三种5单硝酸异山梨酯缓释制剂对冠心病患者抗心肌缺血的作用及安全性评价

Anti-Ischemic Effect and Safety Evaluation of Three Isosorbide-5-Mononitrate Sustained Release Agents for Coronary Heart Disease With Myocardial Ischemia

目的评价3种5单硝酸异山梨酯缓释制剂对冠心病患者抗心肌缺血的作用和安全性。方法随机开放、三因素交叉、自身对照临床试验,受试者服用安慰剂1周后,随机交叉服用3种研究药物各1周,每周间各有1天洗脱期。在服用最后一次药物15分钟后患者进行运动平板试验,纪录运动心电图及1周内心绞痛发生情况和不良反应。结果异乐定长效缓释胶囊与依姆多缓释片、欣康缓释片相比,出现ST段压低1倍及以上所需时间明显延长,因发生心绞痛而中止运动试验的病例数明显减少。结论长效异乐定能较快速地产生对心肌缺血的保护作用,有效预防心绞痛的发生。

Objective ： To evaluate the anti-isehemic effect and safety of three isosorbide-5-mononitrate sustained release agents for coronary heart disease patients with myocardial ischemia. Methods： This was a randomized, open, three cross-over and self controlled study. The patients were randomized to receive placebo or three isosorbide-5-mononitrate sustained release drugs for one week each. There was one day for washout between two drugs. Fifteen minutes after the last dose, the patients underwent treadmill exercise. The electrocardiogram, occurrence of cardiac ischemic events and adverse events were recorded respectively. Results ： Compared with other two isosorbide-5-mononitrate sustained release agents, the time of doubled ST depression with elantan long was delayed and the case number, which needed to discontinue treadmill exercise became obviously less. Conclusion： Elantan long can rapidly provide cardioprotective effect and prevent occurrence of angina pectoris.