Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
China National Clinical Research Center for Neurological Diseases, Beijing, China.
CNS Neurosci Ther. 2023 Aug;29(8):2308-2317. doi: 10.1111/cns.14164. Epub 2023 Mar 21.
Our study aimed to describe the short-, medium-, and long-term outcomes of intravenous thrombolysis in minor stroke, and to explore the relationship between thrombolysis and clinical outcomes.
Our study included ischemic minor stroke patients (National Institutes of Health Stroke Scale score ≤ 5) within 4.5 h from symptom onset from the Third China National Stroke Registry (CNSR-III) between August 2015 and March 2018. The primary outcome was a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0-1 at 3 months. The secondary outcomes included mRS score of 0-1 at discharge, 6 months, and 1 year. The safety outcomes were symptomatic intracerebral hemorrhage (sICH) at 24-36 h and all-cause mortality. The association between intravenous thrombolysis and clinical outcomes was studied using multivariable models.
A total of 1905 minor ischemic stroke patients were included. Overall 527 patients (28%) received intravenous t-PA (IV t-PA) and 1378 patients (72%) in the non-IV t-PA group. Of them, 18.85% (359/1905) participants had a disabled outcome (defined as mRS score ≥ 2) at discharge, 12.8% (242/1885) at 3 months, 13.9% (262/1886) at 6 months, and 13.9% (260/1871) at 1 year. In multivariable analysis, IV t-PA was associated with favorable functional outcomes at discharge (adjusted odds ratio [aOR] 1.49; 95% confidence interval [CI] 1.13-1.96; p = 0.004), 3 months (aOR 1.51; 95% CI 1.09-2.10; p = 0.01), 6 months (aOR 1.64; 95% CI 1.19-2.27; p = 0.003), and 1 year (aOR 1.52; 95% CI 1.10-2.10; p = 0.01). Symptomatic ICH occurred in 3 (0.6%) patients in IV t-PA versus 2 (0.1%) in the non-IV t-PA group. No significant differences were found in all-cause mortality between the two groups.
Intravenous t-PA may be safe and effective in minor stroke (NIHSS ≤ 5) within a 4.5-h window and further randomized controlled trials are warranted.
本研究旨在描述小卒中患者静脉溶栓的短期、中期和长期结局,并探讨溶栓与临床结局的关系。
本研究纳入了 2015 年 8 月至 2018 年 3 月期间第三次中国国家卒中登记研究(CNSR-III)中发病 4.5 小时内的小卒中(美国国立卫生研究院卒中量表评分≤5)患者。主要结局为 3 个月时的良好功能结局,定义为改良 Rankin 量表(mRS)评分 0-1 分。次要结局包括出院时、6 个月和 1 年的 mRS 评分 0-1 分。安全性结局为溶栓后 24-36 小时出现症状性颅内出血(sICH)和全因死亡率。采用多变量模型研究静脉溶栓与临床结局的关系。
共纳入 1905 例小缺血性卒中患者。总体上,527 例(28%)患者接受了静脉 t-PA(IV t-PA)治疗,1378 例(72%)患者接受了非 IV t-PA 治疗。其中,18.85%(359/1905)的患者出院时存在残疾结局(定义为 mRS 评分≥2 分),12.8%(242/1885)的患者在 3 个月时、13.9%(262/1886)的患者在 6 个月时、13.9%(260/1871)的患者在 1 年时存在残疾结局。多变量分析显示,IV t-PA 与出院时的良好功能结局(调整优势比 [aOR] 1.49;95%置信区间 [CI] 1.13-1.96;p=0.004)、3 个月时(aOR 1.51;95% CI 1.09-2.10;p=0.01)、6 个月时(aOR 1.64;95% CI 1.19-2.27;p=0.003)和 1 年时(aOR 1.52;95% CI 1.10-2.10;p=0.01)相关。IV t-PA 组发生症状性 ICH 的有 3 例(0.6%),而非 IV t-PA 组有 2 例(0.1%)。两组的全因死亡率无显著差异。
在 4.5 小时的时间窗内,静脉 t-PA 治疗小卒中(NIHSS≤5)可能是安全有效的,需要进一步的随机对照试验。