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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的干预效果。方法采用多中心、随机对照研究,筛选出脑血管血流动力学分值<75分的脑卒中高危人群4069例作为干预对象。根据知情同意原则,以村或居委会为单位随机分为强化干预组2000例和一般干预组2069例。2组干预观察2年,随访脑卒中发病情况。评价指标为干预结束时,2组脑卒中累积发病率。结果干预结束时,2组共新发生脑卒中52例,强化干预组新发生脑卒中18例,脑卒中累积发病率为900人/10万人。一般干预组新发生脑卒中34例,发病率为1643人/10万人。与一般干预组比较,强化干预组脑卒中累积发病率明显降低,差异有统计学意义(X~2=4.957,P=0.026)。采用多因素Cox回归分析,在调整了年龄、性别及其他几种主要危险因素后,服用脑安胶囊可降低脑卒中发病风险(HR=3.798,P=0.001)。结论在社区脑卒中高危人群中应用脑安胶囊进行脑卒中一级预防是安全有效的,可以降低脑卒中发病率。
Objective To evaluate the intervention effect of traditional Chinese medicine Na’an Capsule in primary stroke prevention in community high risk stroke population. Methods A multicentre, randomized and controlled study was conducted to select 4069 high risk stroke patients with cerebrovascular hemodynamic score <75 points as the intervention target. According to the principle of informed consent, villages and neighborhood committees were randomly divided into intensive intervention group (2000 cases) and general intervention group (2069 cases). Two groups of interventions observed for 2 years, followed up the incidence of stroke. The evaluation index was the cumulative incidence of stroke in the two groups at the end of the intervention. Results At the end of the intervention, 52 new strokes occurred in two groups and 18 new strokes in the intensive intervention group. The cumulative incidence of stroke was 900 per 100,000. In the general intervention group, 34 new strokes occurred, the incidence rate was 1643 people / 100000 people. Compared with the general intervention group, the cumulative incidence of stroke in the intensive intervention group was significantly lower, with significant difference (X ~ 2 = 4.957, P = 0.026). Multivariate Cox regression analysis showed that administration of Na’an Capsule reduced the risk of stroke after adjusting for age, gender and other major risk factors (HR = 3.798, P = 0.001). Conclusion It is safe and effective to use primary brain capsule for primary prevention of stroke in community high risk stroke population and reduce the incidence of stroke.