ICH 一年后的结果:氨甲环酸治疗脑内出血 2 (TICH-2) 试验的数据。

IF 5.8 3区 医学 Q1 CLINICAL NEUROLOGY
Zhe Kang Law, Chaamanti Sivakumar Menon, Lisa J Woodhouse, Jason Philip Appleton, Rustam Al-Shahi Salman, Thompson Robinson, David Werring, Christine Roffe, Robert A Dineen, Philip Michael Bath, Nikola Sprigg
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引用次数: 0

摘要

简介氨甲环酸治疗脑内出血-2(TICH-2)试验报告称,尽管血肿扩大、早期神经功能恶化和早期死亡的情况有所缓解,但第 90 天的死亡和依赖性并无明显改善。然而,中风(尤其是脑内出血(ICH))后的明显康复可能需要 3 个月以上的时间。在此,我们报告了参与者在中风后 1 年的结果:TICH-2 是一项前瞻性随机对照试验,测试了氨甲环酸在发病 8 小时内用于自发性 ICH 的有效性和安全性。正在接受抗凝治疗的ICH患者被排除在外。对来自英国的患者进行了为期一年的集中盲法电话随访。主要结果是 1 年后的修改后兰金量表。次要结果包括巴特尔指数、电话访谈认知状态修正量表、EuroQoL-5D 和 Zung 抑郁量表。这是TICH-2试验的预设二次分析:试验共招募了约 2325 名患者(年龄为 68.9 ± 13.8 岁;1301 名男性,占 56%)。约 1910 名参与者(82.2%)符合第 365 天随访条件。57名患者(3.0%)失去了随访机会。氨甲环酸并未降低1年后不良功能预后的风险(调整后OR 0.91 95% CI 0.77-1.09; p = 0.302)。然而,Cox比例危险分析显示,氨甲环酸组的生存率显著提高(调整后HR为0.83,95% CI为0.70-0.99;P = 0.038):结论:ICH术后1年的功能预后没有差异。氨甲环酸可降低1年后的死亡率,但不会增加严重依赖性幸存者的人数。但由于这是一项中性试验的二次分析结果,因此应谨慎解读。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Outcome 1 year after ICH: Data from the Tranexamic acid for IntraCerebral Haemorrhage 2 (TICH-2) trial.

Introduction: The Tranexamic acid for IntraCerebral Haemorrhage-2 (TICH-2) trial reported no significant improvement in death and dependency at day 90 despite reductions in haematoma expansion, early neurological deterioration and early death. However, significant recovery after stroke, particularly intracerebral haemorrhage (ICH), may take more than 3 months. Here we report the participant outcomes at 1 year after stroke.

Patients and methods: TICH-2 was a prospective randomised controlled trial that tested the efficacy and safety of tranexamic acid in spontaneous ICH when given within 8 h of onset. Patients with ICH on anticoagulation were excluded. Centralised blinded telephone follow up was performed for patients from the United Kingdom at 1 year. The primary outcome was modified Rankin Scale at 1 year. Secondary outcomes included Barthel index, Telephone Interview Cognitive Status-modified, EuroQoL-5D and Zung Depression Scale. This was a prespecified secondary analysis of the TICH-2 trial.

Results: About 2325 patients were recruited into the trial (age 68.9 ± 13.8 years; 1301 male, 56%). About 1910 participants (82.2%) were eligible for day 365 follow up. 57 patients (3.0%) were lost to follow up. Tranexamic acid did not reduce the risk of poor functional outcome at 1 year (adjusted OR 0.91 95% CI 0.77-1.09; p = 0.302). However, Cox proportional hazard analysis revealed significant survival benefit in the tranexamic acid group (adjusted HR 0.83, 95% CI 0.70-0.99; p = 0.038).

Conclusion: There was no difference in functional outcome at 1 year after ICH. Tranexamic acid may reduce mortality at 1 year without an increase in severely dependent survivors. But this should be interpreted with caution as this is a result of secondary analysis in a neutral trial.

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来源期刊
CiteScore
7.50
自引率
6.60%
发文量
102
期刊介绍: Launched in 2016 the European Stroke Journal (ESJ) is the official journal of the European Stroke Organisation (ESO), a professional non-profit organization with over 1,400 individual members, and affiliations to numerous related national and international societies. ESJ covers clinical stroke research from all fields, including clinical trials, epidemiology, primary and secondary prevention, diagnosis, acute and post-acute management, guidelines, translation of experimental findings into clinical practice, rehabilitation, organisation of stroke care, and societal impact. It is open to authors from all relevant medical and health professions. Article types include review articles, original research, protocols, guidelines, editorials and letters to the Editor. Through ESJ, authors and researchers have gained a new platform for the rapid and professional publication of peer reviewed scientific material of the highest standards; publication in ESJ is highly competitive. The journal and its editorial team has developed excellent cooperation with sister organisations such as the World Stroke Organisation and the International Journal of Stroke, and the American Heart Organization/American Stroke Association and the journal Stroke. ESJ is fully peer-reviewed and is a member of the Committee on Publication Ethics (COPE). Issues are published 4 times a year (March, June, September and December) and articles are published OnlineFirst prior to issue publication.
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