血栓通胶囊治疗脑梗死(瘀血阻络证)的多中心临床研究

Multicentre clinical study on Xueshuantong Capsules in treatment of cerebral infarction(syndrome of blood stasis obstructing collaterals)

目的探讨血栓通胶囊治疗脑梗死(瘀血阻络证)的临床疗效。方法选择2011年11月—2012年11月在黑龙江中医药大学附属第二医院等6家医院就诊的恢复期脑梗死(瘀血阻络证)患者201例,随机分为对照组(51例)和治疗组(150例)。对照组口服银杏叶胶囊,2粒/次,3次/d。治疗组口服血栓通胶囊,2粒/次,3次/d。两组患者均治疗4周。观察两组的临床疗效,比较两组的美国国立卫生研究所卒中量表(NIHSS)评分、日常生活能力量表(ADL)评分和改良Rankin量表情况。结果治疗后,对照组和治疗组的中医证候、偏身麻木、头痛、头晕治疗总有效率分别为74.51%、98.33%,55.26%、74.34%,88.89%、94.51%,69.23%、87.50%,两组比较差异有统计学意义(P<0.05)。治疗后,两组NIHSS评分均显著下降,ADL评分均显著上升,同组治疗前后比较差异有统计学意义(P<0.05);且治疗组这些观察指标的改善程度明显优于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组改良Rankin量表的0、1、2级的比例均显著上升,3、4、5级均显著下降,同组治疗前后比较差异有统计学意义(P<0.05)。结论血栓通胶囊治疗脑梗死(瘀血阻络证)具有较好的临床疗效,可改善临床症状,提高生活质量,且安全性较好,具有一定的临床推广应用价值。

Objective To evaluate the clinical efficacy of Xueshuantong Capsules in treatment of cerebral infarction （syndrome of blood stasis obstructing collaterals）. Methods Patients （201 cases） with convalescent cerebral infarction in 6 hospitals, such as the Second Affiliated Hospital of Heilongjiang University of Chinese Medicine from November 2011 to November 2012 were randomly divided into the control group （51 cases） and the treatment group （150 cases）. Patients in the control group were po administered withYinxingye Capsules, 2 grains/time, three times daily. Patients in the treatment group were po administered with Xueshuantong Capsules, 2 grains/time, three times daily. Patients in two groups were treated for 4 weeks. After treatment, the clinical efficacies were evaluated, and NIHSS scores, ADL scores, and modified Rankin scale in two groups were compared. Results After treatment, symptom efficacies of Traditional Chinese Medicine, hemianesthesia efficacies, headache efficacies, and dizzy efficacies in the control and treatment groups were 74.51% and 98.33%, 55.26% and 74.34%, 88.89% and 94.51%, 69.23% and 87.50%, respectively, and there was difference between two groups （P 〈 0.05）. After treatment, the NIHSS scores in two groups were significantly decreased, but the ADL scores in two groups were significantly increased, and the difference was statistically significant in the same group （P 〈 0.05）. And the observational indexes in the treatment group were significantly better than those in the control group, with significant difference between two groups （P 〈 0.05）. After treatment, the proportion of 0, 1, and 2 grade of modified Rankin scale in two groups were significantly increased, but the proportion of 3, 4, and 5 grade of modified Rankin scale in two groups were significantly decreased, and the difference was statistically significant in the same group （P 〈 0.05）. Conclusion Xueshuantong Capsules has clinical curative effect in treatment of cerebral infarction （syndrome of blood stasis obstructing collaterals）, can improve clinical symptoms, and raise the quality of life, with good safety, which has a certain clinical application value.