社区脑卒中高危人群服用脑安胶囊强化干预效果评价

Intensive intervention effect of NAOAN capsule on high-risk stroke populations in communities

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 assess the intensive intervention effect of NAOAN capsule on the primary prevention of stroke in high-risk community populations. Methods A total of 4069 high-risk stroke subjects with their cerebral blood flow scores 〈75,included in this study, were randomly divided into intensive intervention group（n= 2000） and conventional intervention group（n= 2069） with village or neighbourhood committee as a unit according to the principle of informed consent. The subjects were followed up for 2 years during which the occurrence of stroke was observed. Accumulative incidence of stroke was recorded at the end of intervention. Results At the end of intervention,stroke occurred in 52 patients including 18 in intensive intervention group with an accumulative incidence of 0. 9% and 34 in control group with an accumulative incidence of 0. 1643%. The accumulative incidence of stroke was significantly lower in intensive intervention group than in control group（x2 =4. 957,P=0. 026）. Multivariate Cox regression analysis showed that NAOAN capsule could reduce the risk of stroke after adjustment of age, gender and other major risk factors（HR=3. 798,P=0. 001）. Conclusion NAOAN capsule is safe and effective for the primary prevention of stroke in high-risk populations in communities and can reduce its incidence.