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尼可地尔与普萘洛尔治疗轻度劳力性稳定型心绞痛的疗效:一项长期、双盲、随机研究。

Efficacy of nicorandil versus propranolol in mild stable angina pectoris of effort: a long-term, double-blind, randomized study.

作者信息

Meeter K, Kelder J C, Tijssen J G, Bucx J J, Henneman J A, Kerker J P, Hugenholtz P G

机构信息

Academic Hospital Rotterdam Dijkzigt, Erasmus University Rotterdam, The Netherlands.

出版信息

J Cardiovasc Pharmacol. 1992;20 Suppl 3:S59-66.

PMID:1282178
Abstract

Nicorandil is a potent coronary vasodilator. To assess its long-term antianginal effect, we designed a randomized, parallel double-blind trial of 6 weeks' duration comparing nicorandil (10 or 20 mg b.i.d.) with propranolol (40 or 80 mg t.i.d.). The study comprised 77 men with stable angina, no maintenance medication at entry, and an exercise test positive for angina and ST-segment depression. The therapy was started with 10 mg nicorandil b.i.d. or 40 mg propranolol t.i.d. After 3 weeks, the dosage could be doubled according to clinical criteria. Four men receiving nicorandil and one receiving propranolol were withdrawn with side effects; in three cases, the data were not complete. Thus, comparative data were obtained in 69 patients; in 51 of these (26 receiving nicorandil and 25 receiving propranolol), the dosage was increased to the higher level. Blood pressure and heart rate were unaltered by nicorandil and lowered by propranolol. The number of anginal attacks decreased relative to baseline on nicorandil and propranolol (p < 0.002), but total exercise duration was not influenced by either drug. The exercise test performed 2 h after either pill ingestion showed a decrease and a delay in occurrence of myocardial ischemia. The test performed 12 h after medication exhibited reduced ischemia, whereas only propranolol resulted in delayed ST-segment depression. The double product of heart rate and systolic blood pressure was affected only slightly by nicorandil and reduced significantly by propranolol (p < 0.001). Thus, nicorandil medication affords similar improvement as propranolol in patients with angina pectoris, but the mode of action appears to be different.

摘要

尼可地尔是一种强效冠状动脉扩张剂。为评估其长期抗心绞痛作用,我们设计了一项为期6周的随机、平行双盲试验,比较尼可地尔(10或20毫克,每日两次)与普萘洛尔(40或80毫克,每日三次)。该研究纳入了77名稳定型心绞痛男性患者,入组时未服用维持药物,运动试验显示心绞痛和ST段压低呈阳性。治疗起始剂量为尼可地尔每日两次,每次10毫克或普萘洛尔每日三次,每次40毫克。3周后,可根据临床标准将剂量加倍。4名服用尼可地尔和1名服用普萘洛尔的患者因副作用退出;3例数据不完整。因此,获得了69例患者的比较数据;其中51例(26例服用尼可地尔,25例服用普萘洛尔)剂量增加至更高水平。尼可地尔对血压和心率无影响,普萘洛尔则使其降低。与基线相比,尼可地尔和普萘洛尔治疗后心绞痛发作次数均减少(p<0.002),但两种药物均未影响总运动持续时间。服药后2小时进行的运动试验显示心肌缺血的发生减少且延迟。服药后12小时进行的试验显示缺血减轻,而只有普萘洛尔导致ST段压低延迟。心率与收缩压的乘积仅受尼可地尔轻微影响,而普萘洛尔使其显著降低(p<0.001)。因此,尼可地尔治疗对心绞痛患者的改善作用与普萘洛尔相似,但作用方式似乎不同。

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