国家神经系统疾病临床医学研究中心数据管理与共享系统

发表杂志： CNS Neuroscience & Therapeutics

发表类型: Original Contributions

影响因子(IF): 5.5

PMID: 36942504 Pubmed原文链接 全文下载

脑卒中约有一半首次表现为轻型卒中（NIHSS≤5）[1]，只有约13.5%轻型卒中接受静脉溶栓治疗[2]。临床实践中拒绝静脉溶栓原因除了超时间窗外，很大一部分原因是由于轻型卒中，认为病情太轻而不需要或可自行缓解或担心出血风险未及时溶栓[3]。 目前关于急性轻型卒中溶栓证据有限，因为大部分有关溶栓治疗的随机对照试验 （randomized controlled trial, RCT）都将轻型卒中排除[4-7]。PRISMS研究[8]是目前公开发表的一项针对非致残性轻型卒中的III期RCT研究，该研究未能证实阿替普酶静脉溶栓优于阿司匹林治疗，但该试验由于资金问题只纳入313例患者提前中止，并不能得出确证性结论。2014年一项基于9大RCT研究的meta分析提示轻型卒中（NIHSS≤4）使用阿替普酶相较于对照组可获得良好结局比例[9], 基于此结果，2019年美国急性缺血性卒中早期管理指南更新版对于发病3小时内的致残性轻型卒中给予rt-PA静脉溶栓治疗I类推荐[10]。但由于对致残性卒中定义带有主观因素，临床实践和研究中操作不统一。MaRISS研究基于美国跟着指南走注册登记得出急性轻型卒中无论溶栓还是不溶栓，随访90天时，37%患者为致残性卒中，25%不能独立生活[11]。故目前对于急性轻型卒中溶栓与否仍存在争议，且缺乏来自亚洲人群数据。 我们的研究假设是临床和影像学上的指标有助于识别4.5小时时间窗内未溶栓急性轻型卒中（NIHSS≤5）90天不良预后的患者。研究目的是评估4.5小时时间窗内未溶栓的急性轻型卒中患者90天功能预后，并试图寻找影响不良预后的可能因素。

The data were tested for normal distribution using the Kolmogorov– Smirnov test. Continuous variables with normal distribution were described as mean ± standard deviation (SD) or as median with interquartile range (IQR) otherwise, and differences were assessed using the t-test if normally distributed or Mann–Whitney U test. Categorical variables were expressed as frequencies with percentages, and the χ2 analysis or Fisher exact test was performed to compare the difference between groups. Three different multivariable-adjusted logistic regression models were used to balance the influence of covariates on the associations between IV t-PA and dichotomous outcomes. Model 1 adjusted age, sex, ethnicity, and baseline NIHSS. Model 2 additionally adjusted medical insurance, onset to door time, arrival modality, current smoking, hypertension, diabetes mellitus, hyperlipidemia, prior CHD, AF, heart failure, prior stroke/TIA, carotid stenosis, PVD, SBP at admission, stroke unit, antiplatelet, anti-coagulant, antihypertensive, lipid-lowering agents, glucose-lowering agents, and TOAST subtype. Model 3 adjusted factors in model 2 plus sEICAS ≥ 50%. Subgroup analyses were conducted in patients with a history of baseline NIHSS (0–2 and 3–5), final diagnosis of ischemic stroke, and sEICAS to determine the association of intra- venous alteplase with functional outcomes. Last, propensity score matching (PSM) analysis was undertaken to balance the baseline characteristics in the whole cohort. And 1:1 matching was con- ducted based on the nearest-neighbor matching technique with a caliper width of 0.25. Two-sided p < 0.05 was indicated as statistically significant. All analyses were carried out using the SAS, version 9.4, software (SAS Institute).