血脂康调整血脂对冠心病的二级预防研究

Secondary Prevention Effect of Xuezhikang on Coronary Heart Disease

目的:研究血脂康调整血脂对冠心病的二级预防作用。方法:采用双盲、随机、安慰剂对照长期随访临床试验,研究时间从1997年至2003年,对97例血清总胆固醇(TC)水平在4．40～6．47 mmoL／L(170～250 mg/dl)之间、年龄18～75岁,有明确心肌梗死的冠心病患者分为血脂康组(49例),安慰剂组(48例),主要终点为冠心病事件(包括非致死性心肌梗死和冠心病死亡)。次要终点为总死亡。同时观察血脂变化。结果:冠心病事件和总死亡在血脂康组发生率分别为4．25％和6．12％,在安慰剂组发生率分别为18．75％与20．83％。两组冠心病事件和总死亡率分别比较,差异均有统计学意义,P<0．05。调脂治疗后,血脂康组TC、甘油三酯(TG)、低密度脂蛋白胆固醇分别降低19．04％、13．76％、25．52％;对照组TC、TG、低密度脂蛋白胆固醇分别降低3．21％、4．57％、1．21％;血脂康组高密度脂蛋白胆固醇升高4．35％,安慰剂组升高1．77％,两组间各指标比较均有统计学差异。在临床不良反应和实验室指标异常方面,血脂康组和安慰剂组间差异无统计学意义。结论:与安慰剂组比较,血脂康能显著降低冠心病心肌梗死患者的冠心病事件与总死亡的发生率。

Objective ：To study the secondary prevention effect of Xuezhikang on coronary heart disease （CHD）. Methods：This study was designed as a double-blinded, random, placebo controlled clinical trial conducted from 1997 to 2003. Ninety-seven CHD patients with total cholesterol （TC） 4. 40-6.47 mmol/L and definite myocardial infarction history（ age 18-75 years）were selected and treated with either capsule Xuezhikang（ n = 49 ）or placebo（ n = 48 ） in addition to conventional therapy. The primary end-points were nonfatal myocardial infarction and deaths from CHD. Total death rate and the parameter of blood lipid levels were monitored. Results ： （ 1 ） The incidence of the primary end-points and the total mortality in Xuezhikang group were 4. 25 % and 6. 12%, compared with 18.75% and 20.83% in the control group. There were significant differences between groups （P 〈0.05 ）. After Xuezhikang treatment TC decreased by 19.04% ,low density lipoprotein cholesterol （LDL-C） by 25.52% and triglyceride TG by 13.76% ,whereas high density lipoprotein cholesterol （HDL-C） incresed by 4. 35%. In the control group TC decreased by 3.21% ,LDL-C by 1.21% and TG by 4. 57%, whereas HDL-C increased by 1.77%. The difference between groups was significant. There were no siginificant differences in side effects and abnormal laboratory references between groups. Conclusion： Compares to placebo, Xuezhikang can significantly decrease the incidence of nonfatal myocardial infarction or deaths from CHD. It can also reduce the total mortality.