中国冠心病二级预防研究

China coronary secondary prevention study (CCSPS)

目的判定在与西方人群相比血清胆固醇水平相对较低的中国冠心病患者中,通过血脂康调整血脂能否降低各种冠心病相关事件的危险性,并判定对各种原因死亡的影响.方法本研究为多中心、随机、双盲、安慰剂对照的长期随访临床试验,研究时间从1996年5月至2003年12月,在中国19个省市自治区的65家临床协作医疗中心,对4870例血清总胆固醇水平在4.40～6.47 mmol/L(170～250 mg/dl)之间、年龄在18～75岁,有明确心肌梗死史的中国冠心病患者进行了平均4年的随访观察,以比较血脂康胶囊0.6 g,2次/d与安慰剂的作用.主要终点为冠心病事件,包括非致死性心肌梗死及冠心病死亡,次要目标为能否减少非心血管病事件如肿瘤、脑卒中、自杀、经皮冠状动脉介入术(PCI)和(或)冠状动脉旁路移植术(CABG)需求以及总死亡.结果主要终点在血脂康治疗组的发生率为5.72%,安慰剂对照组为10.41%,治疗组相对危险降低45.1%(P=0.0000),其中冠心病死亡治疗组为3.79%,对照组为5.49%,治疗组相对危险降低31.0%(P=0.0048),非致死性心肌梗死治疗组为1.93%,对照组为4.92%,治疗组相对危险降低60.8%(P=0.0000).次要终点(脑卒中、肿瘤、PCI/CABG的需求)的发生率治疗组为69.2例次/1000人,对照组为100.4例次/1000人,治疗组相对危险降低31.1%(P=0.0004),其中PCI和(或)CABG的需求,治疗组为30.1例次/1000人,对照组为45.1例次/1000人,治疗组相对危险降低33.3%(P=0.0097).各种原因的死亡在治疗组为5.19%,对照组为7.74%,治疗组相对危险降低33.0%(P=0.0003),其中肿瘤死亡在治疗组降低54.7%(P=0.0138).在临床不良反应和实验室指标异常方面,治疗组和对照组之间差异无统计学意义.结论与安慰剂比较,血脂康胶囊治疗能显著降低冠心病患者非致死性心肌梗死及冠心病死亡的发生率.能显著减少对PCI和(或)CABG的需求,能显著减少肿瘤死亡和各种原因的总死亡.表明中国冠心病患者服用血脂康胶囊调整血脂可获得明显益处.

Objective The mean level of serum cholesterol in Chinese population with coronary heart disease (CHD) is relatively lower compared to that of western population Our study aimed to evaluate whether lipid lowering therapy with Xuezhikang can reduce the risk of cardiac events and total mortality in Chinese CHD patients Methods This study was designed as a random, double blinded, placebo controlled clinical trial in 66 centers in China and was conducted from may,1996 to December, 2003 4870 CHD patients (serum cholesterol level 4 40 6 47 mmol/L, age 18 75 years, with definite myocardial infarction history) were selected and treated with capsule Xuezhikang (0 6 g Bid) or placebo in addition to conventional therapy (control group) The mean follow up period was four years The primary end points were nonfatal myocardial infarction and deaths from CHD Results It has been shown at the end of the trial:(1) The incidence of the primary end points were 5 72% in Xuezhikang treatment group and 10 41% in control group, with a reduction of relative risk by 45 1% for treatment group( P =0 0000) Among the primary end points, the incidence of deaths from CHD was 3 79% in the treatment group and 5 49% in the control group, with a reduction of relative risk by 31 0% in treatment group( P <0 0048);(2) The incidence of nonfatal myocardial infarction reduced by 60 8% in treatment group compared to control group (1 93% vs 4 92%, P <0 0000);(3) The incidence of the secondary end points (stroke, tumor, PCI/CABG) also decreased by 31 1% in treatment group compared to control group (6 92% vs 10 04% P <0 0004) Among the secondary end points, the demand for PCI/CABG was 3 01% in the treatment group and 4 51% in the control group, with a reduction of relative risk by 33 3% in treatment group ( P =0 097); (4)The total mortality was lower in treatment group than control group, with a reduction of relative risk by 33 0% in treatment group (5 19% vs 7 74% P =0 0003) There were no significant differences in side effects and abnormal laboratory references between the two groups Conclusions Compared to placebo, Xuezhikang can significantly decrease the incidence of nonfatal myocardial infarction and deaths from CHD It can also reduce significantly the demand for PCI/CABG, the total mortality and the deaths from tumor.