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抗血小板相关脑出血患者的 TICH-2 随机对照试验结果。

Outcomes in Antiplatelet-Associated Intracerebral Hemorrhage in the TICH-2 Randomized Controlled Trial.

机构信息

Stroke Trials Unit Division of Clinical Neuroscience University of Nottingham United Kingdom.

Department of Medicine National University of Malaysia Kuala Lumpur Malaysia.

出版信息

J Am Heart Assoc. 2021 Feb;10(5):e019130. doi: 10.1161/JAHA.120.019130. Epub 2021 Feb 15.

Abstract

Background Antiplatelet therapy increases the risk of hematoma expansion in intracerebral hemorrhage (ICH) while the effect on functional outcome is uncertain. Methods and Results This is an exploratory analysis of the TICH-2 (Tranexamic Acid in Intracerebral Hemorrhage-2) double-blind, randomized, placebo-controlled trial, which studied the efficacy of tranexamic acid in patients with spontaneous ICH within 8 hours of onset. Multivariable logistic regression and ordinal regression were performed to explore the relationship between pre-ICH antiplatelet therapy, and 24-hour hematoma expansion and day 90 modified Rankin Scale score, as well as the effect of tranexamic acid. Of 2325 patients, 611 (26.3%) had pre-ICH antiplatelet therapy. They were older (mean age, 75.7 versus 66.5 years), more likely to have ischemic heart disease (25.4% versus 2.7%), ischemic stroke (36.2% versus 6.3%), intraventricular hemorrhage (40.2% versus 27.5%), and larger baseline hematoma volume (mean, 28.1 versus 22.6 mL) than the no-antiplatelet group. Pre-ICH antiplatelet therapy was associated with a significantly increased risk of hematoma expansion (adjusted odds ratio [OR], 1.28; 95% CI, 1.01-1.63), a shift toward unfavorable outcome in modified Rankin Scale (adjusted common OR, 1.58; 95% CI, 1.32-1.91) and a higher risk of death at day 90 (adjusted OR, 1.63; 95% CI, 1.25-2.11). Tranexamic acid reduced the risk of hematoma expansion in the overall patients with ICH (adjusted OR, 0.76; 95% CI, 0.62-0.93) and antiplatelet subgroup (adjusted OR, 0.61; 95% CI, 0.41-0.91) with no significant interaction between pre-ICH antiplatelet therapy and tranexamic acid (P interaction=0.248). Conclusions Antiplatelet therapy is independently associated with hematoma expansion and unfavorable functional outcome. Tranexamic acid reduced hematoma expansion regardless of prior antiplatelet therapy use. Registration URL: https://www.isrctn.com; Unique identifier: ISRCTN93732214.

摘要

背景

抗血小板治疗会增加颅内出血(ICH)患者血肿扩大的风险,但对功能结局的影响尚不确定。

方法和结果

这是一项对 TICH-2(氨甲环酸治疗脑出血-2)双盲、随机、安慰剂对照试验的探索性分析,该试验研究了氨甲环酸在ICH 发病后 8 小时内的自发性 ICH 患者中的疗效。采用多变量逻辑回归和有序回归分析探讨了ICH 前抗血小板治疗与 24 小时血肿扩大和第 90 天改良 Rankin 量表评分的关系,以及氨甲环酸的作用。在 2325 例患者中,611 例(26.3%)有 ICH 前抗血小板治疗。与无抗血小板组相比,他们年龄更大(平均年龄 75.7 岁 vs 66.5 岁)、更易发生缺血性心脏病(25.4% vs 2.7%)、缺血性脑卒中(36.2% vs 6.3%)、脑室内出血(40.2% vs 27.5%)和基线血肿体积更大(平均 28.1 vs 22.6 ml)。ICH 前抗血小板治疗与血肿扩大风险显著增加相关(调整后的优势比[OR],1.28;95%可信区间,1.01-1.63),改良 Rankin 量表(调整后的常见 OR,1.58;95%可信区间,1.32-1.91)预后不良的风险增加,90 天死亡率(调整后的 OR,1.63;95%可信区间,1.25-2.11)也更高。氨甲环酸降低了总体 ICH 患者(调整后的 OR,0.76;95%可信区间,0.62-0.93)和抗血小板亚组(调整后的 OR,0.61;95%可信区间,0.41-0.91)的血肿扩大风险,ICH 前抗血小板治疗与氨甲环酸之间无显著交互作用(P 交互=0.248)。

结论

抗血小板治疗与血肿扩大和不良功能结局独立相关。氨甲环酸降低了血肿扩大的风险,无论是否使用 ICH 前抗血小板治疗。

注册网址

https://www.isrctn.com;唯一标识符:ISRCTN93732214。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9755/8174262/0a7d97d44215/JAH3-10-e019130-g001.jpg

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