消栓通络胶囊联合叶酸对缺血性脑卒中二级预防作用临床研究

Secondary prevention of ischemic stroke with the Xiaoshuan Tongluo capsule plus folic acid

目的:探讨消栓通络胶囊联合叶酸对缺血性脑卒中复发高危人群二级预防的临床效果。方法:选择260例缺血性卒中(NIHSS评分≥3分)患者随机分为观察组150例和对照组110例。两组均给予缺血性脑卒中的二级预防措施,在此基础上,观察组口服消栓通络胶囊,6粒/次,3次/d;叶酸片0.8mg/d,1次/d,疗程为1年。随访观察1年,对比两组在治疗后3个月、6个月、1年后的血液流变学变化、血压达标情况,m RS评分、NIHSS评分,以及药物不良反应情况,并观察卒中复发情况。结果:观察组治疗1年后血液流变学各项指标较对照组明显下降(P<0.05或P<0.01);血压达标率较对照组明显增高(P<0.05);m RS评分和NIHSS评分较对照组明显改善(P<0.05或P<0.01);观察组复发率(9.3%)明显低于对照组(28.2%)(P<0.01);观察组和对照组不良反应发生率分别是12.6%和11.8%,差异无统计学意义(P>0.05)。结论:消栓通络胶囊联合叶酸口服可以有效降低血液黏度,有利于控制血压,改善神经功能缺损程度,明显降低脑卒中的复发率。

Objective:To investigate preventive effects of the Xiaoshuan Tongluo capsule plus folic acid on the ischemic stroke of high recurrence risk.Methods:260cases of ischemic stroke(NIHSS≥3)were randomly divided into the observation group(150cases)and control group(110cases).Two groups were given secondary ischemic stroke prevention measures.The observation group was given the Xiaoshuan Tongluo capsule(6capsules a time,3times daily)and folic acid tablets(0.8mg daily,1times daily),for1year.All the cases were followed up for1year.In3months,6months and1year,hemorrheological changes,blood pressure compliance,mRS score,NIHSS score and adverse drug reactions were compared;and recurrence of stroke was observed.Results:For1year,the hemorrheological changes were significantly lower(P<0.05or P<0.01);the compliance rate of blood pressure was significantly higher(P<0.05);the improvement ofMRS and NIHSS scores were more significant(P<0.05or P<0.01);the recurrence rate(9.3%)was significantly lower in the observation group(P<0.01).The incidence of adverse reaction were12.6%and11.8%respectively in the observation group and the control group(P>0.05).Conclusion:The Xiaoshuan Tongluo capsule plus folic acid can effectively reduce the blood viscosity and stroke recurrence rate,control blood pressure,and improve the degree of neurological deficit.