低剂量阿替普酶治疗轻型缺血性脑卒中的疗效及安全性分析
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乐山市人民医院神经内科, 四川 乐山 614000

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谢孟桥(1989―),女,主治医师,硕士研究生,研究方向:脑小血管病及认知障碍。Email:563507454@qq.com。

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Efficacy and safety of low-dose alteplase in treatment of patients with minor ischemic stroke
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Department of Neurology, People’s Hospital of Leshan, Leshan, Sichuan 614000, China

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    摘要:

    目的 探讨低剂量阿替普酶治疗轻型缺血性脑卒中患者的有效性和安全性。方法 回顾性收集2017年11月至2022年1月于发病4.5 h内就诊于乐山市人民医院的轻型缺血性脑卒中[美国国立卫生研究院卒中量表(NIHSS)评分≤5分]患者143例,根据患者接受治疗的方式分为低剂量组(49例)、标准剂量组(46例)和对照组(48例)。低剂量组患者发病4.5 h内接受阿替普酶(0.6 mg/kg)静脉溶栓,24 h后若无出血转化,则采用双抗治疗21 d;标准剂量组于4.5 h内接受阿替普酶(0.9 mg/kg)静脉溶栓,后续抗栓方案同低剂量组;对照组入院即刻接受双抗治疗21 d。比较3组患者24 h及7 d的NIHSS评分与基线水平的差异;对比3组患者24 h的NIHSS评分、7 d的NIHSS评分以及90 d良好功能结局、轻度残疾、中重度残疾所占比例的差异;比较3组患者36 h内出血事件发生率、7 d及90 d死亡率的情况。结果 低剂量组与标准剂量组治疗后24 h的NIHSS评分、3组患者7 d的NIHSS评分均较基线水平降低,差异具有统计学意义(P<0.05)。3组患者间24 h的NIHSS评分差异无统计学意义(P>0.05)。低剂量组和标准剂量组7 d的NIHSS评分低于对照组,差异有统计学意义(P<0.05);低剂量组和标准剂量组7 d的NIHSS评分比较差异无统计学意义(P>0.05)。3组患者90 d良好功能结局、轻度残疾、中重度残疾比例差异均无统计学意义(P>0.05)。安全性方面,低剂量组与标准剂量组、低剂量与对照组各类型出血发生率差异均无统计学意义(P>0.05);标准剂量组口腔及皮肤黏膜出血发生率高于对照组,差异有统计学意义(P<0.05);2组间其他类型出血发生率差异无统计学意义(P>0.05)。3组患者7 d、90 d死亡率差异无统计学意义(P>0.05)。结论 低剂量阿替普酶可能加快轻型缺血性脑卒中患者症状恢复,与标准剂量阿替普酶疗效相似,且不显著增加出血及死亡风险。 [国际神经病学神经外科学杂志, 2022, 49(6): 7-12]

    Abstract:

    Objective To investigate the efficacy and safety of low-dose alteplase in the treatment of patients with minor ischemic stroke.Methods A retrospective analysis was performed for the clinical data of 143 patients with minor ischemic stroke [National Institutes of Health Stroke Scale (NIHSS) score ≤5] who were admitted to The People’s Hospital of Leshan within 4.5 hours after onset from November 2017 to January 2022, and according to the treatment method, they were divided into low-dose group with 49 patients, standard-dose group with 46 patients, and control group with 48 patients. The patients in the low-dose group received intravenous thrombolysis with alteplase (0.6 mg/kg) within 4.5 hours after onset, and if there was no hemorrhagic transformation after 24 hours, they were given dual anti-platelet therapy for 21 days; the patients in the standard-dose group received intravenous thrombolysis with alteplase (0.9 mg/kg) within 4.5 hours, followed by the same antithrombotic regimen as the low-dose group; the patients in the control group received dual anti-platelet therapy for 21 days immediately after admission. The three groups were compared in terms of the following indicators: the change in NIHSS score at 24 hours and on day 7 compared with the baseline level; NIHSS score at 24 hours and on day 7 and the proportion of patients with good functional outcome, mild disability, and moderate-to-severe disability on day 90; the incidence rate of bleeding events with 36 hours and 7- and 90-day mortality rates.Results The low-dose group and the standard-dose group had a significant reduction in NIHSS score at 24 hours after treatment, and all three groups had a significant reduction in NIHSS score on day 7 compared with the baseline level (P<0.05). There was no significant difference in NIHSS score at 24 hours between the three groups (P>0.05). The low-dose group and the standard-dose group had a significantly lower NIHSS score on day 7 than the control group (P<0.05), while there was no significant difference between the low-dose group and the standard-dose group (P>0.05). There was no significant difference between the three groups in the proportion of patients with good functional outcome, mild disability, or moderate-to-severe disability on day 90 (P>0.05). As for safety, there were no significant differences in the incidence rates of various types of bleeding between the low-dose group and the standard-dose group and between the low-dose group and the control group (P>0.05); the standard-dose group had significantly higher incidence rates of oral hemorrhage and mucocutaneous hemorrhage than the control group (P<0.05), while there were no significant differences in the incidence rates of other types of bleeding between the two groups (P>0.05). There were no significant differences in 7- and 90-day mortality rates between the three groups (P>0.05).Conclusions Low-dose alteplase may accelerate the recovery of neurological symptoms in patients with mild stroke and has similar efficacy to standard-dose alteplase, without significantly increasing the risk of bleeding and death. [Journal of International Neurology and Neurosurgery, 2022, 49(6): 7-12]

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谢孟桥,黄惠英,佐小丽,胡佳,蒋奇慧,张珊456.低剂量阿替普酶治疗轻型缺血性脑卒中的疗效及安全性分析[J].国际神经病学神经外科学杂志,2022,49(6):7-12111XIE Meng-Qiao, HUANG Hui-Ying, ZUO Xiao-Li, HU Jia, JIANG Qi-Hui, ZHANG Shan222. Efficacy and safety of low-dose alteplase in treatment of patients with minor ischemic stroke[J]. Journal of International Neurology and Neurosurgery,2022,49(6):7-12

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  • 收稿日期:2022-06-19
  • 最后修改日期:2022-11-28
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  • 在线发布日期: 2023-02-01
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