Chinese Journal of Stroke ›› 2023, Vol. 18 ›› Issue (12): 1391-1396.DOI: 10.3969/j.issn.1673-5765.2023.12.008

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Efficacy and Safety Study of Dual Antiplatelet Versus Alteplase in the Treatment of Acute Mild Non-Disabling Ischemic Stroke

LI Zhenhua1, ZHANG Jiangang1, XIE Weizheng1, WANG Yu2, LUO Xue1, LIU Conghui1, SUN Ke1, YANG Qingcheng1, GUO Yanping1   

  • Received:2022-02-18 Online:2023-12-20 Published:2023-12-20

双联抗血小板对比阿替普酶治疗急性轻型非致残性缺血性卒中的有效性和安全性研究

李振华1,张建刚1,谢卫征1,王禹2,罗雪1,刘聪慧1,孙科1,杨清成1,郭艳平1   

  1. 1  安阳 455000安阳市人民医院神经内科
    2  衢州市人民医院神经内科
  • 通讯作者: 杨清成 ay03728378@163.com 郭艳平 gyp9080@126.com
  • 基金资助:
    河南省医学科技攻关计划联合共建项目(LHGJ20191270)

Abstract: Objective  To compare the short-term clinical efficacy and safety of dual antiplatelet and alteplase intravenous thrombolysis in the treatment of acute mild non-disabling ischemic stroke.
Methods  Patients with mild non-disabling ischemic stroke (NIHSS score≤5, each item score≤1 and consciousness score 0) within 4.5 h of onset were randomly divided into thrombolysis group and dual antiplatelet group. Patients in thrombolysis group were treated with alteplase (0.9 mg/kg) intravenous thrombolysis, and patients in dual antiplatelet group were treated with aspirin enteric-coated tablets combined with clopidogrel hydrogen sulfate tablets. The NIHSS scores of the patients at 7 and 14 days after treatment were evaluated, and the early neurological deterioration and bleeding events within 14 days were recorded. 
Results  A total of 131 patients were enrolled in the group, including 67 patients in thrombolysis group and 64 patients in dual antiplatelet group. There was no significant difference in NIHSS score between dual antiplatelet group and thrombolysis group on the 7th day (P=0.677) and 14th day (P=0.842) after treatment. The incidence of bleeding events within 14 days in the dual antiplatelet group tended to be lower than that in the thrombolysis group, but the difference was not statistically significant (1.6% vs. 7.5%, P=0.106). The incidence of early neurological deterioration in the dual antiplatelet group was also lower than that in the thrombolysis group, and the difference was not statistically significant (6.3% vs. 13.4%, P=0.169). 
Conclusions  Ultra-early intravenous thrombolysis with alteplase does not bring significant short-term benefits compared with dual antiplatelet therapy in the treatment of mild non-disabling ischemic stroke, but it does not significantly increase the risk of bleeding. 

Key words: Antiplatelet; Alteplase; Mild stroke; Ischemic stroke; Non-disabling

摘要: 目的 对比双联抗血小板与阿替普酶静脉溶栓治疗急性轻型非致残性缺血性卒中的近期临床疗效和安全性。
方法 前瞻性连续入组发病时间4.5 h内的轻型非致残性缺血性卒中(NIHSS评分≤5分,各分项单项得分≤1分且意识项为0分)患者,随机分为溶栓组和双抗组。给予溶栓组患者阿替普酶(0.9 mg/kg)静脉溶栓治疗,给予双抗组患者阿司匹林肠溶片联合硫酸氢氯吡格雷片双抗治疗。评估患者治疗后7 d、14 d的NIHSS评分,并记录早期神经功能恶化、14 d内出现的出血事件。
结果 共入组131例符合纳入标准的患者,溶栓组67例,双抗组64例。双抗组和溶栓组治疗后7 d(P=0.677)、14 d(P=0.842)NIHSS评分差异均无统计学意义。双抗组14 d内出血事件的发生率有低于溶栓组的趋势,但差异未达统计学意义(1.6% vs. 7.5%,P=0.106),双抗组早期神经功能恶化的发生率也有低于溶栓组的趋势,差异也未达统计学意义(6.3% vs. 13.4%,P=0.169)。
结论 超早期阿替普酶静脉溶栓相较于双联抗血小板治疗轻型非致残性缺血性卒中并不能带来明显的短期获益,但也并不显著增加出血风险。

关键词: 抗血小板; 阿替普酶; 轻型卒中; 缺血性卒中; 非致残性