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氨甲环酸在骨盆髋臼创伤手术中的安全性和有效性:随机对照试验的系统评价和荟萃分析

Safety and efficacy of tranexamic acid in pelvi-acetabular trauma surgery: a systematic review and meta-analysis of randomized controlled trials.

作者信息

Triapthy Sujit Kumar, Khan Shahnawaz, Varghese Paulson, Patel Hursch, Mishra Nitasha, Jain Mantu

机构信息

All India Institute of Medical Sciences Bhubaneswar, Bhubaneswar, India.

OhioHealth, Columbus, United States.

出版信息

Eur J Orthop Surg Traumatol. 2025 Sep 10;35(1):387. doi: 10.1007/s00590-025-04506-y.

Abstract

BACKGROUND

Pelvic and acetabular fractures, often resulting from high-impact trauma, pose significant challenges due to extensive blood loss and complex surgical procedures. Tranexamic acid (TXA), widely used in elective orthopedic surgeries, offers a potential strategy for managing blood loss. However, its efficacy and safety in pelvic-acetabular trauma surgeries have shown inconsistent results in prior studies.

OBJECTIVE

To systematically evaluate the safety and efficacy of intravenous TXA in reducing perioperative blood loss, transfusion requirements, and complications in pelvic and acetabular trauma surgeries.

METHODS

A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted following PRISMA guidelines. Literature searches of PubMed, Embase, and Cochrane databases identified relevant studies. Data on blood loss, transfusion rates, thromboembolic events, surgical time, and complications were extracted and analyzed using RevMan 5.4 software. A random-effects model was applied to account for heterogeneity.

RESULTS

After screening, a total of 6 RCTs with 511 patients were included in this meta-analysis. TXA did not significantly reduce estimated blood loss (mean difference: 117.54 ml; 95% CI - 286.48-51.40; p = 0.17) or transfusion rates (risk ratio: 0.88; 95% CI 0.48-1.60; p = 0.67). No significant differences were observed in the number of transfused blood units, surgical duration, or complication rates, including thromboembolic events (risk ratio: 1.36; 95% CI 0.57-3.22; p = 0.48). TXA demonstrated a favorable safety profile with no increased risk of systemic or local complications.

CONCLUSION

While TXA appears safe in pelvi-acetabular trauma surgery, current evidence from six RCTs does not support a significant reduction in blood loss or transfusion needs. Further high-quality RCTs with standardized protocols are needed to refine TXA's role in this context.

摘要

背景

骨盆和髋臼骨折通常由高能量创伤导致,因大量失血和复杂的外科手术而带来重大挑战。氨甲环酸(TXA)在择期骨科手术中广泛应用,为控制失血提供了一种潜在策略。然而,其在骨盆 - 髋臼创伤手术中的疗效和安全性在既往研究中结果并不一致。

目的

系统评价静脉注射TXA在减少骨盆和髋臼创伤手术围手术期失血、输血需求及并发症方面的安全性和疗效。

方法

按照PRISMA指南进行随机对照试验(RCT)的系统评价和荟萃分析。通过检索PubMed、Embase和Cochrane数据库查找相关研究。使用RevMan 5.4软件提取并分析失血、输血率、血栓栓塞事件、手术时间和并发症的数据。采用随机效应模型处理异质性。

结果

筛选后,本荟萃分析共纳入6项RCT,涉及511例患者。TXA未显著减少估计失血量(平均差异:117.54 ml;95%CI -286.48 - 51.40;p = 0.17)或输血率(风险比:0.88;95%CI 0.48 - 1.60;p = 0.67)。在输血量、手术时长或并发症发生率(包括血栓栓塞事件,风险比:1.36;95%CI 0.57 - 3.22;p = 0.48)方面未观察到显著差异。TXA显示出良好的安全性,未增加全身或局部并发症风险。

结论

虽然TXA在骨盆 - 髋臼创伤手术中似乎安全,但目前来自6项RCT的证据不支持显著减少失血量或输血需求。需要进一步开展具有标准化方案的高质量RCT,以明确TXA在此情况下的作用。

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