老年冠心病无症状性心肌缺血患者长期应用复方丹参滴丸临床安全性研究

Evaluation on Safety of Long-term Administration with Compound Danshen Dripping Pill in the Old Patients with Coronary Heart Disease of Silent Myocardial Ischemia

目的:研究老年冠心病无症状性心肌缺血患者口服复方丹参滴丸6月的安全性。方法:选取100例老年冠心病患者,随机非盲分为对照组和治疗组各50例。对照组采用抗血小板、调血脂、抗缺血等冠心病常规治疗方法;治疗组采用常规治疗方法加复方丹参滴丸口服,每日3次、每次10丸,共6月。观察两组治疗前后血常规、肝功能、肾功能、血糖及血脂的变化和药物的不良反应。结果:治疗前后两组血糖、血脂无明显变化;无严重肝肾功能损害及其他严重不良反应发生;与复方丹参滴丸相关的不良反应共1例。结论:老年冠心病患者长期服用复方丹参滴丸的临床安全性良好。

Objective：To evaluate the safety of long-term（6 months） administration with Compound Danshen Dripping Pill（CDDP） in the old Patients with Coronary Heart Disease（CHD） of Silent Myocardial Ischemia.Methods：Adopting randomized non-blinded trial,100 patients with CHD were randomly and equally assigned to the CDDP group and the control group.Both received basic therapy for CHD,including anti-platelet,lipid regulating and anti-ischemia.The treatment group with additional CDDP 10 pills,taken orally three times per day in the CDDP group.They were followed up for 6 months.The adverse drug reactions occurred in the observation period were recored,and the laboratory indexes involving blood routine,liver function,renal function,blood glucose and blood lipids were detected before and after treatment.Results：The trial was completed in 96% of the pations,2 patients withdrew in the CDDP group and 2 patients in the control group;but none for the intolerable therapy.There were 1 case of adverse reation related to CDDP.No obvious change was found in blood glucose and blood lipids in the two groups before and after treatment.No serious adverse reaction and injury of liver and renal function or others happened.Conclution：Long-term admimistration of CDDP has favorable clinical safety for CHD pations.