目的 探讨小剂量和标准剂量重组组织型纤溶酶原激活剂（rt-PA）静脉溶栓治疗高龄急性缺血性脑卒中（AIS）患者的安全性及有效性。 方法 前瞻性纳入自2019年2月至2023年2月于天津市中心医院卒中中心救治的201例高龄（≥ 80岁）AIS患者，随机分入小剂量组（n = 93，接受0.6 mg/kg剂量的rt-PA静脉溶栓治疗）和标准剂量组（n = 108，rt-PA剂量为0.9 mg/kg），比较两组患者间安全性评价指标（颅内出血发生率、症状性颅内出血发生率、致死性颅内出血发生率、7 d神经功能恶化率和90 d病死率）及有效性评价指标（7 d神经功能改善率和90 d预后良好率）的差异，并进行卒中严重程度和年龄的分层研究。 结果 小剂量组的颅内出血发生率、症状性颅内出血发生率和7 d致死性颅内出血发生率均低于标准剂量组（P < 0.05）；余安全性评价指标和治疗有效性评价指标，两组对比，差异均无统计学意义（P > 0.05）。在中型卒中和≥ 90岁年龄组中，小剂量组的90 d预后良好率均优于标准剂量组（P < 0.05）。 结论 对于中型卒中和年龄≥ 90岁的AIS患者，推荐rt-PA 0.6 mg/kg方案进行静脉溶栓治疗。

Objective To investigate the efficacy and safety of intravenous thrombolysis with low?dose and standard?dose recombinant tissue plasminogen activator （rt?PA） in the elderly patients （aged over 80 years） with acute ischemic stroke （AIS）. Methods A total of 201 elderly patients with AIS treated at Tianjin Fourth Central Hospital from February 2019 to February 2023 were prospectively included and randomly assigned to the rt?PA low?dose group （n = 93， 0.6 mg/kg） and rt?PA standard?dose group （n = 108， 0.9 mg/kg）. The incidence of intracranial hemorrhage， symptomatic intracranial hemorrhage， fatal intracranial hemorrhage， neurologic deterioration within 7 days and mortality within 90 days were observed to evaluate the safety. The neurologic improvement rate and good prognosis rate at 90 days were used to evaluate the effectiveness. A stratified analysis of 90?day outcomes was performed based on stroke severity and age. Results The incidence of intracranial hemorrhage， symptomatic intracranial hemorrhage and fatal intracranial hemorrhage within 7 days in rt?PA low?dose group was lower than that in rt?PA standard?dose group （P < 0.05）. There were no statistically significant differences between the two groups concerning the residual safety index and the effectiveness index. The 90?day good prognosis rate of moderate stroke sub?group and of ≥ 90 years of age sub?group in rt?PA low?dose group were both higher than that of rt?PA standard?dose group （P < 0.05）. Conclusions For AIS patients with moderate stroke and aged over 90 years， intravenous thrombolytic therapy with rt?PA 0.6 mg/kg is recommended.