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外用氨甲环酸在老年髋部骨折手术治疗中的疗效与安全性:随机对照试验的Meta分析

Efficacy and Safety of Topical Tranexamic Acid in Elderly Hip Fractures Undergoing Surgical Treatment: Meta-Analysis of Randomized Controlled Trials.

作者信息

Artykbay Sanzhar, Susantitaphong Paweena, Tantavisut Saran

机构信息

Department of Orthopaedics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

Division of Nephrology, Department of Medicine, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, The Thai Red Cross Society, Bangkok, Thailand.

出版信息

Clin Orthop Surg. 2025 Feb;17(1):16-28. doi: 10.4055/cios24184. Epub 2025 Jan 14.

Abstract

BACKGROUND

Hip fractures are a major health concern, especially among older adults. The conventional treatment for this condition involves surgery, but it carries the risk of excessive blood loss and complications. Tranexamic acid (TXA) has emerged as a possible solution for reducing bleeding during surgery. This study aims to evaluate the safety and efficacy of topical TXA compared to systemic TXA and a placebo in adult patients undergoing surgical treatment for hip fractures.

METHODS

The literature was reviewed using 3 databases (PubMed, Scopus, and Google Scholar) for studies published up to November 2023. All randomized controlled trials (RCTs) assessing the effectiveness of topical TXA in hip fracture surgery were included for analysis. Two reviewers assessed the quality of studies independently using the Cochrane-recommended risk-of-bias tool. Statistical analysis was performed on Comprehensive Meta-Analysis Software (version 2.0).

RESULTS

Nine RCTs with 1,024 patients assessed topical TXA in hip fracture surgery. Topical TXA significantly reduced hemoglobin loss (mean difference [MD], 1.004 g/dL; 95% CI, 0.096-1.911; = 0.03) and transfused blood units (relative risk, 0.640; 95% CI, 0.487-0.841; = 0.001) versus placebo, but there was no significant difference in hematocrit loss, total blood loss, deep vein thrombosis (DVT) rates, mortality, hospital stays, or surgery duration compared to placebo. Moreover, the meta-analysis revealed no significant differences between local and intravenous TXA administration in blood transfusion rates, total blood loss, incidence of DVT, and surgery duration. The results of the subgroup analysis that compared topical TXA to placebo in the arthroplasty group showed that TXA significantly reduced hemoglobin drop (MD, 1.500 g/dL; 95% CI, 0.324-2.676; = 0.012) and total blood loss (MD, -322.3 mL; 95% CI, -566.6 to -78.0; = 0.010).

CONCLUSIONS

The available evidence suggests that local TXA can significantly reduce hemoglobin loss and the number of transfused blood units without the risk of DVT compared to a placebo. Furthermore, local TXA demonstrated comparable effectiveness and safety to intravenous TXA following hip fracture surgery. Subgroup analysis revealed that topical TXA significantly decreased the hemoglobin drop and total blood loss in the arthroplasty group, as compared to the placebo.

摘要

背景

髋部骨折是一个重大的健康问题,在老年人中尤为突出。这种病症的传统治疗方法是手术,但手术存在失血过多和并发症的风险。氨甲环酸(TXA)已成为一种可能减少手术中出血的解决方案。本研究旨在评估局部应用TXA与全身应用TXA及安慰剂相比,在接受髋部骨折手术治疗的成年患者中的安全性和有效性。

方法

使用3个数据库(PubMed、Scopus和谷歌学术)检索截至2023年11月发表的研究文献。纳入所有评估局部应用TXA在髋部骨折手术中有效性的随机对照试验(RCT)进行分析。两名研究者使用Cochrane推荐的偏倚风险工具独立评估研究质量。在综合荟萃分析软件(2.0版)上进行统计分析。

结果

9项RCT共1024例患者评估了局部应用TXA在髋部骨折手术中的效果。与安慰剂相比,局部应用TXA显著减少了血红蛋白损失(平均差值[MD],1.004 g/dL;95%置信区间,0.096 - 1.911;P = 0.03)和输血单位数(相对风险,0.640;95%置信区间,0.487 - 0.841;P = 0.001),但与安慰剂相比,在血细胞比容损失、总失血量、深静脉血栓形成(DVT)发生率、死亡率、住院时间或手术时长方面无显著差异。此外,荟萃分析显示局部和静脉应用TXA在输血率、总失血量、DVT发生率和手术时长方面无显著差异。在关节置换组中,将局部应用TXA与安慰剂进行比较的亚组分析结果显示,TXA显著减少了血红蛋白下降(MD,1.500 g/dL;95%置信区间,0.324 - 2.676;P = 0.012)和总失血量(MD, - 322.3 mL;95%置信区间, - 566.6至 - 78.0;P = 0.010)。

结论

现有证据表明,与安慰剂相比,局部应用TXA可显著减少血红蛋白损失和输血单位数,且无DVT风险。此外,髋部骨折手术后,局部应用TXA与静脉应用TXA的有效性和安全性相当。亚组分析显示,与安慰剂相比,局部应用TXA在关节置换组中显著降低了血红蛋白下降和总失血量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/32c4/11791490/b1c1b52dc694/cios-17-16-g001.jpg

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