Abstract: Objective FDA recomanded 0.9mg/kg IV rt-PA in thrombolysis treatment for acute ischemic stroke.The trials about IV rt-PA in china have chosen some different dose. To analyze the suitable dosage of rt-PA in Chinese we compared 0.9mg/kg IV rt-PA with 0.6-0.8mg/kg(50mg/person) IV rt-PA.Methods 30 patients were randomly assigned in our study. The NIHSS were from 2 to 26, the stroke onset time is 0.5 to 6 hours, without contraindications to thrombolytic therapy(China cerebrovasculardisease guide contraindication of thrombolysis). The patients were randomly divided into Group A and B, Group A with rt-PA 50mg/person, Group B with rt-PA 0.9mg/kg. To compare between two groups the number of patients with a decrease of 4 or more points on the National Institutes of HealthStroke Scale (NIHSS) at 24 hours and day 14. The intracerebral hemorrhage rate and mortality were also be compared.Results The two groups were well matched on baseline characteristics, including NIHSS (mean of 10.17for both). NIHSS improvement rate of group B at day 14 is signifcient better than group A (86.67% vs 53.3%, P <0.05).The intracerebral hemorrhage rate of two groups were both 6%. Themortality at 14 days in Group A were higher than Group B(26.67% vs 20%, P =0.67).Conclusion This study found significant benefit on 14 days in patients treated by 0.9mg/kg IV rt-PA than (0.6-0.8)mg/kg(50mg/person) IV rt-PA after stroke onset. Risk of intracerebral hemorrhage and mortality was not increased in 0.9mg/kg IV rt-PA. 0.9mg/kg IV rt-PA was suitable for Chinese inthrombolysis treatment for acute ischemic stroke.

Key words: Tissue plasminogen activator; Dose-response relationship; drug; Treatment outcome; Intracerebral hemorrhages; Mortality

摘要： 目的 重组组织型纤溶酶原激活剂（reconstructive tissue plasminogen activator，rt-PA）在静脉溶栓治疗急性缺血性卒中时，美国食品药品管理局（food and drug administration，FDA）批准剂量为0.9mg/kg（总量≤90mg），国内亦有应用剂量0.6～0.8mg/kg（总量50mg）。本试验拟探讨两种剂量rt-PA的疗效及安全性。方法 纳入急性缺血性卒中患者30例，美国国立卫生研究院卒中量表（N ati o n a l I n sti tu te s of Health Stroke Scale NIHSS）评分2～26分，发病时间0.5～6h，无溶栓禁忌证。随机分为两组：rt-PA0.6～0.8mg/kg（总量50mg）组（A组）和0.9mg/kg组（B组）。比较两组治疗前、治疗后24h及14d的NIHSS评分改善率（≥4分）及颅内出血率、死亡率。结果 两组治疗前的基本资料无统计学差异，NIHSS评分平均为10.17分。B组治疗后14d NIHSS评分改善率明显优于A组（86.67% vs 53.3%，P <0.05）。两组发生颅内出血的比例均为6%。两组死亡病例均为非出血性病变，A组死亡率略高于B组，但无统计学差异（26.67% vs 20%，P =0.67）。结论 rt-PA 0.9mg/kg剂量疗效优于0.6～0.8mg/kg剂量，并未增加颅内出血并发症及死亡率，该溶栓剂量同样适用于国人。

关键词: 组织型纤溶酶原激活物; 剂量效应关系; 药物; 治疗结果; 颅内出血; 死亡率