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创伤患者院前使用氨甲环酸的有效性和安全性:更新的系统评价和荟萃分析及试验序贯分析。

Effectiveness and safety of prehospital tranexamic acid in patients with trauma: an updated systematic review and meta-analysis with trial sequential analysis.

机构信息

Department of Orthopedics, People's Hospital of Nanchuan District, Nanchuan District, Chongqing, 408400, China.

出版信息

BMC Emerg Med. 2024 Oct 25;24(1):202. doi: 10.1186/s12873-024-01119-2.

DOI:10.1186/s12873-024-01119-2
PMID:39455930
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11515107/
Abstract

BACKGROUND

The use of prehospital tranexamic acid (TXA) in patients with trauma has attracted considerable attention. This systematic review and meta-analysis aimed to provide the best evidence for clinicians.

METHODS

All related literature in PubMed, Embase, and the Cochrane Central Register of Controlled Trials (Central) databases were searched systematically from their establishment to July 1, 2023. The outcome measures included 24-hour and 28-30-day mortality and adverse events (multiple organ dysfunction syndrome, acute respiratory distress syndrome, thrombotic events, and infection events). The Revised Cochrane Risk of Bias Tool for Randomized Trials was used to evaluate the quality of the randomized controlled trials (RCTs). The Methodological Index for Nonrandomized Studies (MINORS) was used to evaluate the risk of bias in non-RCTs. The required information size was estimated using trial sequential analysis. The Grading of Recommendations, Assessment, Development, and Evaluation approach was used to evaluate the evidence quality.

RESULTS

Eleven studies (comprising 11,259 patients) were included; two of these were RCTs. The overall risks of bias were low in the RCTs. ROBINS-I risk of bias was Moderate in 3 studies, serious in 5 studies, and critical in 1 study. A significant reduction in 24-hour mortality was observed (odds ratio [OR], 0.82; 95% confidence interval [CI], 0.71-0.94). A subgroup analysis that included only RCTs revealed that prehospital TXA was associated with reduced 28-30-day mortality (OR, 0.80; 95% CI, 0.66-0.97) and increased risks of thromboembolism (OR, 1.22; 95% CI, 1.03-1.44) and infection (OR, 1.13; 95% CI, 1.00-1.28) events. The blood products for transfusion decreased by 2.3 units on average (weighted mean difference [WMD], - 2.30; 95%CI, - 3.59 to - 1.01).

CONCLUSIONS

This updated systematic review showed that prehospital TXA reduced the 24-hour and 28-38-day mortality and blood transfusion but increased the risks of infection and thromboembolism in patients with trauma. Future RCTs with larger and more homogeneous samples will help verify our results.

摘要

背景

创伤患者使用院前氨甲环酸(TXA)引起了广泛关注。本系统评价和荟萃分析旨在为临床医生提供最佳证据。

方法

系统检索 PubMed、Embase 和 Cochrane 中心对照试验注册库(Central)从建库至 2023 年 7 月 1 日的相关文献。结局指标包括 24 小时和 28-30 天死亡率和不良事件(多器官功能障碍综合征、急性呼吸窘迫综合征、血栓事件和感染事件)。采用修订后的 Cochrane 随机对照试验偏倚风险工具评估随机对照试验(RCT)的质量。采用非随机研究方法学指数(MINORS)评估非 RCT 的偏倚风险。采用试验序贯分析估计所需信息量。采用推荐、评估、发展和评估方法评估证据质量。

结果

纳入 11 项研究(共 11259 例患者),其中 2 项为 RCT。RCT 的整体偏倚风险较低。3 项研究的 ROBINS-I 偏倚风险为中度,5 项研究为严重,1 项研究为关键。24 小时死亡率显著降低(比值比 [OR],0.82;95%置信区间 [CI],0.71-0.94)。仅纳入 RCT 的亚组分析显示,院前 TXA 与降低 28-30 天死亡率(OR,0.80;95%CI,0.66-0.97)和增加血栓栓塞(OR,1.22;95%CI,1.03-1.44)和感染(OR,1.13;95%CI,1.00-1.28)事件风险相关。平均输血的血液制品减少 2.3 单位(加权均数差 [WMD],-2.30;95%CI,-3.59 至-1.01)。

结论

本更新的系统评价表明,院前 TXA 降低了创伤患者的 24 小时和 28-38 天死亡率和输血需求,但增加了感染和血栓栓塞的风险。未来需要更大和更同质样本的 RCT 来帮助验证我们的结果。

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本文引用的文献

1
Prehospital Tranexamic Acid for Severe Trauma.创伤院前氨甲环酸治疗严重创伤。
N Engl J Med. 2023 Jul 13;389(2):127-136. doi: 10.1056/NEJMoa2215457. Epub 2023 Jun 14.
2
Pre-hospital tranexamic acid administration in patients with a severe hemorrhage: an evaluation after the implementation of tranexamic acid administration in the Dutch pre-hospital protocol.院前氨甲环酸治疗严重出血患者:荷兰院前方案实施氨甲环酸治疗后的评估。
Eur J Trauma Emerg Surg. 2024 Feb;50(1):139-147. doi: 10.1007/s00068-023-02262-4. Epub 2023 Apr 17.
3
The effect of prehospital tranexamic acid on outcome in polytrauma patients with associated severe brain injury.
院前氨甲环酸对伴有严重脑损伤的多发伤患者结局的影响。
Eur J Trauma Emerg Surg. 2022 Jun;48(3):1589-1599. doi: 10.1007/s00068-021-01827-5. Epub 2021 Nov 14.
4
The impact of prehospital tranexamic acid on mortality and transfusion requirements: match-pair analysis from the nationwide German TraumaRegister DGU®.院前氨甲环酸对死亡率和输血需求的影响:来自全国性德国创伤登记处 DGU®的配对分析。
Crit Care. 2021 Aug 4;25(1):277. doi: 10.1186/s13054-021-03701-7.
5
Does Liberal Prehospital and In-Hospital Tranexamic Acid Influence Outcome in Severely Injured Patients? A Prospective Cohort Study.自由使用院前和院内氨甲环酸是否影响严重创伤患者的结局?一项前瞻性队列研究。
World J Surg. 2021 Aug;45(8):2398-2407. doi: 10.1007/s00268-021-06143-y. Epub 2021 Apr 29.
6
Association of Intravenous Tranexamic Acid With Thromboembolic Events and Mortality: A Systematic Review, Meta-analysis, and Meta-regression.静脉注射氨甲环酸与血栓栓塞事件及死亡率的关联:一项系统评价、荟萃分析和Meta回归分析
JAMA Surg. 2021 Apr 14;156(6):e210884. doi: 10.1001/jamasurg.2021.0884.
7
PRISMA Reporting Guidelines for Meta-analyses and Systematic Reviews.系统评价与Meta分析的PRISMA报告指南。
JAMA Surg. 2021 Aug 1;156(8):789-790. doi: 10.1001/jamasurg.2021.0546.
8
The impact of prehospital TXA on mortality among bleeding trauma patients: A systematic review and meta-analysis.院前使用氨甲环酸对出血性创伤患者死亡率的影响:系统评价和荟萃分析。
J Trauma Acute Care Surg. 2021 May 1;90(5):901-907. doi: 10.1097/TA.0000000000003120.
9
Association Between Prehospital Tranexamic Acid Administration and Outcomes of Severe Traumatic Brain Injury.院前氨甲环酸给药与严重创伤性脑损伤结局的关系。
JAMA Neurol. 2021 Mar 1;78(3):338-345. doi: 10.1001/jamaneurol.2020.4596.
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JAMA Surg. 2020 Oct 5;156(1):11-20. doi: 10.1001/jamasurg.2020.4350.