小剂量阿司匹林在2180例高血压病患者心脑血管事件一级预防中的作用

Low-Dose Aspirin Time-Release for the Primary Prevention of Cerebro-Cardiovascular Accidents in Hypertensive Patients——A Multicenter Randomized Controlled Clinical Study among 2 180 Individuals with Hypertention

目的 探讨小剂量阿司匹林缓释片对高血压患者心脑血管事件一级预防的作用。方法 由湖南省心脑血管痛防治网络协作组组织其网络内的13家三甲和二甲医院参与完成前瞻性随机对照研究。2274例高血压患者被随机分为试验组和对照组，其中试验组1186例，在血压控制正常后给予肠溶阿司匹林缓释片50～100mg/d及常规降压治疗；对照组1088例，只给予常规降压治疗，观察两组患者心脑血管事件的发生情况。平均随访3．2年，最后2180例完成试验，其中试验组1151例，对照组1029例。结果试验组各事件的累积发病率为总事件3．6％、脑梗死2．1％、脑出血0．7％、心肌梗死0．2％、总死亡0．4％、因事件死亡0．2％，对照组分别为总事件5．2％、脑梗死3．6％、脑出血1．3％、心肌梗死0．9％、总死亡0．4％、因事件死亡0．3％。试验组和对照组相比，心肌梗死发病率降低，其相对危险度为0．204（95％可信区间为0．044～0．943），具有统计学差异（P〈0．05）。而两组的心脑血管事件总发生率及脑梗死、脑出血、因事件死亡等终点事件比较没有统计学差异（P〉0．05）。与对照组比，试验组发生心脑血管事件的相对危险度为0．701（95％可信区间为0．469～1．048），发生脑梗死的相对危险度为0．815（95％可信区间为0．470～1．412），发生脑出血的相对危险度为0．567（95％可信区间为0．235～1．368），因心脑血管事件死亡的相对危险度为3．645（95％可信区间为0．407～32．614），差异无统计学意义（P〉0．05）。结论 高血压患者常规降压治疗的同时加用小剂量阿司匹林缓释片可以显著降低心肌梗死的发生率，且未见增加脑出血的风险，可以起到一级预防的作用。

Aim To evaluate the effect of aspirin time-release on the incidence of cerebro-cardiovascular accidents in hypertensive patients.Methods This study was an opening, randomized, and controlled clinical prospective research, participated by 13 ＂the 3rd degree and grade A＂hospitals and ＂the 2rid degree and grade A＂ hospitals which were organized by the eerebro-cardiovaseular disease interventional net of hunan province coordinating center.2 274 patients were randomly assigned to treatment group and control group,There are 1 286 patients in treated group assigned to aspirin 50 - 100 mg/d besides anfi-hy pertensive treatment,while 1 088 patients in control group received only routine anfi-hypertens＇ive therapy.The average follow-up time was 3.2 years （range 1 -4 years）. Finally 2 180 patients had completed the study which included 1 151 treated group patients and 1 029 control group patients.Results In treated group,the cumulative incidence risk of total eerebro-eardiovaseular accidents, cerebral infarction,cerebral hemorrhage, myocardial infarction, total death, death caused by cerebro-cardiovascular accidents was 3.6%, 2.1%, 0.7%, 0.2%, 0.4%, 0.2%,but in control group the cumulative incidence risk of each event was 5.2%, 3.6%, 1.3%, 0.9%, 0.4%, 0.3%.The study observed that active treatment obviously reduced the incidence of fatal and non-fatal acute myocardial infarctions （ P〈0.05）, compared ＂with the controll group, the relative risk （95% confidence interval,95% CI） was 0.204 （0.044 - 0.943）. But the relative risk of accidents, cerebra/infarction, cerebral hemorrhage was 0.701 （0.469 - 1.048）, 0.815 （0.470- 1.412）, 0.567 （0.235 - 1.368）, respectively, Conclusions are nonsignificant. Furthermore, the relative risk of death caused by cerebro-cardiovascular accidents ,was 3.645 （0.407 - 32.614）. Conclusions The active therapy with low-dose aspirin could significantly reduce the incidence of fatal and non-fatal acute myocardial infarctions in hypertensive patients. And there was no increased risk of stroke or bleeding. So it has effect on the primary prevention.