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氨甲环酸与安慰剂对烧伤患者手术清创后止血效果的比较疗效:一项随机对照临床试验。

Comparative efficacy of tranexamic acid versus placebo on hemostatic outcomes after the surgical debridement of burn patients: A randomized controlled clinical trial.

作者信息

Castillo-Cardiel Guadalupe, Avalos-López Marisol, Méndez-Miranda Carlos, Gil-Vigna Javier Alejandro, Fuentes-Orozco Clotilde, Cervantes-Guevara Gabino, Cervantes-Pérez Enrique, Ramírez-Ochoa Sol, Álvarez-Villaseñor Andrea Socorro, Cortés-Flores Ana Olivia, Morfín-Meza Kathia Dayana, García Andrea, Vázquez-Sánchez Sergio Jiram, González-Ojeda Alejandro

机构信息

Department of Maxillofacial Plastic and Reconstructive Surgery, Specialties Hospital, Western Medical Center, Mexican Institute of Social Security and Universidad de Guadalajara. Guadalajara, Jalisco, Mexico.

Biomedical Research Unit 02, Specialties Hospital, Western Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico.

出版信息

Burns. 2025 Mar;51(2):107339. doi: 10.1016/j.burns.2024.107339. Epub 2024 Nov 30.

Abstract

INTRODUCTION

Burns are traumatic events that can affect multiple systems beyond the skin. The rapid removal of the burn eschar is a key step in the effective treatment of severe burns, and surgical debridement is currently the standard of care for eschar removal in burn patients. However, surgical debridement is highly hemorrhagic. Tranexamic acid, an antifibrinolytic lysine analog, may reduce bleeding.

METHODS

A randomized control trial was conducted to examine the effects of preoperative tranexamic acid administration in the early surgical debridement of severe burns. The study was conducted from January to December 2022.

RESULTS

The general characteristics of patients and mechanism of injury were similar between the treated and control groups. The burned body surface area was 26.46 % ± 5.45 % in the study group and 27.10 % ± 4.45 % in the control group (p = 0.83). Intraoperative hemorrhage volume was larger in the control group (299.3 ± 88.9 ml) than in the study group (117 ± 51.7 ml) (p = 0.0001). The decreases in hemoglobin and hematocrit levels were larger in the control group (2.1 ± 1.4 g/dl and 5.7 % ± 4.6 %) than in the study group (0.85 ± 0.4 g/dl and 2.1 % ± 0.5 %) (p = 0.004 and 0.01, respectively). Six patients in the control group but no patients in the study group required blood transfusion (p = 0.002). No thromboembolic events were observed.

CONCLUSION

These findings suggest that tranexamic acid was effective at reducing intraoperative hemorrhage volume and the need for transfusion in burn surgery patients. It was shown to be safe for use in these patients.

摘要

引言

烧伤是一种创伤性事件,可影响皮肤以外的多个系统。快速去除烧伤焦痂是有效治疗重度烧伤的关键步骤,手术清创是目前烧伤患者去除焦痂的护理标准。然而,手术清创出血量大。氨甲环酸,一种抗纤维蛋白溶解赖氨酸类似物,可能会减少出血。

方法

进行了一项随机对照试验,以研究术前给予氨甲环酸在重度烧伤早期手术清创中的效果。该研究于2022年1月至12月进行。

结果

治疗组和对照组患者的一般特征及损伤机制相似。研究组烧伤体表面积为26.46%±5.45%,对照组为27.10%±4.45%(p = 0.83)。对照组术中出血量(299.3±88.9 ml)大于研究组(117±51.7 ml)(p = 0.0001)。对照组血红蛋白和血细胞比容水平的下降幅度(分别为2.1±1.4 g/dl和5.7%±4.6%)大于研究组(分别为0.85±0.4 g/dl和2.1%±0.5%)(p分别为0.004和0.01)。对照组有6例患者需要输血,而研究组无患者需要输血(p = 0.002)。未观察到血栓栓塞事件。

结论

这些发现表明,氨甲环酸在减少烧伤手术患者术中出血量和输血需求方面是有效的。在这些患者中使用显示是安全的。

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