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静脉注射氨甲环酸与髋部骨折手术中的血栓栓塞事件:一项系统评价与荟萃分析。

Intravenous tranexamic acid and thromboembolic events in hip fracture surgery: A systematic review and meta-analysis.

作者信息

Leverett Gregory D, Marriott Andrew

机构信息

Department of Anaesthesia and Perioperative Medicine, Eastern Health, Victoria, Australia; Department of Medicine and Veterinary Science, University of Edinburgh, Edinburgh, Scotland.

Department of Anaesthetics, Perioperative and Pain Medicine, Barwon Health, Victoria, Australia; Clinical Associate Professor, School of Medicine, IMPACT SRC, Deakin University, Victoria, Australia.

出版信息

Orthop Traumatol Surg Res. 2023 Apr;109(2):103337. doi: 10.1016/j.otsr.2022.103337. Epub 2022 May 25.

DOI:10.1016/j.otsr.2022.103337
PMID:35643364
Abstract

BACKGROUND

Osteoporotic hip fractures are a major health problem in developed countries. Surgical management is the mainstay of treatment for these injuries, and historically presents an increased risk of thromboembolism, blood loss and blood transfusion. Despite the demonstrated safety of tranexamic acid (TXA) in elective hip arthroplasty, there is uncertainty regarding the risk of thromboembolism with the administration of TXA during hip fracture surgery. This study aims to address the following questions regarding patients undergoing traumatic hip fracture surgery: 1. Does intravenous TXA increase the risk of thromboembolic events? 2. Does intravenous TXA reduce peri-operative blood loss? 3. Does intravenous TXA increase the risk of non-thromboembolic complications or post-operative mortality?

METHODS

A literature search of Ovid MEDLINE, Embase, PubMed, the Cochrane Register of Controlled Trials and CINAHL was conducted, assessing results from database inception until the 11th May, 2021. We included randomised controlled trials that investigated perioperative administration of intravenous TXA in patients undergoing hip fracture surgery, compared to a control cohort. We excluded articles published in a language other than English, evaluated elective hip arthroplasty, or did not report thromboembolic events. Included trials were analysed using RevMan v5.3.

RESULTS

Sixteen articles encompassing 1491 patients met inclusion criteria. The risk difference of thromboembolic events in the TXA group was 0.02 (95%C.I. -0.01-0.04; p=0.17). TXA reduced post-operative transfusion rates by 42% (range: 28-54%, p<0.0001). The mean haemoglobin was higher in the TXA group on post-operative day one (0.77g/dL, p<0.0001), day two (0.56g/dL, p<0.0001) and day three (0.42g/dL, p<0.0001). There was no statistically significant difference in non-thromboembolic complications or post-operative mortality across the two cohorts.

DISCUSSION

There is no conclusive evidence from the current published literature that peri-operative intravenous TXA administration increases the risk of thromboembolic events after hip fracture surgery. This meta-analysis reinforces that TXA is effective in reducing post-operative transfusions and haemoglobin decline after hip fracture surgery. This study found that TXA did not increase non-thromboembolic complications or post-operative mortality. Further large-scale studies evaluating thromboembolic complications as a primary outcome are required to definitively establish the safety of TXA in hip fracture surgery.

LEVEL OF EVIDENCE

I; meta-analysis of randomised controlled trials.

摘要

背景

骨质疏松性髋部骨折在发达国家是一个主要的健康问题。手术治疗是这些损伤的主要治疗方法,并且在历史上,此类手术存在血栓栓塞、失血和输血风险增加的情况。尽管氨甲环酸(TXA)在择期髋关节置换术中已被证明是安全的,但在髋部骨折手术中使用TXA时,关于血栓栓塞风险仍存在不确定性。本研究旨在探讨以下有关接受创伤性髋部骨折手术患者的问题:1. 静脉注射TXA是否会增加血栓栓塞事件的风险?2. 静脉注射TXA是否会减少围手术期失血?3. 静脉注射TXA是否会增加非血栓栓塞并发症或术后死亡率的风险?

方法

对Ovid MEDLINE、Embase、PubMed、Cochrane对照试验注册库和CINAHL进行文献检索,评估从数据库建立到2021年5月11日的结果。我们纳入了随机对照试验,这些试验研究了在接受髋部骨折手术的患者中围手术期静脉注射TXA,并与对照组进行比较。我们排除了用非英语发表的文章、评估择期髋关节置换术的文章或未报告血栓栓塞事件的文章。使用RevMan v5.3对纳入的试验进行分析。

结果

16篇文章共纳入1491例患者,符合纳入标准。TXA组血栓栓塞事件的风险差异为0.02(95%置信区间-0.01-0.04;p=0.17)。TXA使术后输血率降低了42%(范围:28%-54%,p<0.0001)。术后第一天(0.77g/dL,p<0.0001)、第二天(0.56g/dL,p<0.0001)和第三天(0.42g/dL,p<0.0001),TXA组的平均血红蛋白水平更高。两组之间在非血栓栓塞并发症或术后死亡率方面没有统计学上的显著差异。

讨论

目前已发表的文献中没有确凿证据表明围手术期静脉注射TXA会增加髋部骨折手术后血栓栓塞事件的风险。这项荟萃分析强化了TXA在减少髋部骨折手术后的术后输血和血红蛋白下降方面是有效的。本研究发现TXA不会增加非血栓栓塞并发症或术后死亡率。需要进一步进行以血栓栓塞并发症为主要结局的大规模研究,以明确确定TXA在髋部骨折手术中的安全性。

证据级别

I;随机对照试验的荟萃分析。

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