蕲蛇酶注射液治疗急性脑梗死Ⅲ期临床研究

Phase Ⅲ clinical study of acutase injection in treatment of acute cerebral infarction

目的 通过 期临床试验评价蕲蛇酶注射液治疗急性脑梗死的临床有效性和不良反应。方法 对4 5岁以上 (包括 4 5岁 ) ,发病 1周内的颈内动脉系统脑梗死患者 1346例 ,静脉点滴蕲蛇酶注射液 ( 1ml溶于 5 0 0 ml生理盐水中 ) ,每日一次 ,共 14 d。应用卒中患者临床神经功能缺损程度评分进行临床疗效评定。结果 基本痊愈 17.7% ,显著进步 5 7.9% ,进步 18.6 % ,基本痊愈 +显著进步为 75 .6 % ,基本痊愈 +显著进步 +进步为 94 .2 %。不良反应主要为血小板计数下降 ,停药后绝大部分均可很快自行回升。极个别病例出现轻度的粘膜、皮肤出血及皮疹 ,停药后症状自然消失。未发现严重不良事件。结论 蕲蛇酶注射液是治疗急性脑梗死有效的药物 。

Objective To investigate the clinical efficiency andadverse effects of the Acutase injection in treatment of patients with acute cerebral infaction by carrying out a phase Ⅲ study.Methods Acutase injection (0.75u diluted into 500 milliliter saline) was injected through veins into patients suffering from internal carotid artery thrombosis within one week after the onset,one time daily for 14 days.All patients were older than 45 (including those who were 45 years old).The efficiency was evaluated according tothe revised Edinburgh Scandinavian Stroke Scale established in the National Cerexbrovascular Congress in 1995.The trial was open.Results Therewere 1346 cases enrolled.17.7% patients gained nearly full recovery.57.9% got notable progress.Progress was also observed in 18.6% patients.The three account for 94.2% of all the cases.The major adverse effect was the reduction of blood platelets.By stopping the drug,blood platelets would increased to normal level.Fewpatients experienced slightly bleeding in mucosa and skin.Skin eruptions were also rare.The symptoms disappeared after quitting the drug.No severe adverse effects were observed.Conclusions Acutase injection was efficient intreating acute cerebral infarction just with very slight adverse effects.