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氨甲环酸对老年股骨转子间骨折髓内固定手术患者减少失血的疗效及安全性:一项随机对照试验的荟萃分析

Efficacy and safety of tranexamic acid for reducing blood loss in elderly patients with intertrochanteric fracture treated with intramedullary fixation surgery: A meta-analysis of randomized controlled trials.

作者信息

Luo Xiangping, Huang Hangqing, Tang Xiong

机构信息

Department of Orthopaedics, Hengyang Central Hospital, Hunan, China.

出版信息

Acta Orthop Traumatol Turc. 2020 Jan;54(1):4-14. doi: 10.5152/j.aott.2020.01.88.

Abstract

OBJECTIVE

The aim of this study was to evaluate the efficacy and safety of tranexamic acid (TXA) in elderly patients with intertrochanteric fracture undergoing intramedullary fixation surgery.

METHODS

We searched MEDLINE, the Cochrane Library and EMBASE for published randomized clinical trials relevant to use of TXA in elderly patients with intertrochanteric fracture treated with intramedullary fixation surgery. Meta-analysis was performed according to the guidelines of the Cochrane Reviewer's Hand book.

RESULTS

Five trials assessing 540 patients were included for meta-analysis. The pooled results showed that the mean total blood loss in TXA group was significant lower than that in the control group (mean difference - 172.83, 95% CI -241.43 to -104.23; p<0.00001, fixed-effect model). The intra- and postoperative transfusion rate for the TXA group was 34.4% (91/264) and for the control group was 49.27% (136/276), and the relative risk was 0.71 (95% CI 0.52 to 0.97; p<0.03, random-effect model) with substantial heterogeneity (I2=63%, p=0.03). The overall incidence of thrombotic events was 6.43% (17/264) in the intravenous TXA group, 7.63% (21/275) in the control group, with no significant difference (relative risk 0.84, 95% CI 0.46 to 1.54; p=0.57, fixed-effect model).

CONCLUSION

The present evidence shows that TXA can significantly reduce total and hidden blood loss, transfusion rate, and do not increase the risk of thrombotic events in elderly patients with intertrochanteric fracture undergoing intramedullary fixation surgery. However, the impact of TXA on thrombotic events needs to be researched in more high-quality, large-sample randomized clinical trials.

LEVEL OF EVIDENCE

Level I Therapeutic Study.

摘要

目的

本研究旨在评估氨甲环酸(TXA)在接受髓内固定手术的老年转子间骨折患者中的疗效和安全性。

方法

我们检索了MEDLINE、Cochrane图书馆和EMBASE,以查找与TXA在接受髓内固定手术治疗的老年转子间骨折患者中的应用相关的已发表随机临床试验。根据Cochrane系统评价员手册的指南进行荟萃分析。

结果

纳入5项评估540例患者的试验进行荟萃分析。汇总结果显示,TXA组的平均总失血量显著低于对照组(平均差值-172.83,95%可信区间-241.43至-104.23;p<0.00001,固定效应模型)。TXA组的术中和术后输血率为34.4%(91/264),对照组为49.27%(136/276),相对风险为0.71(95%可信区间0.52至0.97;p<0.03,随机效应模型),存在显著异质性(I2=63%,p=0.03)。静脉注射TXA组血栓事件的总发生率为6.43%(17/264),对照组为7.63%(21/275),差异无统计学意义(相对风险0.84,95%可信区间0.46至1.54;p=0.57,固定效应模型)。

结论

目前的证据表明,TXA可显著减少老年转子间骨折患者接受髓内固定手术时的总失血量和隐性失血量、输血率,且不会增加血栓事件的风险。然而,TXA对血栓事件的影响需要在更多高质量、大样本的随机临床试验中进行研究。

证据水平

I级治疗性研究。

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