蚓激酶胶囊治疗脑梗死患者的疗效和安全性

The efficacy and safety of lumbrokinase capsule in treatment of cerebral infarction

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 study the efficacy and safety of lumbrokinase capsule in treatment of cerebral infarction. Methods:73 patients were enrolled into the multi-center,randomized,double blind, and controlled study. Patients were treated with lumbrokinase capsule after 3 weeks onset of infarction. Blood samples were taken over time to evaluate its efficacy. Results: After 28d of treatment, the pro-thrombin time(PT) and activated partial thromboplastin time(APTT) were prolonged,fibrinogen and plasminogin activator inhibitor(PAI) were decreased,D-dimer and tissue plasminogen activator(t-PA) were increased, and the viscosity of blood and plasma were improved in active group and there were significant difference between 2 groups. Neural function deficit evaluation indicated that there was improvement in both groups but more pronounced in active group. Total effective rate was 88% for active group and 47.8% for control group. 1 case of mild gastrointestinal tract hemorrhage occurred in active group.Conclusion: Lumbrokinase capsule is effective and safe in treatment and prevention of cerebral infarction.