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目的:评价蚓激酶胶囊治疗脑梗死的疗效和安全性。方法:采用多中心、随机双盲、安慰剂对照(2:1)临床试验设计,73例发病3周后用药的脑梗死患者,分治疗组(n=50)和对照组(n=23),分别口服蚓激酶肠溶胶囊60万U和安慰剂2粒,tid,给药28d。统一实验室检测病例的凝血、纤溶、血液流变学指标,并评价患者的神经功能缺损和生活能力缺损程度。结果:治疗28d后,治疗组凝血酶原时间(PT)和部分凝血活酶时间(APTT)延长;纤维蛋白原(Fg)降低,D-二聚体含量增加;组织型纤溶酶原激活物(t-PA)含量提高,纤溶酶原激活物抑制物(PAI)含量降低;血浆黏度和全血黏度改善,且均具有显著性。安慰剂对照组则改变不明显。临床神经功能缺损评价,2组均有改善,但是治疗组恢复明显,治疗组有效率为88％,对照组47.8％。73例患者中,治疗组出现1例轻度上消化道出血(2％),无肝肾功能影响。结论:百奥蚓激酶胶囊治疗脑梗死安全有效,可作为治疗和预防缺血性脑血管病的有效药物。
Objective: To evaluate the efficacy and safety of lumbrokinase in the treatment of cerebral infarction. METHODS: A multicenter, randomized, double-blind, placebo-controlled (2: 1) clinical trial was designed and 73 patients with cerebral infarction treated 3 weeks later were divided into treatment group (n = 50) and control group , Respectively, oral administration of Lumbrokinase enteric-coated capsules 600,000 U and placebo 2 tablets, tid, administration 28d. Uniform laboratory test cases coagulation, fibrinolysis, hemorheology indicators, and evaluation of patients with neurological deficits and the extent of the ability to defect. Results: Prothrombin time (PT) and partial thromboplastin time (APTT) were prolonged in the treatment group after treatment for 28 days. The levels of fibrinogen (Fg) and D-dimer were increased in the treatment group. Tissue plasminogen activator (t-PA) content, plasminogen activator inhibitor (PAI) content decreased; plasma viscosity and whole blood viscosity improved, and were significant. The placebo control group did not change significantly. Evaluation of clinical neurological deficit, two groups have improved, but the treatment group recovered significantly, the effective rate was 88% in the treatment group, 47.8% in the control group. Among the 73 patients, one case of mild upper gastrointestinal bleeding (2%) in the treatment group had no effect on liver and kidney function. CONCLUSION: Hundred lupus kinase is safe and effective in the treatment of cerebral infarction and can be used as an effective drug in the treatment and prevention of ischemic cerebrovascular disease.