Division of Emergency Medicine, Department of Medicine, McMaster University, Hamilton, ON, Canada.
Division of Critical Care, Department of Medicine, McMaster University, Hamilton, ON, Canada.
Intensive Care Med. 2021 Jan;47(1):14-27. doi: 10.1007/s00134-020-06279-w. Epub 2020 Oct 20.
With the publication of a large randomized-controlled trial (RCT) suggesting that tranexamic acid (TXA) may improve head-injury-related deaths, we aimed to determine the safety and efficacy of TXA in acute traumatic brain injury (TBI).
In this systematic review and meta-analysis, we searched MEDLINE, PubMed, EMBASE, CINHAL, ACPJC, Google Scholar, and unpublished sources from inception until June 24, 2020 for randomized-controlled trials comparing TXA and placebo in adults and adolescents (≥ 15 years of age) with acute TBI. We screened studies and extracted summary estimates independently and in duplicate. We assessed the quality of evidence using the grading of recommendations assessment, development, and evaluation approach. This study is registered with PROSPERO (CRD42020164232).
Nine RCTs enrolled 14,747 patients. Compared to placebo, TXA had no effect on mortality (RR 0.95; 95% CI 0.88-1.02; RD 1.0% reduction; 95% CI 2.5% reduction to 0.4% increase, moderate certainty) or disability assessed by the Disability Rating Scale (MD, - 0.18 points; 95% CI - 0.43 to 0.08; moderate certainty). TXA may reduce hematoma expansion on subsequent imaging (RR 0.77; 95% CI 0.58-1.03, RD 3.6%, 95% CI 6.6% reduction to 0.5% increase, low certainty). Risks of adverse events (all moderate, low, or very low certainty) were similar between placebo and TXA.
In patients with acute TBI, TXA probably has no effect on mortality or disability. TXA may decrease hematoma expansion on subsequent imaging; however, this outcome is likely of less importance to patients. The use of TXA probably does not increase the risk of adverse events.
随着一项大型随机对照试验（RCT）的发表，该试验表明氨甲环酸（TXA）可能改善颅脑损伤相关死亡，我们旨在确定 TXA 在急性创伤性脑损伤（TBI）中的安全性和疗效。
在这项系统评价和荟萃分析中，我们检索了 MEDLINE、PubMed、EMBASE、CINHAL、ACPJC、Google Scholar 和 2020 年 6 月 24 日之前未发表的资源，以比较 TXA 和安慰剂在成人和青少年（≥15 岁）急性 TBI 中的随机对照试验。我们独立并重复筛选研究和提取汇总估计。我们使用推荐评估、制定和评估方法的分级来评估证据质量。本研究在 PROSPERO（CRD42020164232）注册。
9 项 RCT 纳入了 14747 名患者。与安慰剂相比，TXA 对死亡率（RR 0.95；95%CI 0.88-1.02；RD 1.0%降低；95%CI 2.5%降低至 0.4%增加，中等确定性）或残疾评定量表评估的残疾（MD，-0.18 分；95%CI -0.43 至 0.08；中等确定性）没有影响。TXA 可能减少随后影像学检查的血肿扩大（RR 0.77；95%CI 0.58-1.03，RD 3.6%，95%CI 6.6%降低至 0.5%增加，低确定性）。安慰剂和 TXA 之间不良事件的风险（均为中等、低或极低确定性）相似。
在急性 TBI 患者中，TXA 可能对死亡率或残疾没有影响。TXA 可能减少随后影像学检查的血肿扩大；然而，这一结果对患者可能不太重要。TXA 的使用可能不会增加不良事件的风险。
