阿加曲班对比阿司匹林联合氯吡格雷治疗急性缺血性卒中的初步随机、开放研究  

Argatroban versus aspirin plus clopidogrel in the treatment of acute ischemic stroke: a pilot, randomised, open-label study

作　　者：刘梦婵[1,2] 李凤鹏[3] 韩雅玲[4] 陈会生[3] 

机构地区：[1]大连医科大学研究生院,大连116000 [2]南昌大学第三附属医院神经内科 [3]沈阳军区总医院神经内科,沈阳110840 [4]沈阳军区总医院心内科,沈阳110840

出　　处：《解放军医学杂志》2015年第6期433-439,共7页Medical Journal of Chinese People's Liberation Army

基　　金：辽宁省科技攻关计划(2013225089);科技部重大新药创制创新药物研究开放技术平台建设项目(2012ZX0903016-002)~~

摘　　要：目的比较阿加曲班与阿司匹林联合氯吡格雷治疗急性缺血性卒中的临床疗效和安全性。方法将48h内发病的75例急性缺血性卒中患者随机分为两组:阿加曲班组(入组35例,最终完成试验31例)和阿司匹林联合氯吡格雷双抗组(简称双抗组,入组40例,最终完成试验36例)。治疗前评估OCSP分型,采用NIHSS评定患者神经功能缺损程度、采用Barthel指数(BI)评定日常生活活动能力(ADL),1周时复评NIHSS,3个月时随访ADL并进行改良Rankin(mRS)评分,了解短期内神经功能改善情况及3个月的疗效评价。治疗前完善颅脑影像学、肝肾功能、血常规、凝血等生化指标,1周后复查前述指标,观察出血及生化指标变化情况。治疗期间观察用药相关不良反应。出院前完善TOAST病因学分析。结果 (1)阿加曲班组及双抗组急性脑梗死患者治疗1周后NIHSS评分较治疗前均降低,随访3个月ADL水平升高,组内比较差异有统计学意义(P<0.01),两组间比较差异无统计学意义(P>0.05)。阿加曲班组6例及双抗组5例中高危短暂性脑缺血发作(TIA)患者,住院及随访期间发作次数较入院前明显减少,复查颅脑CT或MRI,阿加曲班组3例、双抗组2例进展为脑梗死,均为无症状性脑梗死。(2)阿加曲班组与双抗组治疗1周后复查颅脑影像学及相关化验指标,与治疗前比较,均未见明显出血事件(包括颅内出血及其他脏器出血)及肝肾功能损害(P>0.05)。(3)两组患者OCSP分型以部分前循环梗死(PACI)、腔隙性梗死(LACI)、后循环梗死(POCI)为主,TOAST病因学分析以大动脉粥样硬化(LAA型)及小动脉闭塞(SAO型)为主,各组治疗后神经功能缺损情况均较前改善,未见明显出血事件。比较阿加曲班组及双抗组前、后循环梗死患者1周NIHSS评分,两组在前循环梗死中无明显差异,阿加曲班组在后循环梗死患者中显示出更好的疗效趋势。结论阿加曲班抗凝与阿司匹林联合氯吡格�Objective To evaluate the efficacy and safety of argatroban versus aspirin plus clopidogrel in the treatment of acute ischemic stroke. Methods Seventy five patients with acute ischemic stroke within 48 h of symptom onset were randomly divided into two groups： argatroban group（argatroban was used for 7 days according to the instructions, followed by aspirin 100 mg per day plus clopidogrel 75 mg per day until discharge, n=35）, and combination antiplatelet group（300mg of clopidogrel for the first day, then 75 mg daily plus aspirin 100 mg daily until discharge, n=40）. Oxfordshire Community Stroke Project（OCSP） classification was assessed in patients before treatment. National Institutes of Health Stroke Scale（NIHSS） was used for rating neurological deficit score of patients, and Barthel index for rating activities of daily life（ADL）, and modified Rankin scale for handicap score. NIHSS was assessed one week after enrollment, while ADL and m RS assessment were recorded 3 months after onset. Brain imaging, liver and kidney function, blood routine tests and blood coagulation capacity of the patients were measured before and one week after enrollment to observe changes in hemorrhage and biochemical indicators. Drugs-related adverse events were recorded during treatment. All patients received TOAST analysis before leaving hospital. Results 1. In both groups, NIHSS was reduced after oneweek treatment, compared with that before treatment, while ADL was improved at three-month follow-up, compared with those at admission. The results showed statistically significant difference（P〈0.01） in each group, but no significant difference（P〉0.05） was found between two groups. The transient ischemic attacks（TIA） disappeared in both groups. Brain imaging showed that in three patients the lesion advanced to infarction in argatroban group（total 6 patients）, and two patients in the combined antiplatelet group（total 5 patients） suffered from the same change. 2. The brain imaging and measuring of r

关 键 词：卒中 阿加曲班 阿司匹林联合氯吡格雷 抗凝 血小板聚集抑制剂 

分 类 号：R743.31[医药卫生—神经病学与精神病学]