阿加曲班治疗急性脑梗死的有效性和安全性研究

Clinical Study on the Efficacy and Safety of Argatroban on Acute Cerebral Infarction

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:观察急性脑梗死患者48例,采用随机、双盲、双模拟、阳性对照研究。将急性脑梗死患者随机分为阿加曲班注射液组和奥扎格雷钠组,分别用两种药物治疗,用药14d,总观察时间为28d。主要疗效指标采用MESSS评估;次要指标采用ADL评估。结果:(1)阿加曲班组患者治疗后第14天和第28天的主要疗效指标MESSS评分明显低于治疗前(P<0.05或P<0.01);阿加曲班组的次要疗效指标ADL评分也低于治疗前(P<0.01),而奥扎格雷钠组的次要疗效指标与治疗前差异无统计学意义(P>0.05)。(2)阿加曲班组治疗有效率为91.67%,奥扎格雷钠组有效率为87.50%,两组间比较差异无统计学意义(P>0.05)。结果显示两种药物治疗急性脑梗死患者均有较好疗效;阿加曲班组疗效优于奥扎格雷钠组。患者在用药后未出现严重出血反应,无一例因不良事件停药。结论:国产阿加曲班注射液对急性脑梗死有肯定的疗效,对人体无明显的不良反应,是治疗急性脑梗死的安全、有效的药物。

Objective： To evaluate the efficacy and safety of argatroban on acute cerebral infarction. Methods： Forty-eight acute cerebral infarction （ACI） patients were randomly divided into argatroban and sodium ozagrel groups, and were followed up by douhle-blind, double-dummy and positive-controlled study for 14 days with administration and 28 days with observation. Primary efficacy indexes were evaluated by modifed Edinburgh-Scandinavian stroke scale （MESSS）score and secondary efficacy indexes were evaluated by ability of daily living （ADL） score. Results： （1） The scores of MESSS and ADL 14 d and 28 d after treatment in argatroban group significantly decreased than those before treatment （P 〈 0.01）. The scores of MESSS 14 d and 28 d after treatment in ozagrel group significantly decreased than those before treatment （P 〈 0.05）, and there was no significant difference in ADL scores between before and after treatment in argatroban group （P 〉 0.05）. （2） The effective rates were 91.67% and 87.50% in argatroban and ozagrel groups respectively, and there was no significant difference between two groups （P 〉 0.05）. Both of the two drugs were effective on ACI. Argatroban was better than ozagrel. Serious hemorrhage was not seen, and none was discontinued for adverse reaction. Conclusion： Argatroban is effective on ACI without obvious side effect, and it＇s safe and effective.