非标准剂量阿替普酶静脉溶栓治疗急性缺血性卒中

目的比较分析非标准剂量与标准剂量阿替普酶静脉溶栓治疗急性缺血性卒中的有效性和安全性的差异。方法连续纳入北京大学深圳医院自2007年初-2015年底进行阿替普酶静脉溶栓治疗的急性缺血性卒中患者。根据阿替普酶使用剂量,分为非标准剂量组(0.521~0.833 mg/kg)和标准剂量组(0.9 mg/kg),比较分析两剂量组溶栓24 h后颅内出血率、死亡率及90 d mRS评分情况。结果溶栓前mRS评分均为0分,其中非标准剂量组48例(0.521~0.833 mg/kg,中位数为0.7245 mg/kg);标准剂量组51例(0.9 mg/kg)。两剂量组溶栓前NIHSS评分中位数均为13分,发病到溶栓时间的均值分别为200.75 min和197.53 min。校正基线变量差异后,两组症状性颅内出血率(8.33%vs 5.88%,P=0.727),死亡率(6.25%vs 9.8%,P=0.796),90 d患者生活自理比例(64.58%vs 64.71%,P=0.641)及获得良好预后比例(56.25%vs 49.02%,P=0.645)之间的差异均无统计学意义。结论非标准剂量阿替普酶静脉溶栓具有与标准剂量相同的有效性及安全性。对于中国人群,阿替普酶最佳剂量可能处于0.6~0.9 mg/kg之间。

Non standard-dose intravenous alteplase in acute ischemic stroke

Objective To compare the efficacy and safety of non standard-dose and standard-dose intravenous alteplase in Chinese patients with acute ischemic stroke.Methods Eligible patients from Peking University Shenzhen Hospital were consecutively enrolled into the study from 2007 to 2015.According to the dose of alteplase received for managing acute ischemic stroke,they were divided into 2 groups:the non standard-dose (0.521～0.833 mg/kg) and the standard-dose (0.9 mg/kg).We analyzed symptomatic intracranial hemorrhage (SICH),mortality and 90 day outcome of these patients.Results Modified Rankin Scale before thrombolysis were 0.Among them,48 had 0.521～0.833 mg/kg,median alteplase doses were 0.7245 mg/kg,as an non standard-dose group,and 51 had 0.9 mg/kg as a standard-dose group.Median NIHSS score before thrombolysis were both 13.Median time from stroke onset to needle were 200.75 min and 197.53 min,respectively.After adjustment for the baseline variables,no significant differences were found between the 2 groups in symptomatic intracranial hemorrhage (8.33% vs 5.88%,P=0.727),mortality(6.25% vs 9.8%,P=0.796),mRS score 0～2 (64.58% vs 64.71%,P=0.641)or mRS score 0～1 (56.25% vs 49.02%,P=0.645).Conclusion The efficiency and safety of non standard-dose intravenous alteplase are same with the standard-dose for acute ischemic stroke.And the optimum dose may be another one between 0.6 mg/kg to 0.9 mg/kg for Chinese patients.