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经尿道前列腺单极切除术时前列腺内注射氨甲环酸减少出血:一项随机对照临床试验。

Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar Transurethral Resection of the Prostate: A Randomized Controlled Clinical Trial.

机构信息

Urology Department, Faculty of Medicine, Benha University, Benha, Egypt.

Urology Department, Faculty of Medicine, Benha University, Benha, Egypt.

出版信息

Urology. 2024 Sep;191:119-126. doi: 10.1016/j.urology.2024.05.015. Epub 2024 May 22.

Abstract

OBJECTIVE

To assess the role of intraprostatic injection of tranexamic acid (TXA) in reducing blood loss during transurethral resection of the prostate (TURP).

METHODS

We conducted a randomized, controlled, double-blind trial involving 60 patients with benign prostatic hyperplasia aged 50-85years, undergoing monopolar TURP. Patients' prostatic weights ranged from 50 to 80 g. They were divided equally into two groups: group I received an intraprostatic injection of 1 g of TXA (Cyklokapron) dissolved in 50 mL of 0.9 % saline at multiple sites, while group II (control) received a 60 mL saline injection. Comprehensive clinical assessments and standard laboratory tests, including screenings for TXA hypersensitivity, were performed for all patients.

RESULTS

Group I exhibited significantly lower intraoperative blood loss and hemoglobin concentration in irrigation fluid immediately postsurgery and at the 6-hour postoperative mark compared to group II (P < .05). Coagulation parameters-activated partial thromboplastin time, prothrombin time, fibrinogen level, and thrombin clotting time-showed no significant differences between the groups preoperatively or at 6 and 24 hours postoperatively. No thromboembolic events or other complications were reported in either group.

CONCLUSION

The intraprostatic injection of TXA during monopolar TURP is safe, with minimal adverse effects, and effectively reduces blood loss.

REGISTRATION

The study was registered on ClinicalTrials.gov No (ID: NCT05913466).

摘要

目的

评估经尿道前列腺切除术(TURP)中前列腺内注射氨甲环酸(TXA)减少出血的作用。

方法

我们进行了一项随机、对照、双盲试验,纳入了 60 名年龄在 50-85 岁、接受单极 TURP 的良性前列腺增生患者。患者前列腺重量为 50-80g,平均分为两组:组 I 接受 1g 氨甲环酸(Cyklokapron)溶于 50ml 0.9%生理盐水在多个部位的前列腺内注射,组 II(对照组)接受 60ml 生理盐水注射。所有患者均进行了综合临床评估和标准实验室检查,包括对 TXA 过敏的筛查。

结果

与组 II 相比,组 I 在手术期间的出血量和术后立即及 6 小时时的灌洗液中血红蛋白浓度明显较低(P<0.05)。凝血参数-活化部分凝血活酶时间、凝血酶原时间、纤维蛋白原水平和凝血酶凝固时间-在术前或术后 6 小时和 24 小时两组之间无显著差异。两组均未报告血栓栓塞事件或其他并发症。

结论

在单极 TURP 中前列腺内注射 TXA 是安全的,副作用极小,并能有效减少出血。

注册

该研究在 ClinicalTrials.gov 上注册(编号:NCT05913466)。

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