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围手术期氨甲环酸输注治疗髋臼骨折固定的安全性和有效性:一项随机安慰剂对照双盲前瞻性研究。

Safety and efficacy of perioperative tranexamic acid infusion in acetabular fracture fixation: A randomized placebo-controlled double-blind prospective study.

机构信息

Institute of Orthopaedics, Max Hospital Mohali, Punjab, 160055, India.

Institute of Orthopaedics, Max Hospital Mohali, Punjab, 160055, India.

出版信息

Injury. 2022 Oct;53(10):3361-3364. doi: 10.1016/j.injury.2022.08.036. Epub 2022 Aug 18.

Abstract

INTRODUCTION

Open reduction and internal fixation of acetabular fracture is associated with significant blood loss. Although Tranexamic acid (TXA) infusion effectively reduces perioperative blood loss and transfusion requirements in elective orthopedic surgery, its efficacy in major orthopedic trauma surgery is controversial.

MATERIAL AND METHODS

Sixty-three patients undergoing open reduction and internal fixation of acetabular fracture were randomized into either TXA (n = 36) or placebo (n = 27) group. TXA group received a bolus dose of TXA (10 mg/kg) 15 min prior to incision, followed by another similar dose after 3 h of surgery. The placebo group received the same volume of normal saline similarly. All patients were operated on by a single pelviacetabular surgeon with a uniform perioperative protocol. The intraoperative blood loss, drain output, the number of blood transfusions, postoperative hemoglobin (Hb) drop, and hematocrit (Hct) drop were calculated.

RESULTS

Both groups were similar in relation to age, sex, BMI, preoperative Hb, the timing of surgery, fracture pattern, operative time, and surgical approaches. The mean postoperative Hb was 10.35 ± 1.36 gm% in TXA group and 9.74 ± 1.98 gm% in placebo group (p-value 0.158). There were no differences in intraoperative blood loss (438.11 ml vs. 442.81, p=.947), drain output (131.94 ml vs. 129.63, p=.870), and blood transfusion (8 patients vs. five patients, p=.719) between the groups. The drop in Hb and Hct in the postoperative period was also statistically not significant between the groups.

CONCLUSION

There is no significant reduction in blood loss and blood transfusion with the use of intravenous Tranexamic acid in open reduction and internal fixation of acetabular fractures.

摘要

介绍

髋臼骨折切开复位内固定术会导致大量失血。虽然氨甲环酸(TXA)输注在择期骨科手术中能有效减少围手术期失血和输血需求,但在大型骨科创伤手术中的疗效仍存在争议。

材料与方法

63 例行髋臼骨折切开复位内固定术的患者被随机分为 TXA 组(n=36)或安慰剂组(n=27)。TXA 组在切开前 15 分钟给予 TXA(10mg/kg)推注剂量,然后在手术后 3 小时再次给予相同剂量。安慰剂组给予相同体积的生理盐水。所有患者均由一位骨盆髋臼外科医生进行手术,采用相同的围手术期方案。计算术中失血量、引流量、输血次数、术后血红蛋白(Hb)下降量和红细胞压积(Hct)下降量。

结果

两组在年龄、性别、BMI、术前 Hb、手术时间、骨折类型、手术时间和手术入路方面相似。TXA 组的平均术后 Hb 为 10.35±1.36gm%,安慰剂组为 9.74±1.98gm%(p 值为 0.158)。两组术中失血量(438.11ml 比 442.81,p=0.947)、引流量(131.94ml 比 129.63,p=0.870)和输血(8 例比 5 例,p=0.719)均无差异。术后 Hb 和 Hct 的下降在两组间也无统计学差异。

结论

髋臼骨折切开复位内固定术中使用静脉注射氨甲环酸并不能显著减少失血量和输血。

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