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氨甲环酸治疗急性创伤性脑损伤的疗效和安全性:一项随机对照试验的荟萃分析。

Efficacy and safety of tranexamic acid in acute traumatic brain injury: A meta-analysis of randomized controlled trials.

机构信息

Department of Neurology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin, China.

Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China; Key Laboratory of Post Neuro-Injury Neuro-Repair and Regeneration in Central NervousSystem, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Ministry of Education, Tianjin, China.

出版信息

Am J Emerg Med. 2024 Jun;80:35-43. doi: 10.1016/j.ajem.2024.03.005. Epub 2024 Mar 13.

DOI:10.1016/j.ajem.2024.03.005
PMID:38502985
Abstract

INTRODUCTION

Tranexamic acid (TXA) holds a pivotal role in the therapeutic approach to traumatic conditions. Nevertheless, its precise influence on diminishing mortality and limiting the progression of intracranial hemorrhage (ICH) during the treatment of traumatic brain injury (TBI) remains indeterminate.

METHODS

PubMed, EMBASE, Cochrane Library, and Web of Science were searched for randomized controlled trials that compared TXA and a placebo in adults with TBI up to September 31, 2023. Two authors independently abstracted the data and assessed the quality of evidence. Additionally, subgroup analyses were performed to assess outcomes with low heterogenety.

RESULTS

Our search strategy yielded 11,299 patients from 11 studies. The result showed that TXA had no effect on mortality (RR 0.93 [0.86, 1.00], p = 0.06; I: 0%, p = 0.79), poor clinical outcomes (RR 0.92 [0.78, 1.09], p = 0.34; I: 0%, p = 0.40), adverse events (RR 0.94 [0.83, 1.07], p = 0.34; I: 48%, p = 0.10), vascular occlusive events (RR 0.85 [0.68, 1.06], p = 0.16; I: 32%, p = 0.22), pulmonary embolism (RR 0.76 [0.47, 1.22], p = 0.26; I: 0%, p = 0.83), seizure (RR 1.11 [0.92, 1.35], p = 0.27; I: 0%, p = 0.49) and hemorrhagic complications (RR 0.78 [0.55, 1.09], p = 0.14; I: 0%, p = 0.42). TXA might reduce the rate of hemorrhagic expansion (RR 0.83 [0.70, 0.99], p = 0.03; I: 18%, p = 0.29) and mean hemorrhage volume (SMD -0.39 [-0.60, -0.18], p <0.001; I: 44%, p = 0.13).When the time interval from symptom onset to treatment was <3 h, TXA reduced mean hemorrhage volume (SMD -0.51 [-0.81, -0.20], p = 0.001; I: 0%, p = 0.94).

CONCLUSIONS

TXA did not elevate the risk of adverse event, however, the lack of reduction in mortality and the poor clinical outcomes constrain the value of clinical application. Early administration of TXA (within 3 h) may significantly decrease the likelihood of ICH growth in patients with TBI.

摘要

简介

氨甲环酸(TXA)在创伤性疾病的治疗方法中起着关键作用。然而,在治疗创伤性脑损伤(TBI)时,TXA 对降低死亡率和限制颅内出血(ICH)进展的确切影响仍不确定。

方法

检索了截至 2023 年 9 月 31 日PubMed、EMBASE、Cochrane Library 和 Web of Science 中比较 TXA 和安慰剂治疗 TBI 成人的随机对照试验。两位作者独立提取数据并评估证据质量。此外,还进行了亚组分析,以评估低异质性结局。

结果

我们的检索策略从 11 项研究中获得了 11299 名患者。结果表明,TXA 对死亡率(RR 0.93 [0.86, 1.00],p=0.06;I:0%,p=0.79)、不良临床结局(RR 0.92 [0.78, 1.09],p=0.34;I:0%,p=0.40)、不良事件(RR 0.94 [0.83, 1.07],p=0.34;I:48%,p=0.10)、血管闭塞事件(RR 0.85 [0.68, 1.06],p=0.16;I:32%,p=0.22)、肺栓塞(RR 0.76 [0.47, 1.22],p=0.26;I:0%,p=0.83)、癫痫发作(RR 1.11 [0.92, 1.35],p=0.27;I:0%,p=0.49)和出血性并发症(RR 0.78 [0.55, 1.09],p=0.14;I:0%,p=0.42)没有影响。TXA 可能降低出血扩大的发生率(RR 0.83 [0.70, 0.99],p=0.03;I:18%,p=0.29)和平均出血体积(SMD -0.39 [-0.60, -0.18],p<0.001;I:44%,p=0.13)。当症状发作至治疗的时间间隔<3 小时时,TXA 降低了平均出血体积(SMD -0.51 [-0.81, -0.20],p=0.001;I:0%,p=0.94)。

结论

TXA 并未增加不良事件的风险,但死亡率降低和不良临床结局的缺乏限制了其临床应用的价值。TXA 的早期给药(3 小时内)可能显著降低 TBI 患者 ICH 增长的可能性。

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