冠心病稳定性心绞痛患者长期应用曲美他嗪的临床耐受性与安全性评价

Evaluation on Tolerability and Safety of Long-term Administration with Trimetazidine Dihydrochloride Tablets in Patients with Coronary Heart Disease of Stable Angina Pectoris

目的评价冠心病稳定性心绞痛患者口服曲美他嗪6个月的耐受性与安全性。方法采用随机非盲两组平行对照研究方法。将120例冠心病患者随机分为两组，各60例。对照组采用冠心病基础用药包括抗血小板、调脂、抗缺血等常规治疗：治疗组采用冠心痛基础用药加口服曲美他嗪每日3次，每次20mg，共6个月。随访6个月，观察两组用药的耐受性、药物不良反应，治疗前后血常规、肝肾功能、血糖及血脂的变化。结果试验总完成率95％，其中治疗组2例、对照组4例脱落，无患者因不耐受药物而脱落。与曲美他嗪相关的不良反应共1例；两组治疗前后血糖、血脂亦无明显变化，无严重肝肾功能损害及其他严重不良反应发生。结论冠心病患者长期服用曲美他嗪的临床耐受性和安全性良好。

Objective To evaluate the safety and tolerability of long term （6 months） administration with Trimetazidine Dihydrochloride Tablets （VASOREL） in patients with coronary heart disease （CHD） of stable angina pecetoris. Methods Adopting randomized non-blinded and parallel controlled trial, 120 patients with CHD were randomly and equally assigned to the VASOREL group and the control group. Both received basic therapy for CHD, including anti-platelet, lipid regulating and anti-ischemia with additional VASOREL 2 pills, taken orally 20mg tid in the VASOREL group. They were followed up for 6 months. The drug tolerability and adverse drug reactions occurred in the observation period were recorded, and the laboratory indexes involving blood routine, liver function, renal function, blood glucose and blood lipids were detected hefor and after treatment. Results The trial was completed in 95% of the patients, 2 patients withdrew in the VASOREL group and 4 patients in the control group; but none for the intolerable therapy. There were 1 case of adverse reaction related to VASOREL. No obvious change was found in blood glucose and blood lipids in the two groups before and after teatment. No serious adverse reaction and injury of liver and renal function or others happened. Conclusion Long-term administration of VASOREL has favorable clinical tolerabilitv and safety for CHD natients.