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经皮椎间孔镜腰椎间融合术后多次序贯应用氨甲环酸对术后失血的影响:一项前瞻性随机对照试验。

The effect of perioperative sequential application of multiple doses of tranexamic acid on postoperative blood loss after PLIF: a prospective randomized controlled trial.

机构信息

Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Orthopedic Laboratory of Chongqing Medical University.

Department of Orthopedics Surgery, University-Town Hospital of Chongqing Medical University, Chongqing, People's Republic of China.

出版信息

Int J Surg. 2024 Apr 1;110(4):2122-2133. doi: 10.1097/JS9.0000000000001083.

DOI:10.1097/JS9.0000000000001083
PMID:38215261
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11020010/
Abstract

BACKGROUND

Tranexamic acid (TXA) has been utilized in spinal surgery to effectively reduce intraoperative blood loss (IBL) and allogeneic blood transfusion rates. However, the traditional TXA regimen might last the entire duration of hyperfibrinolysis caused by surgical trauma, resulting in its limited ability to reduce postoperative blood loss (PBL). Therefore, the aim of this study was to investigate the effectiveness of perioperative sequential administration of multiple doses of TXA in reducing PBL in patients who underwent posterior lumbar interbody fusion (PLIF).

METHODS

From October 2022 to June 2023, 231 patients who were diagnosed with lumbar degenerative disease and scheduled to undergo PLIF were prospectively enrolled in the present study. The patients were randomly divided into three groups. Moreover, all patients received an intravenous injection of TXA at a dose of 15 mg/kg 15 min before the surgical skin incision. Patients in Group A received a placebo of normal saline after surgery, while patients in Group B received three additional intravenous injections of TXA at a dose of 15 mg/kg every 24 h. Patients in Group C received three additional intravenous injections of TXA at a dose of 15 mg/kg every 5 h. The primary outcome measure was PBL. In addition, this study assessed total blood loss (TBL), IBL, routine blood parameters, liver and kidney function, coagulation parameters, fibrinolysis indexes, inflammatory indicators, drainage tube removal time (DRT), length of hospital stay (LOS), blood transfusion rate, and incidence of complications for all subjects.

RESULTS

The PBL, TBL, DRT, and LOS of Group B and Group C were significantly lower than those of Group A ( P <0.05). The level of D-dimer (D-D) in Group C was significantly lower than that in Group A on the first day after the operation ( P =0.002), and that in Group B was significantly lower than that in Group A on the third day after the operation ( P =0.003). The interleukin-6 levels between the three groups from 1 to 5 days after the operation were in the order of Group A > Group B > Group C. No serious complications were observed in any patient. The results of multiple stepwise linear regression analysis revealed that PBL was positively correlated with incision length, IBL, smoking history, history of hypertension, preoperative fibrinogen degradation product level, and blood transfusion. It was negatively correlated with preoperative levels of fibrinogen, red blood cells, blood urea nitrogen, and age. Compared to female patients, male patients had an increased risk of PBL. Finally, the incidence of PBL was predicted.

CONCLUSIONS

Sequential application of multiple doses of TXA during the perioperative period could safely and effectively reduce PBL and TBL, shorten DRT and LOS, reduce postoperative D-D generation, and reduce the postoperative inflammatory response. In addition, this study provided a novel prediction model for PBL in patients undergoing PLIF.

摘要

背景

氨甲环酸(TXA)已在脊柱手术中被用于有效减少术中失血量(IBL)和异体输血率。然而,传统的 TXA 方案可能持续整个手术创伤引起的纤溶亢进期,导致其减少术后失血量(PBL)的能力有限。因此,本研究旨在探讨围手术期多次给予 TXA 对接受后路腰椎间融合术(PLIF)的患者减少 PBL 的有效性。

方法

2022 年 10 月至 2023 年 6 月,前瞻性纳入 231 例诊断为腰椎退行性疾病并计划接受 PLIF 的患者。将患者随机分为三组。此外,所有患者在手术皮肤切口前 15 分钟均接受 15mg/kg 的静脉注射 TXA。A 组患者术后给予生理盐水安慰剂,B 组患者术后每 24 小时给予 3 次 15mg/kg 的静脉注射 TXA,C 组患者术后每 5 小时给予 3 次 15mg/kg 的静脉注射 TXA。主要结局指标为 PBL。此外,本研究还评估了所有患者的总失血量(TBL)、IBL、常规血液参数、肝肾功能、凝血参数、纤溶指标、炎症指标、引流管拔除时间(DRT)、住院时间(LOS)、输血率和并发症发生率。

结果

B 组和 C 组的 PBL、TBL、DRT 和 LOS 均明显低于 A 组(P<0.05)。C 组术后第 1 天 D-二聚体(D-D)水平明显低于 A 组(P=0.002),B 组术后第 3 天明显低于 A 组(P=0.003)。三组术后 1-5 天的白细胞介素-6 水平依次为 A 组>B 组>C 组。任何患者均未观察到严重并发症。多元逐步线性回归分析结果显示,PBL 与切口长度、IBL、吸烟史、高血压史、术前纤维蛋白原降解产物水平和输血呈正相关,与术前纤维蛋白原、红细胞、血尿素氮和年龄呈负相关。与女性患者相比,男性患者 PBL 风险增加。最后,预测了 PBL 的发生率。

结论

围手术期多次应用 TXA 可安全有效地减少 PBL 和 TBL,缩短 DRT 和 LOS,减少术后 D-D 的产生,减轻术后炎症反应。此外,本研究为 PLIF 患者的 PBL 提供了一种新的预测模型。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa14/11020010/50047c03e78c/js9-110-2122-g006.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa14/11020010/50047c03e78c/js9-110-2122-g006.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa14/11020010/a4b049380634/js9-110-2122-g002.jpg
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