急性缺血性脑卒中阿替普酶给药期间不良事件分析

doi:10.19803/j.1672-8629.20260561

摘要/Abstract

摘要： 目的分析急性缺血性脑卒中（Acute Ischemic Stroke,AIS）患者阿替普酶（Recombinant Tissue Plasminogen Activator,rt-PA）给药期间药品不良事件（Adverse Drug Event,ADE）,为溶栓期间安全用药监测提供参考。方法回顾性纳入2016年1月1日至2025年12月31日南京鼓楼医院接受rt-PA静脉溶栓的1 126例AIS患者,根据给药期间是否发生ADE分为ADE组和non-ADE组。描述ADE类型、严重程度及临床处置,比较两组基线资料和实际给药剂量,并采用单因素及多因素Logistic回归分析ADE相关影响因素。结果共纳入1 012例患者,其中373例（36.9%）在rt-PA给药期间发生ADE,以轻中度非颅内出血为主,未观察到ADE相关死亡。ADE患者中,206例（55.2%）中断rt-PA给药。ADE组实际给药剂量低于non-ADE组（P<0.001）。多因素Logistic回归分析显示,女性（OR=1.383 5,95%CI：1.052 3~1.818 8）、既往使用降脂药（OR=1.969 4,95%CI：1.248 0~3.107 6）、既往使用降压药（OR=1.382 0,95%CI：1.057 8~1.805 7）及D-二聚体水平升高（OR=1.076 1,95%CI：1.016 4~1.139 3）与ADE发生风险增加相关,而血小板计数升高与ADE发生风险降低相关（OR=0.997 5,95%CI：0.995 5~0.999 6）（均P<0.05）。结论 AIS患者rt-PA给药期间ADE可影响给药完整性和实际给药剂量,其发生与性别、既往用药及凝血指标有关。临床应加强给药期间监测,并根据ADE的类型及严重程度合理处置,以提高用药安全性。

关键词: 急性缺血性脑卒中, 阿替普酶, 静脉溶栓, 给药剂量, 药品不良事件

Abstract: Objective To characterize adverse drug events (ADE) during administration of recombinant tissue plasminogen activator (rt-PA) in patients with acute ischemic stroke (AIS) and evaluate the actual rt-PA dose administered in order to contribute to safe medication during thrombolysis. Methods Patients with AIS who received intravenous thrombolysis with rt-PA in 2016-2025 were retrospectively identified and included. Patients were divided into the ADE and non-ADE groups according to the occurrence of ADE during rt-PA administration. The type, severity, and clinical management methods of ADE were described. Baseline characteristics and actual rt-PA doses administered were compared between the two groups. Univariable and multivariable logistic regression analyses were performed to identify contributors to ADE. Results A total of 1 012 patients were included, 373 (36.9%) of whom experienced ADE during rt-PA administration that were mostly mild or moderate non-intracranial bleeding events, but no deaths attributable to ADE were observed. Among these 373 patients, rt-PA administration was discontinued in 206 (55.2%). The actual rt-PA dose administered was significantly lower in the ADE group than in the non-ADE group (P<0.001). Multivariable logistic regression analysis showed that being female (OR=1.383 5, 95%CI: 1.052 3-1.818 8), prior lipid-lowering medications (OR=1.969 4, 95%CI: 1.248 0-3.107 6), prior antihypertensive medications (OR=1.382 0, 95%CI: 1.057 8-1.805 7), and higher D-dimer levels (OR=1.076 1, 95%CI: 1.016 4-1.139 3) could increase the odds of ADE (all P<0.05) while higher platelet counts were associated with lower chance of ADE (OR=0.997 5, 95%CI: 0.995 5-0.999 6; P<0.05). Conclusion ADE during rt-PA administration in patients with AIS might impact the completion of rt-PA administration and the actual dose administered. The incidence is associated with gender, prior medications, and hemostasis-related laboratory parameters. Monitoring during rt-PA administration and appropriate management according to the types and severity of ADE are warranted to ensure safe medication.

Key words: Acute Ischemic Stroke(AIS), Alteplase, Intravenous Thrombolysis, Administered Dose, Adverse Drug Event

中图分类号:

张嘉麟, 胡佳, 徐吟秋, 蒋陈晓, 李俐. 急性缺血性脑卒中阿替普酶给药期间不良事件分析[J]. 中国药物警戒, 2026, 23(10): 1164-1170.

Zhang Jialin, Hu Jia, Xu Yinqiu, Jiang Chenxiao, Li Li. Adverse events during administration of alteplase for acute ischemic stroke[J]. Chinese Journal of Pharmacovigilance, 2026, 23(10): 1164-1170.

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