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目的 评估降纤酶对急性脑梗死的疗效及安全性。 方法 采用前瞻性、随机、对照试验 ,以东菱精纯克栓酶 ( DF-52 1 )和低分子右旋糖酐为对照组 ,从 1 996年 1月至 1 998年 1 0月共观察 4 81例 ,其中降纤酶组 2 89例 ,东菱组 92例 ,低右组 1 0 0例 ,共完成试验者 30 1例 ,各组份别为 1 4 9例、 70例和 82例 ,于治疗前及治疗后第 1天 ,第 3天 ,第 7天 ,第 1 4天查血浆纤维蛋白原、凝血酶原时间及血小板计数、肝肾功能等。并于治疗前及治疗后 1 ,7,1 4天评估神经功能恢复情况。 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 ,在治疗后 1天已表现出明显效果 ,与日本生产的东菱精纯克栓酶比较疗效相似 ,发病 1 4天治疗总有效率分别为 84 .4 5%和 80 .0 0 %。同时降纤酶组与东菱组治疗后纤维蛋白原下降明显 ,于 7~ 1 4天有回升趋势 ;低右组则无明显变化。 结论 降纤酶具有与东菱精纯克栓酶相似的疗效、副作用小 ,价格明显低于东菱精纯克栓酶。认为国产降纤酶可以取代东菱精纯克栓酶 ,其在脑梗死急性期治疗上具有广泛的前景
Objective To evaluate the efficacy and safety of defibrase in acute cerebral infarction. Methods A prospective, randomized, controlled trial was conducted with DF-521 and dextran as controls. From January 1996 to January 1998, a total of 4 81 patients , Including defibrase group 2 89 cases, Dongling group 92 cases, low right group 1 0 cases, a total of 301 subjects completed the trial, each group was 149 cases, 70 cases and 82 cases, in the treatment Before and after treatment 1 day, 3 days, 7 days, 14 days to check the plasma fibrinogen, prothrombin time and platelet count, liver and kidney function. Neurological recovery was assessed before treatment and on days 1, 7 and 14 after treatment. Results defibrase on acute cerebral infarction significant effect, significantly better than low molecular weight dextran, 1 day after treatment has shown a significant effect, with the production of tamolin sepsis in Japan compared with similar efficacy, the incidence of 14 days of total treatment The effective rates were 84.45% and 80.0% respectively. At the same time defibrase group and Donglin group fibrinogen decreased significantly after treatment, 7 ~ 14 days have a rising trend; low right group had no significant change. Conclusion Defibrase has the same curative effect as Dongling Jing Ke thrombolytic enzyme, the side effect is small, the price is obviously lower than Dongling Jing Ke acre enzyme. Domestic defibrase that can replace East Link fine Keke enzyme, its acute phase in the treatment of cerebral infarction has a wide range of prospects