大活络丸预防脑梗死再发临床疗效观察

Observation on the effect of Dahuoluo Pills in preventing the recurrence of cerebral infarction

目的观察同仁堂大活络丸预防脑梗死再发的效果,探讨可能的作用机理。方法将脑梗死(中医辨证为风痰瘀阻型)患者81例随机分为治疗组41例与对照组40例,住院期间2组均按脑梗死常规基础治疗,包括抗血小板凝集、控制血压、控制血糖、调脂等,出院后2组均用阿司匹林肠溶片(晚间睡前75 mg)和阿托伐他汀片(每天10 mg)治疗,治疗组加用同仁堂大活络丸(每丸3.6 g,每次1丸,每天2次),治疗20天,停10天,以1年为观察期。1年后比较2组神经功能缺损评分、日常生活能力评分、血流变学指标改变、血脂改变、脑梗死再发率。结果有效病例2组各39例,观察1年后,2组的神经功能缺损评分、日常生活能力评分、中风病类诊断评分均有改善,治疗组评分改善优于对照组(P<0.05);血流变指标改善,治疗组在全血高切黏度、全血低切黏度、红细胞压积、血沉方程K值均有显著改善(P<0.05),血浆黏度改善尤为显著(P<0.01),对照组除红细胞压积改善明显(P<0.05),其他项目无显著改善;血脂改善情况,2组用药1年后三酰甘油、胆固醇、高密度脂蛋白、低密度脂蛋白均有显著改善(P<0.05),且治疗组改善优于对照组(P<0.05),脑梗死再发率治疗组低于对照组(P<0.05)。治疗组5例用药期间出现口干舌燥,停药后消失。结论大活络丸改善脑梗死神经功能缺损、提高日常生活能力、改善血流变指标、降低血脂、预防脑梗死再发有良好效果。

Objective To observe the eff ect of Dahuoluo Pills produced by Tongrentang in preventing the recurrence of cerebral infarction,and to explore its possible mechanisms.Methods A total of 81 patients with cerebral infarction(differentiated as the syndrome of blockade of wind-phlegm-static blood of TCM)were randomly divided into a treatment group(n=41)and a control group(n=40).During hospitalization,both groups received a conventional basic treatment for cerebral infarction,including anti-platelet agglutination,blood pressure control,blood glucose control,lipid regulation,etc.After discharge,they were both treated with aspirin enteric-coated tablets(75 mg before bedtime)and atorvastatin tablets(10 mg daily),while the treatment group was additionally treated with Tongrentang Dahuoluo Pills(3.6 g per pill,1 pill per time,twice a day),which suspended for 10 days after being administered for 20 days,and the observation period was one year.One year later,the neurological defi cit scores,daily living ability scores,changes in hemorheological indexes,changes in blood lipid and recurrence of cerebral infarction were compared between the two groups.Results There were 39 eff ective cases in each group.After one year of observation,the scores of neurological defi cit,daily living ability,and stroke diagnosis were improved in both groups,and the improvement in the treatment group was better than that in the control group(P<0.05).With regard to the hemorheological indexes,the whole blood high shear viscosity,whole blood low shear viscosity,hematocrit and the K value of ESR equation were significantly improved in the treatment group(P<0.05),and the plasma viscosity was especially improved significantly(P<0.01).In the control group,except hematocrit(P<0.05),there was no significant improvement in other items.With respect to the blood lipid,the indexes of triacylglycerol,cholesterol,high-density lipoprotein,and low-density lipoprotein were all signifi cantly improved in the two groups one year after treatment(P<0.05),and the improvement in the treatment group was better than that in the control group(P<0.05),and the recurrence rate of cerebral infarction was lower(P<0.05).Dry mouth occurred in 5 cases in the treatment group during the medication period,and disappeared during the withdrawal period.Conclusion Dahuoluo Pills has a good effect in improving neurological defi cit,daily living ability,hemorheological indexes,reducing blood lipid and preventing recurrence of cerebral infarction.