中国冠心病二级预防研究:不同发病期患者的亚组分析

China coronary secondary prevention study: analysis of patients with different myocardial infarction history

目的探讨心肌梗死不同发病期患者服用血脂康胶囊的冠心病二级预防结果。方法对2135例心肌梗死发病期在28d至3个月和2735例发病期在3—60个月服用血脂康胶囊治疗的冠心病患者二级预防结果进行分析。结果血脂康治疗组与对照组比较，发病期在28d至3个月的患者中，冠心病事件减少56．7％（P〈0．0001）；总死亡事件减少48．6％（P=0．0002）；发病期在3—60个月之间的患者中，冠心病事件减少35．3％（P=0．0008），总死亡事件减少20．0％（P=0．1181）。结论血脂康在发病期28d至3个月的患者中的疗效好于在发病期3—60个月之间的患者。心肌梗死后患者尽早服用血脂康胶囊可获得更大的预防效果。

Objective To assess whether Xuezhikang was effective in the secondary prevention of coronary heart disease （CHD） for patients with different length of myocardial infarction （MI） history. Methods 2135 patients with MI history of 28 days to 3 months and 2735 patients with MI history of 3 months to 60 months were recruited separately to receive treatment with Xuezhikang capsule or placebo. The primary end-points were nonfatal myocardial infarction and death from CHD. Results The occurrence of coronary events were found to be not statistically significantly different for the two groups of patients. For patients with MI history of 28 days to 3 months, Xuezhikang significantly reduced the risk of CHD events by 56.7% （P〈0.000 1） and resulted in a 48.6 % （P=0.000 2） risk reduction in all-canse mortality as compared with placebo. For patients with MI history of 3 months to 60 months, Xuezhikang significantly decreased the risk of CHD events by 35.3% （P =0.000 8） and led to a 20.0 % （P =0. 118 1） risk reduction in the all-canse mortality as compared with placebo. Adverse effects and abnormal laboratory parameters did not differ significantly in the two groups of patients. Conclusions Xuezhikang is more effective for patients with MI history of 28 days to 3 months as compared with patients with MI history of 3 months to 60 months. Patients with MI history should be treated with Xuezhikang early in order to achieve better prevention of CHD.