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氨甲环酸治疗脑出血——当前证据及正在进行的试验综述

Treatment of intracerebral haemorrhage with tranexamic acid - A review of current evidence and ongoing trials.

作者信息

Law Zhe Kang, Meretoja Atte, Engelter Stefan T, Christensen Hanne, Muresan Eugenia-Maria, Glad Solveig B, Liu Liping, Bath Philip M, Sprigg Nikola

机构信息

Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, UK.

Department of Medicine, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.

出版信息

Eur Stroke J. 2017 Mar;2(1):13-22. doi: 10.1177/2396987316676610. Epub 2016 Oct 26.

Abstract

PURPOSE

Haematoma expansion is a devastating complication of intracerebral haemorrhage (ICH) with no established treatment. Tranexamic acid had been an effective haemostatic agent in reducing post-operative and traumatic bleeding. We review current evidence examining the efficacy of tranexamic acid in improving clinical outcome after ICH.

METHOD

We searched MEDLINE, EMBASE, CENTRAL and clinical trial registers for studies using search strategies incorporating the terms 'intracerebral haemorrhage', 'tranexamic acid' and 'antifibrinolytic'. Authors of ongoing clinical trials were contacted for further details.

FINDINGS

We screened 268 publications and retrieved 17 articles after screening. Unpublished information from three ongoing clinical trials was obtained. We found five completed studies. Of these, two randomised controlled trials (RCTs) comparing intravenous tranexamic acid to placebo ( = 54) reported no significant difference in death or dependency. Three observational studies ( = 281) suggested less haematoma growth with rapid tranexamic acid infusion. There are six ongoing RCTs ( = 3089) with different clinical exclusions, imaging selection criteria (spot sign and haematoma volume), time window for recruitment and dosing of tranexamic acid.

DISCUSSION

Despite their heterogeneity, the ongoing trials will provide key evidence on the effects of tranexamic acid on ICH. There are uncertainties of whether patients with negative spot sign, large haematoma, intraventricular haemorrhage, or poor Glasgow Coma Scale should be recruited. The time window for optimal effect of haemostatic therapy in ICH is yet to be established.

CONCLUSION

Tranexamic acid is a promising haemostatic agent for ICH. We await the results of the trials before definite conclusions can be drawn.

摘要

目的

血肿扩大是脑出血(ICH)的一种严重并发症,目前尚无既定的治疗方法。氨甲环酸一直是一种有效的止血剂,可减少术后出血和创伤性出血。我们综述了目前关于氨甲环酸改善脑出血后临床结局疗效的证据。

方法

我们检索了MEDLINE、EMBASE、CENTRAL和临床试验注册库,以查找使用包含“脑出血”、“氨甲环酸”和“抗纤维蛋白溶解剂”等术语的检索策略的研究。我们联系了正在进行的临床试验的作者以获取更多详细信息。

结果

我们筛选了268篇出版物,筛选后检索到17篇文章。我们获得了三项正在进行的临床试验的未发表信息。我们找到了五项完成的研究。其中,两项比较静脉注射氨甲环酸与安慰剂(n = 54)的随机对照试验(RCT)报告称,在死亡或依赖方面无显著差异。三项观察性研究(n = 281)表明,快速输注氨甲环酸可减少血肿增长。有六项正在进行的RCT(n = 3089),其临床排除标准、影像选择标准(斑点征和血肿体积)、招募时间窗以及氨甲环酸的给药方式各不相同。

讨论

尽管这些试验存在异质性,但正在进行的试验将提供关于氨甲环酸对脑出血影响的关键证据。对于斑点征阴性、血肿较大、脑室内出血或格拉斯哥昏迷量表评分较低的患者是否应纳入研究仍存在不确定性。脑出血止血治疗的最佳效果时间窗尚未确定。

结论

氨甲环酸是一种有前景的脑出血止血剂。在得出明确结论之前,我们等待试验结果。

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