【摘要】 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。更多还原

【Abstract】 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 double-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.更多还原