小剂量重组组织型纤溶酶原激活剂在中国急性缺血性卒中患者中的安全性和有效性  

Safety and efficacy of low-dose recombinant tissue plasminogen activator in Chinese patients with acute ischemic stroke

作　　者：田月明[1] 佟旭[2] 曹亦宾[1] 刘静华[1] 史楠[1] 

机构地区：[1]河北医科大学附属唐山工人医院神经内科,唐山063000 [2]首都医科大学附属北京天坛医院神经内科,北京100050

出　　处：《国际脑血管病杂志》2015年第8期588-592,共5页International Journal of Cerebrovascular Diseases

摘　　要：目的探讨小剂量重组组织型纤溶酶原激活剂（recombinant tissue plasminogen activator, rtPA）静脉溶栓治疗中国急性缺血性卒中患者的安全性和有效性。方法回顾性纳入在发病4．5h内接受rtPA静脉溶栓的连续急性缺血性卒中患者。根据rtPA剂量分为小剂量组（0．5—0．8mg／kg，最大剂量50mg）和标准剂量组（0．9mg／kg，最大剂量90mg）。比较2组有症状颅内出血（ symptomatic intracranial hemorrhage, sICH）[分别采用美国国立神经疾病与卒中研究所（ National Institute of Neurological Disorders and Stroke, NINDS ）、欧洲急性卒中协作研究Ⅱ（European Cooperative Acute Stroke StudyⅡ，ECASS Ⅱ）以及欧洲卒中溶栓安全监测研究（Safe Implementation of Thrombolysis in Stroke-Monitoring Study，SITS—MOST）的3种定义]、90d死亡、90d转归良好[改良Rankin量表（modified Rankin Scale，mRS）评分0～1分]和生活自理（mRS评分0～2分）的发生率。结果共纳入163例患者，小剂量组74例，标准剂量组89例。小剂量组高血压（44．6％对68．5％；χ……2=9．490，P=0．002）和糖尿病（5．4％对28．1％;χ^2=14.216，P〈0．001）的患者构成比显著低于标准剂量组，而吸烟（56．8％对38．2％；χ^2=5．590，P=0．018）和小动脉闭塞性卒中（21．6％对10．1％；χ^2=4．122，P=0．042）的患者构成比显著高于标准剂量组。在校正年龄、美国国立卫生研究院卒中量表（National Institutes of Health Stroke Scale，NIHSS）评分、高血压、糖尿病、吸烟和缺血性卒中分型后，多变量二分类logistic分析显示，2组之间NINDS定义的sICH[10．8％对9．0％；优势比（odds ratio，OR）1．077，95％可信区间（confidence interval,CI）0．338～3．436]、ECASSⅡ定义的sICH（9．5％对9．0％；OR0．976，95％CI0．296～3．221）、SITS—MOST定义的sICH（8．1％对4．5％；OR2．269，95％CI0．522～9．852）、90d死亡（17．6�Objective To investigate the safety and efficacy of low-dose recombinant tissue plasminogen activator （rtPA） in Chinese patients with acute ischemic stroke. Methods Consecutive patients with acute ischemic stroke received rtPA intravenous thrombolysis within 4. 5 h after symptom onset were enrolled retrospectively. According to the dosage of rtPA, they were divided into either a low-dose group （0. 5 - 0. 8 mg/kg, the maximum dose 50 mg） or a standard dose group （0. 9 mg/kg, the maximum dose 90 mg）. The incidences of symptomatic intracranial hemorrhage （slCH） （the National Institute of Neurological Disorders and Stroke [ NINDS ], and European Cooperative Acute Stroke Study Ⅱ [ ECASS Ⅱ], European Safe Implementation of Thrombolysis in Stroke-Monitoring Study [ SITS-MOST ]）, 90 d mortality, 90 d good outcome （the modified Rankin Scale [ mRS ] score 0 - 1 ）, and life self-care ability （mRS score 0 -2） were compared between the two groups. Results A total of 163 patients were enrolled, including 74 patients in the low-dose group and 89 in the standard dose group. The constituent ratios of hypertension （44. 6% vs. 68.5% ; χ^2 = 9. 490, P = 0. 002） and diabetes （5.4% vs. 28.1% ; χ^2 = 14. 216, P 〈0. 001） in the patients of the low-dose group were significantly lower than those of the standard group, while the constituent ratios of smoking （56. 8% vs. 38.2% ; χ^2 = 5. 590, P = 0. 018） and small artery occlusive stroke （21.6% vs. 10. 1%; χ^2 = 4. 122, P= 0. 042） in patients of the low-dose group were significantly higher than those of the standard group. After adjusting for age, National Institutes of Health Stroke Scale （NIHSS） score, hypertension, diabetes, smoking, and ischemic stroke typing, multivariate binary logistic analysis showed that there were no significant differences in NINDS defined slCH （10. 8% vs. 9. 0%, odds ratio [ OR] 1. 077, 95% confidence interval [ CI]0. 338 - 3. 436）, ECASS Ⅱ defined slCH （9. 5% vs. 9. 0% ; OR 0. 976, 95% CI 0. 296

关 键 词：卒中 脑缺血 血栓溶解疗法 组织型纤溶酶原激活物 输注 静脉内 治疗结果 剂量 效应关系 药物 

分 类 号：R743.3[医药卫生—神经病学与精神病学]