目的 评价在社区脑卒中高危人群中应用中药脑安胶囊进行脑卒中一级预防对脑血管功能的改善效果.方法 采用多中心、随机对照研究方法,在北京、上海、长沙、成都的社区人群中筛查出1 088例脑卒中高危人群(经改良的Framingham卒中风险预测量表评估,10年卒中风险≥6%,同时脑血管功能积分值<75分者),以村或居委会为单位随机分为脑安胶囊组和阿司匹林组,脑安胶囊组559例,阿司匹林组529例,对其进行2个月1次的随访管理,为期2年,分析比较两组干预期间和干预结束时脑血管功能的改善情况.结果 最终进入统计分析的脑安胶囊组531例,阿司匹林组465例.干预2年结束时,脑安胶囊组脑血管功能积分值从基线的(45.2±19.7)分提高到(61.7±26.5)分(t=-12.931, P<0.01),阿司匹林组脑血管功能积分值从基线的(47.2±18.9)分提高到(53.7±25.1)分(t=-5.058,P<0.01);干预2年结束时,脑安胶囊组的脑血管功能积分值平均水平明显高于阿司匹林组(t=4.906, P<0.01).结论 在脑卒中高危个体的健康管理中,长期服用脑安胶囊可有效改善脑卒中高危个体的脑血管功能,并且效果优于阿司匹林.“,”Objective To evaluate the efficacy of the traditional Chinese medicine NAOAN capsule in primary prevention of stroke in high?risk populations. Methods A multicenter, randomized controlled study was performed in community setting, involving 1 088 individuals at high risk of stroke, with cerebrovascular function scores<75 and 10?year Framingham stroke risk ≥6%. Subjects were recruited in communities at Beijing, Shanghai, Changsha, and Chengdu communities, through resident committees or the village unit. A total of 559 subjects were randomized into a group treated with the NAOAN capsule, and 529 subjects in an aspirin treatment group. Follow?up was performed every 2 months for 2 years. At the mid?point and end of the intervention, we compared cerebrovascular function differences between the 2 groups. Results During the 2?year community trial, 531 subjects in the NAOAN capsule group and 465 in the aspirin group followed the protocol. Cerebrovascular function scores increased from 45.2±19.7 at baseline to 61.7±26.5 after the 2?year trial (t=－12.931, P<0.001) in the NAOAN capsule group, and from 47.2±18.9 at baseline to 53.7 ± 25.1 (t=－5.058, P<0.001) in the aspirin group; greater increases in cerebrovascular function scores were found in the NAOAN capsule group than that in the aspirin group (t=4.906, P<0.001). Conclusions Cerebrovascular function in individuals at high risk of stroke was improved by taking NAOAN capsule. Cerebrovascular function scores improved more with NAOAN capsules than with aspirin.