蕲蛇酶注射液治疗急性脑梗塞的临床评价

A CLINICAL STUDY OF ACUTASE INJECTION IN TREATMENT OF ACUTE CEREBRAL INFARCTION

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。

This paper was a clinical study of acutase injection in treatment of patients with acute cerebral infarctions, including 200 cases of randomized, double_blind, placebo controlled clinical trial, and 209 cases of open trial. Acutase injection was produced by Sanming Pharmaceutical Company, Fujian Province. The efficacy was evaluated by the revised Edinburgh Scandinavian Stroke Scale, established in the National Cerebrovascular Congress, 1986. The results revealed in double-blind trialno significant difference between the study group and the control group after the first course of treatment (7 days ), but a significant difference was found after 2 courses of treatment (14 days). The efficacy rate of the study group was 61.4%, and the control group was 55.9% (P<0.01). Since we treated each patient with troxerutin 200 mg intravenously per day after the intravenous infusion of acutase in both groups, the efficacy rate in the control group might be related to the efficacy of troxerutin. In the open trial, the efficacy rate was 41.3% after the first course of treatment, and the efficacy rate was 71.5% after the second course of treatment. Only mild adverse effects were found. It suggests acutase is an effective and safe drug in treatment of acute cerebral infarction.