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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.

DOI:10.1007/BF00878320
PMID:8485067
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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本文引用的文献

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Effects of SG-75 (nicorandil) on electrical activity of canine cardiac Purkinje fibers: possible increase in potassium conductance.SG - 75(尼可地尔)对犬心脏浦肯野纤维电活动的影响:钾电导可能增加。
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Controlled comparison of the pharmacodynamic effects of nicorandil (SG-75) and isosorbide dinitrate in man.尼可地尔(SG - 75)与硝酸异山梨酯对人体药效学作用的对照比较。
Eur J Clin Pharmacol. 1984;26(6):681-5. doi: 10.1007/BF00541925.
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Effectiveness of nicorandil (SG-75), a new long-acting drug with nitroglycerin effects, in patients with coronary artery disease: improved left ventricular function and regional wall motion and abolition of pacing-induced angina.
尼可地尔对择期经皮冠状动脉介入治疗的冠心病患者的心脏保护作用。
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Vasodilator Therapy: Nitrates and Nicorandil.血管扩张剂治疗:硝酸盐类和尼可地尔。
Cardiovasc Drugs Ther. 2016 Aug;30(4):367-378. doi: 10.1007/s10557-016-6668-z.
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Use of nicorandil is Associated with Increased Risk for Gastrointestinal Ulceration and Perforation- A Nationally Representative Population-based study.尼可地尔的使用与胃肠道溃疡和穿孔风险增加相关——一项基于全国代表性人群的研究。
Sci Rep. 2015 Jun 29;5:11495. doi: 10.1038/srep11495.
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Pharmacological treatment of chronic stable angina pectoris.慢性稳定性心绞痛的药物治疗。
Clin Med (Lond). 2013 Feb;13(1):63-70. doi: 10.7861/clinmedicine.13-1-63.
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Use of nicorandil in cardiovascular disease and its optimization.尼可地尔在心血管疾病中的应用及其优化。
Drugs. 2011 Jun 18;71(9):1105-19. doi: 10.2165/11592300-000000000-00000.
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K(ATP) channel therapeutics at the bedside.床边的钾离子通道开放剂治疗学
J Mol Cell Cardiol. 2005 Jul;39(1):99-112. doi: 10.1016/j.yjmcc.2005.04.006.
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Impact of nicorandil in angina: subgroup analyses.尼可地尔对心绞痛的影响:亚组分析。
Heart. 2004 Dec;90(12):1427-30. doi: 10.1136/hrt.2003.026310.
新型长效具有硝酸甘油作用的药物尼可地尔(SG - 75)对冠心病患者的疗效:改善左心室功能和局部室壁运动,消除起搏诱发的心绞痛。
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Am J Cardiol. 1989 Jun 20;63(21):71J-74J. doi: 10.1016/0002-9149(89)90209-9.
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Exercise capacity after single and twice-daily doses of nicorandil in chronic stable angina pectoris.慢性稳定型心绞痛患者每日单次及两次服用尼可地尔后的运动能力
Am J Cardiol. 1989 Jun 20;63(21):66J-70J. doi: 10.1016/0002-9149(89)90208-7.