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机器人辅助根治性前列腺切除术开始时使用氨甲环酸的安全性和有效性:一项双盲前瞻性随机试点研究。

Safety and Efficacy of Using Tranexamic Acid at the Beginning of Robotic-Assisted Radical Prostatectomy in a Double-Blind Prospective Randomized Pilot Study.

机构信息

Department of Urology, Faculty of Medicine and University Hospital Hradec Králové, Czech Republic.

Department of Surgery, Faculty of Medicine and University Hospital Hradec Králové, Czech Republic.

出版信息

Acta Medica (Hradec Kralove). 2020;63(4):176-182. doi: 10.14712/18059694.2020.60.

Abstract

BACKGROUND

The prophylactic administration of tranexamic acid has been shown to be appropriate for procedures with a high risk of perioperative bleeding in cardiac surgery and orthopaedics. In urology the ambiguous results have been reported. Our goal was to evaluate the effect of tranexamic acid administration in robotic-assisted radical prostatectomy (RARP). A pilot, prospective, double-blind, randomized study was conducted to evaluate this effect.

METHODS

The study included 100 patients who received RARP in the period from April 2017 to January 2018. The patients were randomly assigned to study and control groups of 50 patients each.

RESULTS

The median follow-up was 6 months. Lower haemoglobin level drop weighted for gram of operated prostate was observed in the study group when treating the dorsal vein complex (DVC) at the beginning of the procedure (p = 0.004 after 3 hours and p < 0.001 after 24 hours). There was no evidence of any serious side effect of tranexamic acid.

CONCLUSION

We demonstrated the safety of tranexamic acid at RARP. In addition, we showed that administration of tranexamic acid at the beginning of RARP significantly reduces the decrease in haemoglobin after the procedure when treating the DVC at the beginning of the procedure.

摘要

背景

氨甲环酸预防性给药已被证明适用于心脏手术和骨科中围手术期出血风险较高的手术。在泌尿科,结果存在争议。我们的目的是评估氨甲环酸在机器人辅助根治性前列腺切除术(RARP)中的应用效果。为此,我们进行了一项前瞻性、双盲、随机的初步研究。

方法

该研究纳入了 2017 年 4 月至 2018 年 1 月期间接受 RARP 的 100 例患者。患者被随机分配至研究组和对照组,每组 50 例。

结果

中位随访时间为 6 个月。研究组在手术开始时处理背静脉复合体(DVC)时,每切除前列腺克血红蛋白下降幅度较低(术后 3 小时时,p = 0.004;术后 24 小时时,p < 0.001)。氨甲环酸无任何严重不良反应的证据。

结论

我们证明了 RARP 中氨甲环酸的安全性。此外,我们还表明,在手术开始时处理 DVC 时,RARP 开始时给予氨甲环酸可显著减少术后血红蛋白的下降。

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