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对蕲蛇酶注射液（ａｃｕｔａｓｅｉｎｊｅｃｔｉｏｎ）治疗急性脑梗塞３０９例进行临床安全性及有效性评价。临床试验研究方法采用随机、双盲安慰剂对照及开放试验。疗效评价采用１９９５年全国脑血管病会议制定的“卒中患者临床神经功能缺损程度评分标准”。随机、双盲安慰剂对照试验结果显示：经第一疗程治疗（７ｄ），试验组与对照组总疗效无显著性差异（Ｐ＞０．０５）；而经第二疗程（７ｄ）治疗，试验组有效率为６１．４％；对照组有效率为５５．９％；两组有显著性差异（Ｐ＜０．０１）。试验组及对照组除分别应用试验药及安慰剂外，同时均应用维脑路通２００ｍｇ静脉点滴，每日一次，所以对照组所显示的疗效可能与应用维脑路通有关。开放试验结果表明，第一疗程有效率为４１．３％；第二疗程有效率为７１．５％。本药药物不良反应轻微。试验结果证明蕲蛇酶注射液为治疗急性脑梗塞安全、有效的药物。
309 patients with acute cerebral infarction treated with acutaseinjection were evaluated for clinical safety and efficacy. Clinical Trial Study Methods Randomized, double-blind placebo-controlled and open-label trials. Efficacy evaluation using the 1995 National Conference on cerebrovascular disease developed “stroke clinical neurological deficit score.” The results of randomized, double-blind placebo-controlled trial showed that there was no significant difference between the two groups (P> 0.05) after the first course of treatment (7d) The effective rate was 61.4% in the control group and 55.9% in the control group. There was significant difference between the two groups (P <0.01). In addition to the experimental group and the control group were used in addition to the test drug and placebo, at the same time Weiweilutong 200mg intravenous drip once a day, so the control group showed efficacy may be related to the application of Venoruton. Open trial results showed that the first course of treatment was effective 41.3%; the second course of treatment was 71.5%. The drug adverse reactions mild. Test results show that Acutobin injection for the treatment of acute cerebral infarction safe and effective drug.