脑安胶囊与阿司匹林预防卒中的随机对照试验

Naoan capsule and aspirin in the prevention of stroke:a randomized controlled trial

目的评价脑安胶囊与阿司匹林预防卒中的效果。方法以多中心的形式,在基线调查时筛检出≥40岁、有卒中危险因素暴露和血流动力学异常的卒中高危个体4415例,以村和居委会为单位随机分为脑安胶囊组(1656例),阿司匹林50(1348例)、75mg组(1411例)。3组在指导一般干预措施的基础上,分别给予相应的干预药物,阿司匹林两组分别口服阿司匹林50、70mg,1次/d;脑安胶囊组口服脑安胶囊1～2粒/次,2次/d。平均干预16个月。随访观察卒中的发病,比较各组发病率的差异。结果脑安胶囊组,阿司匹林50、75mg组的卒中发病率分别为6.43、12.92和10.37(1000-1.人年-1)。脑安胶囊组卒中发病率显著低于阿司匹林50mg组(P=0.035),分别比阿司匹林50、75mg组下降了50.2%和38.0%。3个干预组复查时收缩压和舒张压较基线水平均下降,P<0.01。药物不良反应脑安胶囊组较阿司匹林组轻。结论脑安胶囊对卒中高危个体的干预效果优于阿司匹林。

Objective To evaluate the efficacy of naoan capsule and aspirin in the prevention of stroke so as to provide theoretical basis for stroke prevention. Methods A total of 4415 individuals at high risk of stroke aged ≥ 40 years, who had exposure to stroke risk factors and hemodynamic abnormalities, were screened from a baseline investigation in a multicenter randomized controlled trial. They were randomly allocated into naoan capsule （ n= 1656）, 50 mg aspirin （ n = 1348 ） and 75 mg aspirin （ n = 1411 ） groups according to villages or communities. Intervention medications were given to the three groups on the basis of general intervention guidelines. The two aspirin groups were given aspririn 50 nag and 75 nag respiratively （Po, Qd）, and naoan group was given 1 -2 capsules （Po, Bid）. The mean intervention medications time was 16 months. The onset of stroke was observed during the follow-up period, and the differences of inci- dence in all groups were compared. Results The incidence of stroke in the naoan capsule, 50 mg aspirin and 75 mg aspirin groups were 6. 43, 12. 92 and 10. 37 per 1000 person-years, respectively. The incidence of stroke in the naoan capsule group was significantly lower than that in the 50 mg aspirin group （P 〈0. 035） and decreased by 50. 2% and 38. 0% respectively as compared with the 50 mg and 75 mg aspirin groups. Conclusion The interventional effect of naoan capsule is superior to aspirin in individuals at high risk of stroke.