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[静脉注射氨甲环酸在泌尿外科内镜经尿道切除术中的安全性和有效性:前瞻性随机试验]

[Safety and efficacy of intravenous tranexamic acid in endoscopic transurethral resections in urology: Prospective randomized trial].

作者信息

Jendoubi A, Malouch A, Bouzouita A, Riahi Y, Necib H, Ghedira S, Houissa M

机构信息

Department of anaesthesia and intensive care, faculty of medicine of Tunis, Charles-Nicolle hospital of Tunis, university of Tunis El Manar, Tunis, Tunisie.

Department of urology, faculty of medicine of Tunis, Charles-Nicolle hospital of Tunis, university of Tunis El Manar, Tunis, Tunisie.

出版信息

Prog Urol. 2017 Dec;27(16):1036-1042. doi: 10.1016/j.purol.2017.09.008. Epub 2017 Oct 23.

Abstract

BACKGROUND

Endoscopic urological procedures (transurethral resection of the prostate TURP/transurethral resection of bladder tumor TURBT) are not without risk of significant bleeding. This risk is due to the vascular nature of the tissues and their high levels of fibrinolytic enzymes in the tissues and urine. This study was conducted to evaluate the safety and efficacy of the antifibrinolytic agent tranexamic acid (TXA) in reducing blood loss in patients undergoing TURP/TURBT and transfusion requirement.

METHODS

This study was a prospective, randomized, double-blind, placebo controlled clinical trial. One hundred and thirty-one patients of ASA physical status I or II, undergoing TURP (60 patients) or TURBT (71 patients) were randomly allocated to receive IV TXA: bolus of 10mg/kg at the induction of anesthesia followed by infusion of 1mg/kg/h intraoperatively and for 24h postoperatively or an equal volume of saline (control group). Blood loss was evaluated in terms of reduction in the serum hemoglobin level (delta Hb=Hb H24-Hb H0).

RESULTS

There was no difference between two groups in terms of transfusion requirements and episodes of retention. TXA did not significantly reduce mean blood loss compared with placebo during TURP (1.37±0.69 vs. 1.72±1.23g/dL respectively, P=0.256) or TURBT (1.15±0.95 vs. 1.07±0.88g/dL; P=0.532). No thrombotic complications were noted in any patient.

CONCLUSION

Tranexamic acid did not reduce transfusion requirements or perioperative blood loss in transurethral resection of the prostate or bladder tumor.

LEVEL OF EVIDENCE

摘要

背景

泌尿外科内镜手术(经尿道前列腺切除术TURP/经尿道膀胱肿瘤切除术TURBT)并非没有严重出血风险。这种风险归因于组织的血管特性以及组织和尿液中高水平的纤维蛋白溶解酶。本研究旨在评估抗纤维蛋白溶解剂氨甲环酸(TXA)在减少接受TURP/TURBT患者的失血及输血需求方面的安全性和有效性。

方法

本研究为一项前瞻性、随机、双盲、安慰剂对照临床试验。131例美国麻醉医师协会(ASA)身体状况为I或II级、接受TURP(60例)或TURBT(71例)的患者被随机分配接受静脉注射TXA:麻醉诱导时静脉推注10mg/kg,随后术中及术后24小时以1mg/kg/h的速度输注,或等量生理盐水(对照组)。根据血清血红蛋白水平的降低情况(ΔHb = Hb H24 - Hb H0)评估失血量。

结果

两组在输血需求和尿潴留发生率方面无差异。与安慰剂相比,TXA在TURP期间(分别为1.37±0.69 vs. 1.72±1.23g/dL,P = 0.256)或TURBT期间(1.15±0.95 vs. 1.07±0.88g/dL;P = 0.532)均未显著减少平均失血量。未在任何患者中观察到血栓形成并发症。

结论

氨甲环酸未减少经尿道前列腺或膀胱肿瘤切除术中的输血需求或围手术期失血量。

证据级别

4级。

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