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目的在Ⅱ期临床试验初步有效基础上,进一步验证人尿激肽原酶治疗急性脑梗死的有效性和安全性。方法多中心随机双盲安慰剂3:1平行对照设计;起病48h 内急性脑梗死患者为入选对象;剂量为0.15 PANU/d 慢速静脉点滴,共3周。结果共入组466例,完成意向治疗数据集分析的446例,其中治疗组330例,对照组116例。治疗前两组基线差异无统计学意义。治疗1周时,治疗组欧洲卒中量表(ESS)增分率已优于对照组;3周时治疗组 ESS 较治疗前增加55.1%±33.0%,而对照组增加44.7%±32.8%,P=0.0022;等级疗效有效率治疗组为71.21%,对照组为52.59%,两组比较,Fisher 确切概率 P=0.0004。3个月回访者374例,治疗组(280例)中 Barthel 指数≥50者高于对照组(94例),P=0.0228。与试验药物肯定有关或可能有关的不良反应发生率为7.74%。4例严重不良反应,其中2例死亡,但判定与研究药物无关;另2例发生血压突然下降,考虑与合用血管紧张素转换酶抑制剂和尤瑞克林滴速过快有关,及时给予升压药物后,血压很快回升,未留不良后果。其他不良反应有恶心呕吐、胸闷心慌、头胀痛、脸潮红、心悸等,程度较轻,多数无需特殊处理。结论尤瑞克林能有效地改善急性脑梗死的神经功能缺损。
Objective To further validate the clinical efficacy and safety of human urokinase in the treatment of acute cerebral infarction. Methods A multicenter randomized, double-blind, placebo-controlled, 3: 1, parallel-controlled design was performed. Patients with acute cerebral infarction within 48 hours of onset were enrolled. Slow intravenous drip of 0.15 PANU / d was given for 3 weeks. Results A total of 466 patients were enrolled in the study, and 446 patients completed the intention-to-treat dataset analysis, including 330 in the treatment group and 116 in the control group. There was no significant difference between the two groups before treatment. At 1 week, ESS score of the treatment group was higher than that of the control group. At 3 weeks, ESS of the treatment group increased by 55.1% ± 33.0% compared with that of the control group, while that of the control group increased by 44.7% ± 32.8%, P = 0.0022; The effective rate of grade in the treatment group was 71.21% and that in the control group was 52.59%. The exact probability of Fisher was P = 0.0004.3 months in the two groups, 374 cases were returned, Barthel index≥50 in the treatment group (280 cases) Higher than the control group (n = 94), P = 0.0228. The incidence rate of adverse reactions affirming or possibly related to the test drugs was 7.74%. 4 cases of serious adverse reactions, including 2 deaths, but the judge and the study drug has nothing to do; the other two cases of sudden drop in blood pressure, consider the combination of angiotensin converting enzyme inhibitors and uriclin rapid drip rate, timely administration of l Pressure drugs, the blood pressure rose quickly, leaving no adverse consequences. Other adverse reactions are nausea and vomiting, chest tightness, palpitation, head pain, flushing, palpitations, etc., to a lesser extent, most without special treatment. Conclusion Youre Kelin can effectively improve the neurological deficits in acute cerebral infarction.