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目的 进一步评估降纤酶对急性脑梗死的疗效与安全性 ,我们采用前瞻性、随机、对照试验 ,选用山东烟台北方制药有限公司以尖吻蝮蛇毒为原料生产的降纤酶和低分子右旋糖酐为对照 ,从 1 997年 6月~ 1 998年 1 2月共观察治疗 1 60例急性脑梗死患者 ,其中降纤酶实验组 86例 ,对照组 74例。 方法 研究对象为发病 3天内的急性脑梗死患者 ,年龄在 4 5~ 83岁之间 ,有严格的入选标准。给药方法 :实验组给予降纤酶 1 0 u静滴 ,隔日 1次 ,共 3次。对照组应用低分子右旋糖酐 50 0 ml静滴 ,每日 1次 ,共 1 5次。分别在治疗前和治疗后 1天、 3天、 5天、 >1 4天查血浆纤维蛋白原、血小板计数和凝血酶原时间 ,并在治疗前和治疗后查血脂、血糖和肝肾功能。 结果 降纤酶对急性脑梗死疗效显著 ,明显优于低分子右旋糖酐组 ,3周内治愈率为 71 %,总有效率为 98%。在治疗后 1天便出现明显效果 ,肌力可提高 1~ 2级 ,血浆纤维蛋白原与治疗前比较有显著性差异 ( P <0 .0 0 1 ) ,此差异一直保持在用药后 7天 ,但在 1 4天后差异不具有特异性 ,在治疗中未发现梗死后出血。 结论 降纤酶具有降低血浆纤维蛋白原、抗凝、溶栓、降低全血粘度、抑制红细胞和血小板聚集 ,改善微循环 ,增加红细胞变形能力、抑制炎性物质生成、增强?
Objective To further evaluate the efficacy and safety of defibrase in patients with acute cerebral infarction. We used a prospective, randomized, controlled trial of defibrase and low molecular weight dextran produced by Shandong Yantai North Pharmaceutical Co., Ltd. Control, from June 1997 ~ January 1998 observed and treated 160 cases of acute cerebral infarction patients, including defibrase in experimental group 86 cases, control group 74 cases. Methods The subjects were patients with acute cerebral infarction within 3 days after onset with a mean age of 45 to 83 years and strict criteria of inclusion. Method of administration: experimental group given defibrase 10 u intravenous infusion, every other day, a total of 3 times. Control group of low molecular dextran 50 0 ml intravenous infusion, a total of 15 times a day. Plasma fibrinogen, platelet count and prothrombin time were measured before treatment and 1 day, 3 days, 5 days and> 14 days after treatment, and blood lipid, blood glucose and liver and kidney function were examined before and after treatment. Results Defibrase had a significant effect on acute cerebral infarction and was significantly better than low molecular dextran group. The cure rate was 71% within 3 weeks and the total effective rate was 98%. 1 day after treatment, there was a clear effect, muscle strength can be increased by 1 to 2 levels, plasma fibrinogen compared with before treatment were significantly different (P <0. 01), this difference has been maintained for 7 days after treatment , But the difference was not specific after 14 days and no post-infarction bleeding was found during treatment. Conclusion Defibrase has the functions of reducing plasma fibrinogen, anticoagulant and thrombolysis, reducing whole blood viscosity, inhibiting erythrocyte and platelet aggregation, improving microcirculation, increasing erythrocyte deformability, inhibiting the formation and enhancement of inflammatory substances.