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氨甲环酸在初次肩关节置换术后减少输血、术后感染或血肿形成方面疗效的证据不确凿:一项采用试验序贯分析的荟萃分析

Inconclusive evidence for the efficacy of tranexamic acid in reducing transfusions, postoperative infection or hematoma formation after primary shoulder arthroplasty: A meta-analysis with trial sequential analysis.

作者信息

Rojas Jorge, Srikumaran Uma, McFarland Edward G

机构信息

Division of Shoulder Surgery, Department of Orthopaedic Surgery, The Johns Hopkins University, Baltimore, MD, USA.

Division of Shoulder and Elbow Surgery, Department of Orthopedics and Traumatology, Hospital Universitario Fundación Santa Fe de Bogotá, Bogota, Colombia.

出版信息

Shoulder Elbow. 2021 Feb;13(1):38-50. doi: 10.1177/1758573219896794. Epub 2020 Jan 13.

Abstract

BACKGROUND

Tranexamic acid efficacy on clinically relevant adverse outcomes in patients undergoing shoulder arthroplasty has been contradictory. The aim of this review was to analyze whether tranexamic acid administration could decrease transfusions, infection and hematoma formation in patients undergoing shoulder arthroplasty.

METHODS

PubMed, EMBASE, and the Cochrane Library were searched up to May 2019 for randomized controlled trials comparing tranexamic acid to placebo in shoulder arthroplasty. Random-effect models were performed to meta-analyze the evidence. Trial sequential analysis was used to calculate and to establish the conclusiveness of the evidence derived from the meta-analysis.

RESULTS

Four randomized controlled trials comprising 375 patients were included. Meta-analysis showed no effect of tranexamic acid on transfusion rate (RR = 0.48 (adjusted 95% CI 0.05 to 3.85)). The possible effect of tranexamic acid on hematoma formation or infection rates after shoulder arthroplasty is non-estimable with the current evidence. The sample size necessary to reliably determine if tranexamic acid decreases transfusions, infection rates and hematoma formation is not available from the current literature as determined by the trial sequential analysis.

DISCUSSION

While tranexamic acid has proven its efficacy in decreasing blood loss in shoulder arthroplasty, this meta-analysis of randomized controlled trials clarifies that there is currently no conclusive evidence for a positive effect of tranexamic acid upon transfusion rate, infection rates or hematoma formation in patients undergoing primary shoulder arthroplasty.

摘要

背景

氨甲环酸对接受肩关节置换术患者的临床相关不良结局的疗效存在矛盾。本综述的目的是分析氨甲环酸的使用是否能减少接受肩关节置换术患者的输血、感染和血肿形成。

方法

检索截至2019年5月的PubMed、EMBASE和Cochrane图书馆,查找在肩关节置换术中比较氨甲环酸与安慰剂的随机对照试验。采用随机效应模型对证据进行荟萃分析。试验序贯分析用于计算和确定荟萃分析证据的确定性。

结果

纳入了四项随机对照试验,共375例患者。荟萃分析显示氨甲环酸对输血率无影响(RR = 0.48(校正95%CI 0.05至3.85))。根据现有证据,无法估计氨甲环酸对肩关节置换术后血肿形成或感染率的可能影响。根据试验序贯分析,目前文献中没有可用于可靠确定氨甲环酸是否能降低输血、感染率和血肿形成所需的样本量。

讨论

虽然氨甲环酸已证明其在减少肩关节置换术中失血方面的疗效,但这项随机对照试验的荟萃分析表明,目前尚无确凿证据表明氨甲环酸对接受初次肩关节置换术患者的输血率、感染率或血肿形成有积极影响。

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Risk factors associated with blood transfusion after shoulder arthroplasty.肩关节置换术后输血相关的危险因素。
JSES Open Access. 2017 May 19;1(1):10-14. doi: 10.1016/j.jses.2017.03.004. eCollection 2017 Mar.

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