摘要
目的 本文通过随机、对照、开放性临床研究,对海王降纤酶治疗急性脑梗死的有效性及安全性进行评价。方法 将90例急性脑梗死病人按2:1随机分为试验组和对照组,两组均以低分子右旋糖酐作为基础治疗。试验组加用降纤酶静脉给药,首剂量10 IU,其后5 IU隔日1次,共3次,总剂量20 IU。结果 与对照组比较,降纤组治疗后血浆FIB水平明显下降(P<0.001)。在降纤治疗过程中,有2例颅内出血发生,没有死亡病例,两组出血的差异无显著性。治疗后14天神经功能缺损恢复程度明显优于对照组(P<0.01)。结论 降纤酶是一种治疗急性脑梗死较为安全有效的药物。
Objective To evaluate the safety and efficacy of defibrase in the treatment of acute cerebral infarction by a randomized, controlled and opened clinical trial. Methods Ninety patients with acute infarction were randomly divided into the test group and the control group. The patients in each group were treated with dextran injection as a basic treatment. In the test group all patients received an initial intravenous infusion of defibrase 10 IU and a subsequent dose of 5 IU every other day for 3 times altogether. The total dose was 20 IU. Results The level of plasma FIB in the test group was remarkably declined after treatment comparing with the control group ( P < 0.001). In the course treating with defibrase, intracranial hemorrhage occurred in two cases, but nobody die. However, there were no statistical significant difference in bleeding events between the two groups. The neurological function of the test group recovered significantly better than that of the control group after 14 days defibrase treatment. Conclusions Defibrase is a safe and effective drug for the treatment of acute cerebral infarction.
出处
《神经疾病与精神卫生》
2001年第3期22-24,共3页
Journal of Neuroscience and Mental Health