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预防性使用纤维蛋白原可减少全髋关节置换手术中的过度出血:一项随机双盲安慰剂对照试验。

Prophylactic Fibrinogen Reduces Excessive Bleeding in Total Hip Arthroplasty Surgery: A Randomized Double-blinded Placebo-controlled Trial.

作者信息

Shakeri Alireza, Abtahi Dariush, Shahmansouri Marjan, Manafi-Rasi Alireza

出版信息

Arch Bone Jt Surg. 2023;11(8):524-530. doi: 10.22038/ABJS.2023.69727.3274.

Abstract

OBJECTIVES

Excessive blood loss is a critical complication of total hip arthroplasty. We intended to determine whether preoperative fibrinogen administration reduces perioperative bleeding and the need for blood transfusion in total hip arthroplasty surgery.

METHODS

In 4 months, 178 patients who underwent total hip arthroplasty were randomly assigned equally to intervention and placebo-control groups in a double-blinded, parallel two-arm randomized controlled trial. Both intravenously, 30 min before the start of the surgery, the intervention group received two grams of fibrinogen concentrate dissolved in 100 ml of distilled water. In contrast, the control group received 100 ml of normal saline solution. The amount of postoperative blood loss served as the main result, and the requirement for blood transfusions served as the secondary outcome.

RESULTS

In comparison to the placebo, administering fibrinogen concentrate considerably reduced the amount of blood loss (P=0.001) and the requirement for blood transfusions (P=0.004). Patients who got fibrinogen concentrate experienced no side effects. In addition, patients in the fibrinogen group had significantly lower hemoglobin and higher fibrinogen levels in the recovery room and received lesser blood transfusions (P<0.005) than the placebo group.

CONCLUSION

In total hip arthroplasty, fibrinogen concentrate lessens postoperative bleeding and the requirement for blood transfusions.

摘要

目的

失血过多是全髋关节置换术的关键并发症。我们旨在确定术前给予纤维蛋白原是否能减少全髋关节置换术围手术期出血及输血需求。

方法

在4个月内,178例行全髋关节置换术的患者在一项双盲、平行双臂随机对照试验中被随机等分为干预组和安慰剂对照组。两组均在手术开始前30分钟静脉给药,干预组给予溶解于100毫升蒸馏水中的2克纤维蛋白原浓缩物,对照组则给予100毫升生理盐水溶液。术后失血量作为主要结果,输血需求作为次要结果。

结果

与安慰剂相比,给予纤维蛋白原浓缩物显著减少了失血量(P = 0.001)和输血需求(P = 0.004)。接受纤维蛋白原浓缩物的患者未出现副作用。此外,纤维蛋白原组患者在恢复室的血红蛋白水平显著较低,纤维蛋白原水平较高,且输血次数少于安慰剂组(P < 0.005)。

结论

在全髋关节置换术中,纤维蛋白原浓缩物可减少术后出血及输血需求。

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Current perspective on fibrinogen concentrate in critical bleeding.当前对严重出血中纤维蛋白原浓缩物的看法。
Expert Rev Clin Pharmacol. 2020 Jul;13(7):761-778. doi: 10.1080/17512433.2020.1776608. Epub 2020 Jul 17.

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