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对304例缺血性脑血管病的血液流变学异常患者,进行了蚓激酶胶囊的随机双盲对照临床试验(192例)和开放临床试验(112例)。随机双盲对照临床试验结果表明:蚓激酶胶囊(400mg)可降低红细胞聚集指数,血浆纤维蛋白原(g/L),全血粘度(mPa·S,高切变率),血浆粘度(mPa·S),并改善血液流变学积分和患者的自觉症状积分,与安慰剂组的差异有显著性(P<0.05-0.001);开放试验结果表明:蚓激酶胶囊可降低血栓干重、血小板聚集率、全血粘度(高、中、低切变率),并改善患者血液流变学积分和患者自觉症状积分,治疗前后的差异有显著性(P<0.05-0.001)。双盲组蚓激酶治疗患者自觉症状和血液流变学异常的总有效率分别为84.5%和91.5%,安慰剂组分别为22.2%和41.3%(P<0.001)。仅少数患者有不良反应,无需特殊处理。说明蚓激酶是一种防治缺血性脑血管病中血液流变学异常的安全有效的药物。
Randomized double-blind controlled clinical trial (192 cases) and open clinical trial (112 cases) of lumbrokinase capsules were performed on 304 patients with abnormal hemorheology of ischemic cerebrovascular disease. Randomized double-blind controlled clinical trial results showed that lumbrokinase capsule (400 mg) could reduce erythrocyte aggregation index, plasma fibrinogen (g / L), whole blood viscosity (mPa · S, high shear rate), plasma viscosity (P <0.05-0.001). The results of open trial showed that lumbrokinase capsules could reduce the number of thrombus Weight, platelet aggregation rate, whole blood viscosity (high, middle and low shear rate), and to improve the patient’s hemorheological score and patient’s symptom score, the difference was significant before and after treatment (P <0.05-0. 001). The total effective rate of patients with symptoms and hemorheology abnormalities was 84.5% and 91.5% in the double-blind group and 22.2% and 41.3% in the placebo group (P <0. 001). Only a few patients have adverse reactions, without special treatment. Lumbrokinase is a safe and effective drug for preventing and treating abnormal blood rheology in ischemic cerebrovascular disease.