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目的曲美他嗪是一种新型的抗心肌缺血药物,能够改善患者的运动耐量并有心肌的直接保护作用,同时并没有明显血流动力学效应。本研究评价冠心病合并左心功能不全的患者在常规治疗情况下加用曲美他嗪6个月后对左心室射血分数(LVEF)、心绞痛的影响,并评价其临床疗效及耐受性。方法60例平均(63±10)岁冠心病合并左心功能不全(LVEF<40%)的患者进入本项开放性多中心临床试验。所有患者在常规治疗的基础上加用每日60mg曲美他嗪治疗6个月,随诊观察患者临床情况以及超声心动图指标的变化。结果60例患者均可耐受在常规治疗基础上加用每日60mg曲美他嗪的治疗,无药物相关不良事件发生。LVEF由(32.4±6.3)%上升至(41.8±10.8)%(P<0.001);运动耐量(NYHA分级)明显改善(P<0.001);随诊期间患者每周心绞痛发作次数与硝酸甘油的用量分别减少2.29次和1.20片(P<0.001)。结论冠心病合并左心功能不全的患者在常规治疗基础上加用曲美他嗪是安全的,同时能明显提高左心室射血分数,减少心绞痛的发作频率。
Purpose Trimetazidine is a novel anti-ischemic drug that improves patient movement tolerance and has direct myocardial protection with no significant hemodynamic effects. This study was designed to evaluate the effect of trimetazidine on left ventricular ejection fraction (LVEF) and angina pectoris after 6 months of conventional treatment in patients with coronary heart disease complicated with left ventricular dysfunction. The clinical efficacy and tolerability . Methods Sixty patients (63 ± 10 years) with coronary heart disease with left ventricular dysfunction (LVEF <40%) entered this open, multicenter clinical trial. All patients were treated with trimetazidine 60 mg daily for 6 months on the basis of routine treatment. The clinical and echocardiographic parameters were observed and followed up. Results All the 60 patients were able to tolerate the daily treatment with trimetazidine 60 mg on the basis of routine treatment without any drug-related adverse events. LVEF increased from (32.4 ± 6.3)% to (41.8 ± 10.8)% (P <0.001), and exercise tolerance (NYHA classification) improved significantly (P <0.001). The number of patients with angina pectoris and the amount of nitroglycerin Decreased 2.29 times and 1.20 pieces respectively (P <0.001). Conclusions Patients with coronary heart disease complicated with left ventricular dysfunction are safe on the basis of conventional treatment with trimetazidine, and at the same time can significantly improve left ventricular ejection fraction and reduce the frequency of angina pectoris.