阿加曲班与纤溶酶治疗进展性穿支动脉病变型脑梗死的安全性及疗效评价

Efficacy and Safety Evaluation of Argatroban and Fibrinolytic Enzyme in the Treatment of Progressive Perforator Artery Lesion Type Cerebral Infarction

摘要: 目的：观察阿加曲班治疗进展性穿支动脉病变型脑梗死的临床疗效及安全性。方法：将发病48 h内的95例急性穿支动脉病变型脑梗死患者随机分为试验组和对照组。试验组在常规抗血小板治疗基础上，予以阿加曲班注射液(初始48小时，60 mg/日，24小时持续泵入，后5日，2次/日，每次10 mg，3 h静脉滴注)；后者在常规抗血小板治疗基础上，给予纤溶酶静脉滴注共10日。评价患者治疗前及治疗后1周、2周时美国国立卫生院脑卒中(NHISS)量表评分及3个月随访时改良Rankin (mRS)评分，了解神经功能改变情况及预后。同时行治疗前后的颅脑CT/MRI及血生化、凝血等检查排除不良事件发生(包括症状性颅内出血及其他脏器出血)。结果：阿加曲班组AIS患者治疗1周前后NHISS评分差值明显高于对照组治疗前后NHISS差值；随访3个月后mRS均显著降低(P< 0.05)。阿加曲班组治疗3个月后临床基本痊愈率显著高于对照组。两组治疗1周后复查颅脑CT及凝血等相关化验指标提示均未出现不良事件(P > 0.05)。结论：AIS患者早期应用阿加曲班与纤溶酶均可改善神经系统功能缺损，且两组均不增加不良事件的发生，阿加曲班临床疗效更好。

Abstract: Purpose: To observe the clinical efficacy and safety of argatroban in the treatment of progressive perforator artery lesion type cerebral infarction. Methods: Ninety-five patients with acute perforator artery lesion cerebral infarction within 48 h of onset were randomly divided into experimental group and control group. In addition to conventional antiplatelet therapy, the experimental group was given argatroban injection (60 mg/day for the first 48 hours, pumped continuously for 24 hours, twice a day for the last 5 days, 10 mg for each 3 h intravenously); the latter was given intravenous plasminase for 10 days in addition to conventional antiplatelet therapy. The national Institutes of Health Stroke Scale (NHISS) scores at 1 and 2 weeks before and after treatment and modified Rankin (mRS) scores at 3 months follow-up were evaluated to understand the changes in neurological function and prognosis. At the same time, brain CT/MRI, blood biochemistry and coagulation tests before and after treatment were performed to exclude adverse events (including symptomatic intracranial hemorrhage and other organ bleeding). Results: The NHISS score difference of AIS patients in argatroban group and conventional treatment group was significantly higher than that of control group before and after treatment for 1 week. mRS was significantly decreased after 3 months of follow-up (P < 0.05). After 3 months treatment, the clinical basic recovery rate of argatroban group was significantly higher than that of conventional treatment group. After 1 week of treatment, brain CT and biochemical tests showed no adverse events in both groups (P > 0.05). Conclusion: The early application of argatroban and fibrinolytic enzyme in AIS patients can improve the neurological deficit, and the occurrence of adverse events is not increased in both groups, and the clinical efficacy of argatroban is better.