改善(p<0.01)。两种药物均使最大可比工作量(MAX 1)时的双乘积降低(尼可地尔p<0.05,美托洛尔p<0.01),而在最大运动时间(MAX 2)时,美托洛尔使其降低(p<0.01),两种剂量的尼可地尔使其略有增加但无显著差异。两种治疗方法均以类似方式显著减少了每周舌下含服硝酸甘油的用量和心绞痛发作次数(p<0.01)。总之,对于稳定型劳力性心绞痛患者,每日两次服用10毫克和20毫克的尼可地尔产生的抗缺血作用与美托洛尔相当。

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