阿司匹林缓释片对2430例高危人群心脑血管事件发生率的影响
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A Multicenter Clinical Study of the Effect of Aspirin Time-Release on the Incidence of Cerebro-Cardiovascular Accidents in the High Risk Groups
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    为评价阿司匹林缓释片对高血压病或冠心病患者的心脑血管事件发生率的影响以及年龄、血压、性别、吸烟等高危因素的影响。由湖南省医院管理协会牵头,联合省心脑血管病防治网络内的娄底市中心医院、衡阳市中心医院和长沙市第一人民医院等13家二甲和三甲医院进行了开放式多中心随机对照研究,完成临床研究病例2430例,其中治疗组12 6 4例,在给予降压或冠心病常规治疗的基础上,加用塞宁(肠溶阿司匹林缓释片) 5 0mg/d~10 0mg/d ;对照组116 6例,只给予常规治疗。结果发现,治疗组和对照组相比,事件总发生率及脑梗死、脑出血、心肌梗死等终点事件的发生率均具有明显的统计学差异(P<0 .0 5或者P<0 .0 0 1)。治疗组发生心脑血管事件较对照组的相对危险度为0 .34 1(0 .2 5 4~0 .46 0 ) ,其中发生脑梗死的相对危险度为0 .379(0 .2 5 8~0 .5 5 9) ,发生脑出血的相对危险度为0 .2 0 3(0 .10 6~0 .388) ,发生心肌梗死的相对危险度为0 .335 (0 .10 7~1.0 5 1) ,而因心脑血管事件死亡的相对危险度为0 .148(0 .0 5 2~0 .42 3)。此研究结果证实,给高危人群常规治疗的同时加用小剂量的阿司匹林缓释片可以显著降低脑卒中等心脑血管事件的发生率。研究结果还发现,年龄、血压、性别、吸烟及饮酒是影响高危人群心脑血管事件发生率的主要危险因素。

    Abstract:

    Aim To evaluate the effect of aspirin time-release on the incidence of cerebro-cardiovascular accidents in hypertensive or coronary patients, and to access the influence of age, blood pressure, sex, smoking, et al. Methods This study was an opening, multicenter, randomized, and controlled clinical research. 2 551 patients were enrolled and 2 430 patients had completed the study finally. 1 264 patients were assigned to aspirin time-release 50 mg/d~100 mg/d besides antihypertensive treatment or the routine therapy on coronary heart disease except anticoagulant. The other 1 166 control patients received only routine therapy. Results The study observed that active treatment obviously reduced the incidence of cerebro-cardiovascular accidents (p<0.05 or p<0.001). To compare with the controlled group, the RR (95%) of cerebro-cardiovascular accidents in treated group was 0.341 (0.254~0.460), and the RR of cerebral infarction, cerebral hemorrhage, myocardial infarction was 0.379 (0.258~0.559), 0.203 (0.106~0.388), 0.335 (0.107~1.051) respectively. Furthermore, the RR of death caused by cerebro-cardiovascular accidents was 0.148 (0.052~0.423). After stratifying of blood pressure, the RR of cerebro-cardiovascular accidents was higher in the people with high blood pressure. Conclusions The active therapy with low-dose aspirin could significantly reduce the incidence of cerebro-cardiovascular accidents in high risk group. It is beneficial to control the high risk factors such as blood pressure, smoking, drinking for hypertensive or coronary patients.

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湖南省心脑血管病防治网络协作组执笔人:袁洪,黄志军.阿司匹林缓释片对2430例高危人群心脑血管事件发生率的影响[J].中国动脉硬化杂志,2003,11(5):446~450.

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  • 收稿日期:2003-03-20
  • 最后修改日期:2003-08-26
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