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长效与普通剂型莫西赛利对稳定型心绞痛患者运动能力和临床状况的短期及长期影响:一项多中心随机双盲交叉安慰剂对照试验

Short- and long-term effects of molsidomine retard and molsidomine nonretard on exercise capacity and clinical status in patients with stable angina: a multicenter randomized double-blind crossover placebo-controlled trial.

作者信息

Messin R, Karpov Y, Baikova N, Bruhwyler J, Monseu M J, Guns C, Géczy J

机构信息

Department of Cardiology, University Hospital Saint Pierre, Brussels, Belgium.

出版信息

J Cardiovasc Pharmacol. 1998 Feb;31(2):271-6. doi: 10.1097/00005344-199802000-00013.

DOI:10.1097/00005344-199802000-00013
PMID:9475269
Abstract

A multicenter, randomized, double-blind, crossover, placebo-controlled study was conducted in 90 isosorbide dinitrate responders showing stable angina to compare the efficacy of molsidomine retard, 8 mg b.i.d., with that of molsidomine, 4 mg t.i.d., for 6 weeks. Total work performance (workload x min) was significantly improved, compared with baseline and placebo until 8 and 12 h after molsidomine and molsidomine retard administration, respectively. ST-segment depression decreased significantly under the two treatments at 60 W as well as at maximal exercise. The rate-pressure product (heart rate x systolic blood pressure) decreased and increased significantly at submaximal and maximal exercise level, respectively. All these effects remained significant after 6-week treatment, with only the ST segment showing a nonsignificant tendency to improvement at maximal work. The frequency of anginal attacks and of sublingual nitroderivative-tablets consumption decreased significantly with molsidomine, 4 mg, and molsidomine retard, 8 mg. However, overall results showed that the latter form reduces myocardial ischemia more efficiently at submaximal exercise level, has a more prolonged effect on exercise tolerance, and maintains it at a somewhat higher level after 6-week treatment.

摘要

对90名服用硝酸异山梨酯后出现稳定型心绞痛的患者进行了一项多中心、随机、双盲、交叉、安慰剂对照研究,以比较每日两次服用8毫克缓释吗多明与每日三次服用4毫克吗多明的疗效,为期6周。与基线和安慰剂相比,分别在服用吗多明和缓释吗多明后8小时和12小时,总工作表现(工作量×分钟)显著改善。在60瓦以及最大运动量时,两种治疗下ST段压低均显著降低。在次最大运动量和最大运动量水平时,心率-血压乘积(心率×收缩压)分别显著降低和升高。经过6周治疗后,所有这些效应仍然显著,只有ST段在最大工作量时改善趋势不显著。服用4毫克吗多明和8毫克缓释吗多明后,心绞痛发作频率和舌下含服硝酸酯类药物的次数显著减少。然而,总体结果显示,后一种剂型在次最大运动量水平时能更有效地减轻心肌缺血,对运动耐量的影响持续时间更长,且在6周治疗后能将运动耐量维持在稍高的水平。

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引用本文的文献

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A pilot double-blind randomized placebo-controlled study of molsidomine 16 mg once-a-day in patients suffering from stable angina pectoris: correlation between efficacy and over time plasma concentrations.一项针对稳定型心绞痛患者每日一次服用16毫克莫西多明的双盲随机安慰剂对照试验研究:疗效与血浆浓度随时间的相关性。
Eur J Clin Pharmacol. 2003 Jul;59(3):227-32. doi: 10.1007/s00228-003-0597-z. Epub 2003 May 7.