中国卒中杂志 ›› 2022, Vol. 17 ›› Issue (12): 1321-1326.DOI: 10.3969/j.issn.1673-5765.2022.12.007

• 论著 • 上一篇    下一篇

县级医院急性缺血性卒中超时间窗经MRI筛选溶栓的病例对照研究

鲁燕, 杨保荣, 黄向萍, 杨冠桂, 陈圣文, 李建荣, 曾小明   

  1. 1 赣州 342400 江西省赣州市兴国县人民医院卒中中心,神经内科  

    2 江西省赣州市兴国县人民医院卒中中心,神经外科 

    3 江西省赣州市兴国县人民医院放射科 

    4 江西省赣州市兴国县人民医院急诊科

  • 收稿日期:2022-07-28 出版日期:2022-12-20 发布日期:2022-12-20
  • 通讯作者: 曾小明 328739761@qq.com

MRI-Guided Thrombolysis beyond Time Window in Acute Ischemic Stroke in a County-Level Hospital: A Case-Control Study

  • Received:2022-07-28 Online:2022-12-20 Published:2022-12-20

摘要: 目的 探索在中国县级医院条件下,急性缺血性卒中患者经急诊MRI筛选后进行超时间窗溶栓的安全性和有效性以及在中国基层卒中中心进行影像学指导超时间窗溶栓的可行性。
方法 前瞻性连续纳入2021年7月-2022年1月江西省兴国县人民医院经头颅MRI筛选后符合影像错配(DWI序列高信号-FLAIR序列等信号)标准并进行超时间窗静脉溶栓的首次急性缺血性卒中患者为超时间窗溶栓组。以同时间段标准溶栓时间窗内(发病4.5 h内)静脉溶栓的急性缺血性卒中患者为对照组(标准时间窗溶栓组)。主要有效性结局为3个月时功能结局良好(mRS 0~1分)。主要安全性结局为36 h内症状性出血转化(NIHSS较基线增加≥4分且影像学证实颅内出血)。比较两组溶栓治疗的有效性和安全性,同时对两组的过程结局(基线、溶栓24 h和出院时NIHSS)进行组内比较。
结果 研究共纳入超时间窗溶栓组39例,其中男性23例,女性16例,平均年龄为69.6±10.4岁;标准时间窗溶栓组60例,其中男性39例,女性21例,平均年龄66.1±11.0岁。在有效性结局方面,两组发病3个月功能结局良好率差异无统计学意义(超时间窗溶栓组64.1% vs. 标准时间窗溶栓组76.7%,P=0.175)。在安全性结局方面,两组的症状性出血转化率差异无统计学意义(超时间窗溶栓组0 vs. 标准时间窗溶栓组1.7%,P=0.418)。在过程结局方面,超时间窗溶栓组溶栓24 h[3.0(2.0~5.0)分]和出院时NIHSS[1.0(0~5.0)分]较基线NIHSS[4.0(3.0~8.5)分]均改善,差异有统计学意义;标准时间窗溶栓组出院时NIHSS[0(0~2.0)分]较基线NIHSS[4.0(2.0~8.3)分]改善,差异有统计学意义。
结论 在中国县级医院对超时间窗缺血性卒中患者进行MRI筛选下的标准剂量阿替普酶静脉溶栓治疗是可行且安全的,有进一步在国内基层卒中中心推广的价值。

文章导读: 本研究基于中国县级医院医师资源和设备配置,探索了相对快速、便捷的检查和筛查标准,证明在基层 医院对超时间窗或发病时间不明确的缺血性卒中患者进行静脉阿替普酶溶栓治疗的安全性、有效性和可行性。

关键词: 卒中; 醒后卒中; 超时间窗; 静脉溶栓; 磁共振成像

Abstract: Objective  To explore the safety and efficacy of MRI-guided thrombolysis beyond time window in patients with acute ischemic stroke in a county-level hospital in China.
Methods  The consecutive patients with first acute ischemic stroke who underwent intravenous thrombolysis guided by MRI (mismatch of high signal on DWI-equal signal on FLAIR) in Xingguo People’s Hospital, Jiangxi Province from July 2021 to January 2022 were enrolled in this prospective study. The patients who underwent intravenous thrombolysis beyond time window (>4.5 hours) were selected as the observation group, and the patients who underwent intravenous thrombolysis within 4.5 hours of onset were selected as the control group. The primary efficacy outcome was a good functional outcome (defined as a mRS score of 0 to 1) at 3 months. The primary safety outcome was symptomatic hemorrhagic transformation within 36 hours (defined as an increase of 4 score in NIHSS from baseline and MRI-based intracranial hemorrhage). The efficacy and safety of thrombolysis were compared between the two groups. The NIHSS scores at different time points (baseline, at 24 hours after thrombolysis and at discharge) were compared in each group.
Results  A total of 39 cases were included in the observation group, with a mean age of 69.6±10.4 years and 23 males; and 60 cases in the control group, with a mean age of 66.1±11.0 years and 39 males. There was no statistical difference in the percentage of 90-day good functional outcome between the two groups (observation vs. control: 64.1% vs. 76.7%, P=0.175); and there was also no statistical difference in the percentage of symptomatic hemorrhagic transformation between the two groups (observation vs. control: 0 vs. 1.7%, P=0.418). The NIHSS scores at 24 hours [3.0 (2.0-5.0)] and at discharge [1.0 (0-5.0)] improved compared to the baseline NIHSS [4.0 (3.0-8.5)] in the observation group, and the NIHSS score at discharge [0 (0-2.0)] improved compared to the baseline NIHSS [4.0 (2.0-8.3)] in the control group, with all the above differences having statistical significance.
Conclusions  The MRI-guided intravenous thrombolysis beyond time window in patients with ischemic stroke is feasible and safe in county-level hospitals in China.

Key words: Stroke; Wake-up stroke; Beyond time window; Intravenous thrombolysis; Magnetic resonance imaging