阿加曲班治疗急性缺血性脑卒中的有效性及安全性

摘要

Objective To evaluate the effectiveness and safety of argatroban made in China in treatment of acute cerebral in -farction .Methods 106 patients were divided into study group and control group randomly , 53 patients in each group , Patients in the control group were treated by conventional therapy , such as low molecular dextran, nimodipine, citicoline sodium, and asprin.Ar-gatroban was used in the study group in addition to conventional therapy for 7days.The patients in all groups were observed for another 7days after treatment.NIHSS score was used to evaluate the clinical effect .The changes in aspartate aminotransferase (ALT), pro-thrombin time(PT), activated partial thromboplastin time (aPTT), blood platelet (PLT) count were used to evaluate the safety. Results There was significant decrease of neurologic impairment scores in study group after treatment for 7 days and 14 days compared with before treatment [(9.28 ±3.25) vs (14.22 ±4.27);(7.61 ±2.44) vs (14.22 ±4.27), P<0.05].The post-treatment neu-rologic impairment scores in the study group were low compared with the control group after treatment for 7 days and 14 days [(9.28 ± 3.25) vs (11.86 ±3.58)];[(7.61 ±2.44) vs (9.40 ±3.45)],P<0.05) .There were no difference in ALT, PT, aPTT, and PLT before and after treatment in both groups .Conlusions Argatroban is effective for the acute cerebral ischemic stroke and has no obvious bleeding tendency and other side effects .Argatroban is worthy of wide use in cerebral ischemic stroke .%目的：评价国产阿加曲班注射液治疗急性脑梗死的有效性及安全性。方法将106例急性缺血性脑卒中患者随机分为治疗组和对照组，每组各53例，对照组用常规治疗方法（右旋糖酐-40、尼莫地平、胞磷胆碱钠、阿司匹林等），治疗组在常规治疗的基础上加用阿加曲班，用药7 d，总观察时间为14 d。依据NIHSS评分进行临床疗效评价，检测肝功能（ ALT）、凝血功能（PT、aPTT）、血小板计数（PLT）的变化评价其安全性。结果治疗组第7天（9．28±3．25）和第14天（7．61±2．44） NIHSS评分均显著降低，与治疗前（14．22±4．27）比较，差异有统计学意义（P＜0．05）；与对照组第7天（11．86±3．58）、第14天（9．40±3．45）相比，差异有统计学意义（P＜0．05）。两组治疗后ALT、PT、aPTT和PLT与治疗前比较，差异无统计学意义。结论阿加曲班治疗急性缺血性脑卒中临床效果确切，无明显出血倾向及不良反应，值得推广。