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本文为一多中心、前瞻性、随机、对照、开放试验,评价东菱精纯克栓酶(DF─521)对中国人急性脑梗塞161例的疗效,并与用低分子右旋糖酐132例者进行比较。结果显示:DF─521组的功能恢复程度明显优于低右组(P<0.001)。且从治疗后1d即出现明显效果,并可明显降低血纤维蛋白原水平,治疗10dCT扫描低密度灶体积比治疗前缩小范围较对照组明显。在治疗过程中DF─521组未出现明显的不良反应,治疗10d的总有效率DF─521为82.6%,对照组为59%。
This multicenter, prospective, randomized, controlled, open-label trial evaluated the efficacy of DF-521 in 161 Chinese patients with acute cerebral infarction and was associated with 132 patients with low molecular weight dextran Compare The results showed that the functional recovery of DF-521 group was significantly better than that of the low right group (P <0.001). And obvious effect was found on the 1st day after treatment, and the level of fibrinogen was obviously decreased. The volume of low density lesion treated by 10dCT was smaller than that of the control group before treatment. During the course of treatment, there was no obvious adverse reaction in DF-521 group. The total effective rate of DF-521 was 82.6% after 10 days and 59% in control group.