【摘要】 目的观察脑心通胶囊对瘀血型缺血性脑卒中患者的二级预防疗效。方法采取随机双盲安慰剂平行对照设计,将319例瘀血型缺血性脑卒中患者分为治疗组161例,对照组158例。治疗组在西医二级预防基础上口服脑心通胶囊,每天2次,每次1.2 g;对照组予以同等剂量安慰剂胶囊。随访日期截止于2017年2月28日。主要疗效指标为再发卒中(包括脑梗死、脑出血、蛛网膜下腔出血)、再发卒中死亡;次要疗效指标为心肌梗死、全因死亡、改良Rankin量表(mRS)评级0~2级构成比。结果两组患者中位随访时间为519天,治疗组脱落11例,对照组脱落10例。治疗组、对照组再发卒中分别为11例、13例,两组比较差异无统计学意义(P>0.05);治疗组及对照组均无脑出血、蛛网膜下腔出血及再发卒中引起的死亡;治疗组、对照组发生心肌梗死分别为0例、1例,两组各有1例发生全因死亡,差异无统计学意义(P>0.05);治疗后治疗组mRS评级0~2级的构成比多于对照组(P<0.05)。结论脑心通胶囊可以提高瘀血型缺血性脑卒中患者预后良好的比例,具有较好的二级预防效果。更多还原

【Abstract】 Objective To explore the effect of Naoxintong Capsule( 脑心通胶囊) on the secondary prevention of ischemic stroke blood stasis type. Methods In this double-blind,placebo-controlled trial,we randomly assigned319 patients with ischemic stroke of blood stasis type into treatment group( 161 cases) and control group( 158 cases). On the basis of secondary prevention of western medicine,the treatment group was given Naoxintong Capsule,2 times a day,1. 2 g per time,while control group used placebo capsule. The follow-up stopped on Febrary28 th,2017. The primary outcomes were stroke including cerebral infarction,cerebral hemorrhage and subarachnoid hemorrhage or death cause of stroke. Secondary outcomes included myocardial infarction,all-cause mortality,changes in the proportion of mRS rating 0 ~ 2. Results The medium follow-up period in two groups was 519 days. There were 11 cases of falling off in the treatment group and 10 cases in the control group. Recurrent stroke occurred in 11 patients in the treatment group and 13 in the control group. There was no statistical significance between two groups( P > 0. 05). There was no cerebral hemorrhage,subarachnoid hemorrhage,and death cause of stroke in both groups.Each group had 1 case of all-cause death and only 1 case in control group had myocardial infarction. The number of myocardial infarction and all-cause death cases both had no statistical significance between groups( P > 0. 05). After treatment,the rate of 0 ~ 2 composition of mRS in the treatment group was more than that of the control group( P <0. 05). Conclusions Naoxintong Capsule is helpful to improve the proportion of good prognosis in patients with ischemic stroke discriminated as blood stasis type,with better secondary prevention effect.更多还原