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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病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。
Objective To investigate the effect of low dose aspirin sustained release tablets on primary prevention of cardiovascular and cerebrovascular events in patients with essential hypertension. METHODS: Thirteen top-three and two-year-old Hospitals within their network were included in the collaborative effort of the Cardiovascular and Cerebrovascular Disease Prevention Network in Hunan Province to complete a prospective randomized controlled trial. 2274 cases of hypertension were randomly divided into experimental group and control group, of which 1186 cases in the experimental group, given normal blood pressure control enteric-coated aspirin sustained release tablets 50 ~ 100mg / d and conventional antihypertensive treatment; control group of 1088 cases, only Give routine antihypertensive treatment, observe the occurrence of cardiovascular and cerebrovascular events in both groups. The average follow-up of 3.2 years, the last 2180 cases completed the trial, of which 1151 cases of experimental group, control group 1029 cases. Results The cumulative incidence of each event in the experimental group was 3.6% for the total event, 2.1% for the cerebral infarction, 0.7% for the cerebral hemorrhage, 0.2% for the myocardial infarction, 0.4% for the total death and 0.2% for the event. The control group was 5.2% 3.6% of cerebral infarction, 1.3% of cerebral hemorrhage, 0.9% of myocardial infarction, 0.4% of total death and 0.3% of death due to an event. Compared with the control group, the incidence of myocardial infarction was lower in the experimental group than in the control group, with a relative risk of 0.204 (95% confidence interval 0.044 to 0.943) with statistical significance (P <0.05). The total incidence of cardiovascular and cerebrovascular events and cerebral infarction, cerebral hemorrhage, death due to events such as end points were not statistically different (P> 0.05). Compared with the control group, the relative risk of cardiovascular and cerebrovascular events in the test group was 0.701 (95% confidence interval 0.469-1.048), and the relative risk of developing cerebral infarction was 0.815 (95% confidence interval 0.470-1.412) , The relative risk of developing cerebral hemorrhage was 0.567 (95% confidence interval 0.235 to 1.368). The relative risk of death from cardiovascular and cerebrovascular events was 3.645 (95% confidence interval 0.407 to 32.614), with no significant difference Significance (P> 0.05). Conclusions Conventional antihypertensive treatment combined with low-dose aspirin sustained-release tablets can significantly reduce the incidence of myocardial infarction, and no increase in the risk of cerebral hemorrhage can play a role in prevention.