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研究脊柱手术中标准剂量氨甲环酸方案的安全性。

Examining the safety profile of a standard dose tranexamic acid regimen in spine surgery.

作者信息

Setliff Joshua, Dalton Jonathan, Sadhwani Shaan, Tang Melissa Yunting, Mirvish Asher, Adida Samuel, Wawrose Richard, Lee Joon Y, Fourman Mitchell S, Shaw Jeremy D

机构信息

1Department of Orthopaedic Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

3Pittsburgh Orthopaedic Spine Research Group, Pittsburgh, Pennsylvania.

出版信息

Neurosurg Focus. 2023 Oct;55(4):E16. doi: 10.3171/2023.7.FOCUS23384.

Abstract

OBJECTIVE

Perioperative blood loss during spinal surgery is associated with complications and in-hospital mortality. Weight-based administration of tranexamic acid (TXA) has the potential to reduce blood loss and related complications in spinal surgery; however, evidence for standardized dosing is lacking. The purpose of this study was to evaluate the impact of a standardized preoperative 2 g bolus TXA dosing regimen on perioperative transfusion, blood loss, thromboembolic events, and postoperative outcomes in spine surgery patients.

METHODS

An institutional review board approved this retrospective review of prospectively enrolled adult spine patients (> 18 years of age). Patients were included who underwent elective and emergency spine surgery between September 2018 and July 2021. Patients who received a standardized 2 g dose of TXA were compared to patients who did not receive TXA. The primary outcome measure was perioperative transfusion. Secondary outcomes included estimated blood loss and thromboembolic or other perioperative complications. Descriptive statistics were calculated, and continuous variables were analyzed with the two-tailed independent t-test, while categorical variables were analyzed with the Fisher's exact test or chi-square test. Stepwise multivariate regression analysis was performed to examine independent risk factors for perioperative outcomes.

RESULTS

TXA was administered to 353 of 453 (78%) patients, and there were no demographic differences between groups. Although the TXA group had more operative levels and a longer operative time, the transfusion rate was not different between the TXA and no-TXA groups (7.4% vs 8%, p = 0.83). Stepwise multivariate regression found that the number of operative levels was an independent predictor of perioperative transfusion and that both operative levels and operative time were correlated with estimated blood loss. TXA was not identified as an independent predictor of any postoperative complication.

CONCLUSIONS

A standardized preoperative 2 g bolus TXA dosing regimen was associated with an excellent safety profile, and despite increased case complexity in terms of number of operative levels and operative time, patients treated with TXA did not require more blood transfusions than patients not treated with TXA.

摘要

目的

脊柱手术围手术期失血与并发症及院内死亡率相关。基于体重给药的氨甲环酸(TXA)有可能减少脊柱手术中的失血及相关并发症;然而,缺乏标准化给药的证据。本研究的目的是评估标准化术前2克大剂量TXA给药方案对脊柱手术患者围手术期输血、失血、血栓栓塞事件及术后结局的影响。

方法

机构审查委员会批准了这项对前瞻性纳入的成年脊柱患者(>18岁)的回顾性研究。纳入2018年9月至2021年7月期间接受择期和急诊脊柱手术的患者。将接受标准化2克剂量TXA的患者与未接受TXA的患者进行比较。主要结局指标是围手术期输血。次要结局包括估计失血量以及血栓栓塞或其他围手术期并发症。计算描述性统计数据,连续变量采用双尾独立t检验进行分析,分类变量采用Fisher精确检验或卡方检验进行分析。进行逐步多因素回归分析以检查围手术期结局的独立危险因素。

结果

453例患者中有353例(78%)接受了TXA治疗,两组之间在人口统计学方面无差异。尽管TXA组的手术节段更多且手术时间更长,但TXA组和未使用TXA组的输血率并无差异(7.4%对8%,p = 0.83)。逐步多因素回归发现,手术节段数是围手术期输血的独立预测因素,并且手术节段数和手术时间均与估计失血量相关。未发现TXA是任何术后并发症的独立预测因素。

结论

标准化术前2克大剂量TXA给药方案具有良好的安全性,尽管在手术节段数和手术时间方面病例复杂性增加,但接受TXA治疗的患者并不比未接受TXA治疗的患者需要更多输血。

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