脑安胶囊对320例卒中高危患者的干预效果

Evaluation of intervenient effects of Naoan capsule on patients with high-risk of stroke

目的评价脑安胶囊对卒中高危患者的中长期干预效果。方法在门诊与住院患者中,筛选出有高血压、心脏病、糖尿病、血脂异常、卒中家族史等危险因素,同时年龄≥40岁、脑血管血流动力学参数（CVHP）积分〈75分者320例,按随机数字法分为脑安胶囊组162例及阿司匹林组158例。脑安胶囊组口服脑安胶囊,2次/d,2粒/次;阿司匹林组口服拜阿司匹林,100mg/次,1次/d。干预时间均为24～36个月。每年随访1次,随访内容为血压、血脂、CVHP积分的水平以及卒中的发病率及病死率。结果①脑安胶囊组累积随访470人年,卒中发生率和病死率分别为1.915%和0.851%;阿司匹林组累积随访460人年,卒中发生率和病死率分别为4.130%和2.391%。脑安胶囊组卒中综合发生率及病死率均低于阿司匹林组（P〈0.05）。②脑安胶囊组干预前、后,收缩压为（162±11）、（130±7）mmHg,舒张压为（101±9）、（83±6）mmHg,CVHP积分值为（49±13）、（82±9）;阿司匹林组干预前、后,收缩压为（161±10）、（137±5）mmHg,舒张压为（99±7）、（90±4）mmHg,CVHP积分值为（49±12）、（70±11）。两组干预后收缩压、舒张压及CVHP积分值差异均有统计学意义（P〈0.01）。结论脑安胶囊可以降低卒中的发生率和病死率,改善脑血管功能。在卒中高危人群一级预防中长期疗效优于阿司匹林。

Objective To evaluate the middle- and long-term intervenient effects of Naoan capsule （ a traditional Chinese medicine） on patients with high-risk of stroke . Methods 320 patients with one of the following risk factors, including hypertension, heart disease, diabetes mellitus, lipid abnormality and family history of stroke were screened. All the patients were under 40 years old and their accumulative scores of cerebral vascular hemodynamic indexes （CVHI） were 〈75. The patients were randomly divided into a Naoan group and a aspirin group. The patients of the former group were given Naoan 2 capsules twice a day;the patients of the latter group were given aspirin 100 rag, once a day. The intervenient period was 24 to 36 mouths. The patients were followed up once a year about their blood pressure, lipid, CVHI, as well as the prognosis of the patients. Results （1）The accumulated follow-up time was 470 person-years in the Naoan group, and the morbidity and mortality of stroke were l. 915% and 0. 851% , respectively; The accumulated follow-up time was 460 person-years in the aspirin group, and the morbidity and mortality of stroke were 4. 130% and 2.931%, respectively. The comprehensive morbidity and mortality of stroke in the Naoan group were lower than those in the aspirin group （ P 〈 0.05 ）. （2）the systolic and diastolic pressures beore and after the intervention were 162 ＋11 mm Hg and 130 ＋7 mm Hg, 101 ±9 mm Hg and 83 ±6 mm Hg in the Naoan group, and the CVHI scores were 49 ± 13 and 82 ± 9 ; While those in the aspirin group were 161 - 10 mm Hg and 137 ±5 mm Hg, 99 ±7 mm Hg and 90 ±4 mm Hg, and The CVHI scores of the two groups were 49 ± 12 and 70-11 respectively. （3）Tere were significant differences in the systolic pressure, diastolic pressure, and the CVPI scores between the two groups after the intervention （P 〈 0. 01 ）. Conclusions Naoan capsule may reduce the morbidity and mortality of stroke and improve cerebrovascular function. The long-term efficacy is superior to aspirin for prevention of stroke in high-risk population.