重组组织型纤溶酶原激活剂早期静脉溶栓对急性脑梗死的疗效  

Clinical study on early intravenous thrombolysis with rt-PA for acute cerebral infarction

作　　者：王雪里红 曾红[1] 樊琨[1] 王克英[1] 左鹰[1] 王沈燕[1] 胡南[1] 李学英[1] 赵永春[1] 王洪源[2] 

机构地区：[1]北京急救中心急诊科,100031 [2]北京大学公共卫生学院统计教研室

出　　处：《中华神经科杂志》2006年第10期678-683,共6页Chinese Journal of Neurology

基　　金：北京市科学技术委员会科研基金资助项目(H010210270113)

摘　　要：目的评价重组组织型纤溶酶原激活剂(rt-PA)6h内静脉溶栓治疗急性脑梗死的疗效及剂量。方法将符合入选标准的206例患者随机分为A、B、C组,A组rt-PA0.9mg/kg,B组rt-PA0.7mg/kg,C组为对照组,不用rt-PA;每组又各分为两个亚组,低分子肝素组(A1、B1、C1)和非低分子肝素组(A2、B2、C2)。采用“中国脑卒中临床神经功能缺损评分标准”(CSS)及Barthel指数(BI)评定溶前及溶后24h、3d、7d、90d的疗效。结果90d各组的有效率:A组79.80%,B组86.55%,C组63.70%;90d显效率:A组68.75%,B组74.85%,C组42.05%;90d痊愈率:A组46.05%,B组39.45%,C组21.10%;90d病死率:A组11.76%,B组10.39%,C组18.03%;以上各项A+B组与C组差异有统计学意义,A与B组差异无统计学意义,而低分子肝素组与非低分子肝素组差异无统计学意义。各组总出血发生率:A组20.59%,B组18.18%,C组0;各组48h内脑出血率:A组8.82%,B组6.49%,C组0;14d脑出血率:A组10.29%,B组7.79%,C组0;各项A+B组与C组差异有统计学意义,A与B组差异无统计学意义。症状性脑出血率:A组1.47%,B组2.60%,C组0,A+B组与C组差异无统计学意义,低分子肝素组与非低分子肝素组差异无统计学意义。90d重度致残率+病死率:A组23.52%、B组22.08%、C组32.79%,A+B组与C组差异有统计学意义。结论rt-PA6h内静脉溶栓治疗急性脑梗死90d有效率、显效率、痊愈率较对照组显著提高。rt-PA6h内静脉溶栓治疗急性脑梗死是安全有效的。溶栓剂量0.7mg/kg与0.9mg/kg疗效基本相同,对于部分高龄体弱的中国人,0.7mg/kg可能更为安全经济。Objective To evaluate the efficacy and the safety of different doses of Actilyse （recombinant tissue plasminogen activator） in early treatment of the Chinese patients with acute cerebral infarction. Methods This project started from April 2001 and ended in June 2004. Patients were chosen who met the criteria aged between 35-75, within 6 hours of onset of cerebral infarct, with hemiplegia between level 0-3, with normal consciousness or lethargy, with blood pressure below 180/110 mm Hg and with computed tomography （CT） scan suggesting neither hemorrhage nor infarction. 206 patients were randomly divided into 3 groups, group A, B and C matched in age and sex. Group A and B received the treatment with different doses of Actilyse 0.9 mg/kg and 0.7 mg/kg intravenously over 60 min and group C was as controls receiving no thrombolytic therapy. Three groups were further subdivided into two groups which were group A1 and A2, group B1 and B2, group C1 and C2. The patients in groups A1, B2, C1 received Clexane （ low-molecular-weight heparin） 0.4 ml subcutaneously b. i. d, and aspirin 0.1 mg qd after 24 hours receiving Actilyse while group A2, B2, C2 received neither Clexane nor aspirin. The Chinese Stroke Scale （CSS） and Barthel Index （BI） were used to evaluate the neurological functions before and 24 hours, 3 days, 7 days, and 90 days after receiving rt-PA. The authors performed both methods of Logistic regression analysis and Fisher＇ exact test in statistic. Results The effective rate, significant effective rate, and curative rate in 90 days in group A and group B were significantly higher than in group C （ P 〈 0. 01 ）. The effective rate was 79.80% in group A, 86. 55% in group B and 63.70% in group C, respectively; the significantly effective rate was 68.75% in group A, 74. 85% in group B and 42. 05% in group C, respectively; the curative rate was 46.05% in group A, 39.45% in group B, and 21.10% in group C, respectively. There was no significant difference between group A and B. The mortality r

关 键 词：组织型纤溶酶原激活物 血栓 溶解疗法 脑梗塞 

分 类 号：R743.3[医药卫生—神经病学与精神病学]