Department of Medicine, Baerum Hospital, Vestre Viken Hospital Trust, Drammen, Norway.
Oslo Stroke Unit, Department of Neurology, Oslo University Hospital, Ullevål, Norway.
Eur J Neurol. 2022 Feb;29(2):609-614. doi: 10.1111/ene.15126. Epub 2021 Oct 4.
Sex differences in acute ischemic stroke is of increasing interest in the era of precision medicine. We aimed to explore sex disparities in baseline characteristics, management and outcomes in patients treated with intravenous thrombolysis included in the Norwegian Tenecteplase trial (NOR-TEST).
NOR-TEST was an open-label, randomized, blinded endpoint trial, performed from 2012 to 2016, comparing treatment with tenecteplase to treatment with alteplase within 4.5 h after acute ischemic stroke symptom onset. Sex differences at baseline, treatment and outcomes were compared using multivariable logistic regression models. Heterogeneity in treatment was evaluated by including an interaction term in the model.
Of 1100 patients enrolled, 40% were women, and in patients aged >80 years, the proportion of women was greater than men (19% vs. 14%; p = 0.02). Women had a lower burden of cardiovascular risk factors, such as diabetes mellitus (11% vs. 15%; p = 0.05) and a higher mean high-density lipoprotein cholesterol level (1.7 ± 0.6 mmol/L vs. 1.3 ± 0.4 mmol/L; p < 0.001), and a higher proportion of women had never smoked (45% vs. 33%; p < 0.001) compared with men. While there was no sex difference in time from onset of symptoms to admission, door to needle time or in-hospital workup, women were admitted with more severe stroke (National Institutes of Health Stroke Scale [NIHSS] score 6.2 ± 5.6 vs. 5.3 ± 5.1; p = 0.01). Stroke mimic diagnosis was more common in women (21% vs. 15%; p = 0.01). There were no significant sex differences in clinical outcome, measured by the NIHSS, the modified Rankin Scale, intracranial hemorrhage and mortality.
Women were underrepresented in number in NOR-TEST. The included women had a lower cardiovascular risk factor burden and more severe strokes.
精准医学时代，急性缺血性脑卒中的性别差异日益受到关注。本研究旨在探讨纳入挪威替奈普酶试验（NOR-TEST）的静脉溶栓治疗患者的基线特征、治疗和结局的性别差异。
NOR-TEST 是一项开放标签、随机、盲终点试验，于 2012 年至 2016 年进行，比较了急性缺血性脑卒中症状发作后 4.5 小时内使用替奈普酶与使用阿替普酶的治疗效果。使用多变量逻辑回归模型比较基线、治疗和结局的性别差异。通过在模型中包含交互项来评估治疗的异质性。
在纳入的 1100 例患者中，40%为女性，80 岁以上患者中，女性比例高于男性（19%比 14%；p=0.02）。女性的心血管危险因素负担较低，如糖尿病（11%比 15%；p=0.05）和平均高密度脂蛋白胆固醇水平较高（1.7±0.6mmol/L 比 1.3±0.4mmol/L；p<0.001），且从不吸烟的女性比例较高（45%比 33%；p<0.001）。虽然女性从症状发作到入院、门到针时间或住院检查的时间没有性别差异，但女性入院时的卒中严重程度更高（NIHSS 评分 6.2±5.6 比 5.3±5.1；p=0.01）。女性的卒中模拟诊断更为常见（21%比 15%；p=0.01）。女性在 NIHSS、改良 Rankin 量表、颅内出血和死亡率等临床结局方面没有显著性别差异。
NOR-TEST 中女性人数相对较少。纳入的女性心血管危险因素负担较低，卒中更严重。
