血压与氨甲环酸对自发性脑出血的影响：一项大型随机对照试验的二次分析
Effects of blood pressure and tranexamic acid in spontaneous intracerebral haemorrhage: a secondary analysis of a large randomised controlled trial.
作者信息
Appleton Jason Philip, Law Zhe Kang, Woodhouse Lisa Jane, Al-Shahi Salman Rustam, Beridze Maia, Christensen Hanne, Dineen Robert A, Guerrero Juan José Egea, England Timothy J, Karlinski Michal, Krishnan Kailash, Laska Ann Charlotte, Lyrer Philippe, Ozturk Serefnur, Roffe Christine, Roberts Ian, Robinson Thompson G, Scutt Polly, Werring David J, Bath Philip M, Sprigg Nikola
机构信息
Stroke, Nottingham University Hospitals NHS Trust, Nottingham, UK.
Stroke Trials Unit, Mental Health and Clinical Neurosciences, University of Nottingham, Nottingham, UK.
出版信息
BMJ Neurol Open. 2023 Jun 12;5(1):e000423. doi: 10.1136/bmjno-2023-000423. eCollection 2023.
BACKGROUND
Tranexamic acid reduced haematoma expansion and early death, but did not improve functional outcome in the tranexamic acid for hyperacute spontaneous intracerebral haemorrhage-2 (TICH-2) trial. In a predefined subgroup, there was a statistically significant interaction between prerandomisation baseline systolic blood pressure (SBP) and the effect of tranexamic acid on functional outcome (p=0.019).
METHODS
TICH-2 was an international prospective double-blind placebo-controlled randomised trial evaluating intravenous tranexamic acid in patients with acute spontaneous intracerebral haemorrhage (ICH). Prerandomisation baseline SBP was split into predefined ≤170 and >170 mm Hg groups. The primary outcome at day 90 was the modified Rankin Scale (mRS), a measure of dependency, analysed using ordinal logistic regression. Haematoma expansion was defined as an increase in haematoma volume of >33% or >6 mL from baseline to 24 hours. Data are OR or common OR (cOR) with 95% CIs, with significance at p<0.05.
RESULTS
Of 2325 participants in TICH-2, 1152 had baseline SBP≤170 mm Hg and were older, had larger lobar haematomas and were randomised later than 1173 with baseline SBP>170 mm Hg. Tranexamic acid was associated with a favourable shift in mRS at day 90 in those with baseline SBP≤170 mm Hg (cOR 0.73, 95% CI 0.59 to 0.91, p=0.005), but not in those with baseline SBP>170 mm Hg (cOR 1.05, 95% CI 0.85 to 1.30, p=0.63). In those with baseline SBP≤170 mm Hg, tranexamic acid reduced haematoma expansion (OR 0.62, 95% CI 0.47 to 0.82, p=0.001), but not in those with baseline SBP>170 mm Hg (OR 1.02, 95% CI 0.77 to 1.35, p=0.90).
CONCLUSIONS
Tranexamic acid was associated with improved clinical and radiological outcomes in ICH patients with baseline SBP≤170 mm Hg. Further research is needed to establish whether certain subgroups may benefit from tranexamic acid in acute ICH.
TRIAL REGISTRATION NUMBER
ISRCTN93732214.
背景
在急性自发性脑出血-2（TICH-2）试验中，氨甲环酸可减少血肿扩大和早期死亡，但未改善功能结局。在一个预先定义的亚组中，随机分组前的基线收缩压（SBP）与氨甲环酸对功能结局的影响之间存在统计学上的显著交互作用（p=0.019）。
方法
TICH-2是一项国际前瞻性双盲安慰剂对照随机试验，评估急性自发性脑出血（ICH）患者静脉注射氨甲环酸的效果。随机分组前的基线SBP被分为预先定义的≤170 mmHg和>170 mmHg组。90天时的主要结局是改良Rankin量表（mRS），这是一种依赖程度的测量方法，使用有序逻辑回归进行分析。血肿扩大定义为从基线到24小时血肿体积增加>33%或>6 mL。数据为比值比（OR）或共同比值比（cOR）及95%置信区间（CI），p<0.05时有统计学意义。
结果
在TICH-2的2325名参与者中，1152名基线SBP≤170 mmHg，他们年龄更大，脑叶血肿更大，且随机分组时间晚于1173名基线SBP>170 mmHg的参与者。氨甲环酸与基线SBP≤170 mmHg的患者在90天时mRS的有利变化相关（cOR 0.73，95%CI 0.59至0.91，p=0.005），但与基线SBP>170 mmHg的患者无关（cOR 1.05，95%CI 0.85至1.30，p=0.63）。在基线SBP≤170 mmHg的患者中，氨甲环酸减少了血肿扩大（OR 0.62，95%CI 0.47至0.82，p=0.001），但在基线SBP>170 mmHg的患者中未减少（OR 1.02，95%CI 0.77至1.35，p=0.90）。
结论
氨甲环酸与基线SBP≤170 mmHg的ICH患者临床和影像学结局改善相关。需要进一步研究确定某些亚组在急性ICH中是否可能从氨甲环酸中获益。
试验注册号
ISRCTN93732214。
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