蚓激酶治疗血液流变学异常的缺血性脑血管病患者的Ⅱ期临床试验  

A RANDOMIZED, DOUBLE-BLIND,PLACEB0-CONTROLLED CLINICAL TRIAL OF LUMBROKINASE CAPSULES ON THE PATIENTS OF BLOOD RHEOLOGY DISORDERS WITH ISCHEMIC CEREBROVASCULAR DISEASES

作　　者：王荫华[1] 赵玉宾[1] 陈清棠[1] 

机构地区：[1]北京医科大学第一医院神经内科

出　　处：《中国临床药理学杂志》1997年第2期65-70,共6页The Chinese Journal of Clinical Pharmacology

摘　　要：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。cases with ischemic cerebrovascular diseases caused by blood rheology disorders were treated with lumbrokinase capsules,among them 192 cases were involved in the randomized,double blind, placebo controlled clinical trial of lumbrokinase or placebo group and 112cases were involved in the open clinical trial of lumbroinase group.The results of the randomized, double blind, placebo controlled clinicaltrial revealed that the lumbrokinase capsules (400 mg) could reduce thehemagglutination index, plasma fibrinogen(g/L) whole blood viscosity(mPa·s,230 l/s), plasma viscosity(mPa·s) and could improve the rheology scores and the symptom scores,the difference between the lumbrokinase and placebo groups was significant(P<0.05-0.001); the results of the open clinical trial showed that the lumbrokinase capsules could reduce the dry weight of the thrombosis in vitro, platelet aggregation rate,whole blood viscosity(230,46,5.75 l/S) and could improve the blood rheology scores and symptom scores, the difference between before and after treatment was significant(P<0.05-0.001). The overall effective rates of double blind lumbrokinase group for subjective symptoms and blood rheology disorders of the CVD patients were 84.5% and 91.5% respectively, and of placebo group were 22.2% and 41.3% respectively(P<0.001). Only a few patients had adverse drug reactions and did not take special treatment. It suggests that lumbrokinase is an effective and safe drug for prevention and treatment of ischemic cerebrovascular diseases with blood rheology disorders.

关 键 词：蚓激酶 血液流变学 脑缺血 药物疗法 

分 类 号：R743.310.5[医药卫生—神经病学与精神病学] R973.1[医药卫生—临床医学]