阿加曲班治疗急性缺血性脑卒中的临床研究

The clinical research on argatroban in treating acute ischemic stroke

目的观察阿加曲班治疗急性缺血性脑卒中的临床疗效及安全性。方法采用多中心、随机、开放性临床研究。随机选择发病48 h内的急性缺血性脑卒中患者132例,静脉输入阿加曲班,治疗7 d后观察美国国立卫生研究院卒中量表评分和改良Rankin量表及实验室检查和不良事件发生率。结果与治疗前比较,治疗后患者美国国立卫生研究院卒中量表评分明显降低、改良Rankin量表评分≤2分所占比例明显增高,差异有统计学意义(P<0.05)。试验过程中未发生出血性脑卒中和脑出血等严重不良事件。结论阿加曲班可以改善急性缺血性脑卒中患者的预后及生活质量,具有较高的安全性。

Objective To observe the clinical efficacy and safety of argatroban in treating acute ischemic stroke. Methods The multi center,randomized,open clinical study was used. 132 patients within 48 hours of onset of acute ischemic stroke were randomly selected and were given intravenous injection of argatroban. Seven days later, the National Institutes of Health Scale（NIHSS） score and modified Rankin Scale（mRS） score were observed. Laboratory examination was performed and the incidence of adverse events was observed. Results Compared with before treat- ment,the NIHSS score was significantly lower and the proportion of mRS,2 was increased after treatment,the differences were statistically significant （P 〈 0. 05）. The covariance and central conformity of differences of nerve function defect scores before and after treatment were relatively good. In the course of the experiment, no hemorrhagic cerebral infarction, cerebral hemorrhage and other serious adverse reactions occurred. Conclusion Argatroban could improve the prognosis and the quality of life of patients with acute ischemlc stroke,and has high safety.