Hemmati Ghavshough Mahdi, Shirinzadeh Zahra, Alizadeh Mansour, Sadri Mohammad, Farshid Saman
Urology Department, Rutgers Cancer Institute, New Brunswick, New Jersey, USA.
Epidemiology Department, School of Public Health of Tehran University, Tehran, Iran.
Adv Urol. 2025 Aug 4;2025:9294177. doi: 10.1155/aiu/9294177. eCollection 2025.
Benign prostatic hyperplasia (BPH) often necessitates surgical treatment, with open prostatectomy remaining a standard approach. However, this procedure carries a significant risk of intraoperative and postoperative bleeding, often requiring blood transfusions. Tranexamic acid (TXA), an antifibrinolytic agent, has shown potential in reducing surgical blood loss. This study aims to evaluate the effect of intraoperative local administration of TXA on perioperative blood loss in patients undergoing open prostatectomy for BPH. In this double-blind randomized controlled trial, 140 patients with BPH were assigned to either a TXA group or control group. In the intervention group, 1 g of TXA was diluted in 100 mL of normal saline and injected into the prostatic fossa during surgery, followed by three additional postoperative doses. The primary outcome was total perioperative blood loss. Secondary outcomes included changes in hemoglobin, hematocrit, platelet count, transfusion requirement, and length of hospital stay. Baseline differences, including a significant age gap between the groups (mean age: TXA group 60.70 ± 7.44 years vs. control group 70.50 ± 6.68 years), were statistically adjusted during analysis. Perioperative blood loss was significantly lower in the TXA group (116.65 ± 43.23 mL) compared to the control group (210.27 ± 87.94 mL, value = 0.001). The mean hemoglobin drop was also significantly reduced in the TXA group at both 24 and 48 h postoperatively. Fewer patients in the TXA group required blood transfusion (2.85%) compared to the control group (10%, value = 0.03). No major adverse events directly attributed to TXA were identified, although one patient in the TXA group developed a pulmonary embolism. Intraoperative local administration of TXA significantly reduces perioperative blood loss and the need for blood transfusion in patients undergoing open prostatectomy. TXA appears to be a safe and effective strategy for minimizing surgical bleeding in this setting. Iranian Registry of Clinical Trials: IRCT20180625040232N8.
良性前列腺增生（BPH）常常需要手术治疗，开放性前列腺切除术仍是一种标准术式。然而，该手术存在术中及术后出血的重大风险，常常需要输血。氨甲环酸（TXA），一种抗纤溶药物，已显示出在减少手术失血方面的潜力。本研究旨在评估术中局部应用TXA对接受开放性前列腺切除术治疗BPH患者围手术期失血的影响。在这项双盲随机对照试验中，140例BPH患者被分配至TXA组或对照组。在干预组中，1克TXA被稀释于100毫升生理盐水中，在手术期间注入前列腺窝，术后再追加三次剂量。主要结局是围手术期总失血量。次要结局包括血红蛋白、血细胞比容、血小板计数、输血需求及住院时间的变化。在分析过程中对基线差异进行了统计学调整，包括两组之间显著的年龄差距（平均年龄：TXA组60.70±7.44岁，对照组70.50±6.68岁）。与对照组（210.27±87.94毫升，P值=0.001）相比，TXA组围手术期失血量显著更低（116.65±43.23毫升）。术后24小时和48小时时，TXA组的平均血红蛋白下降也显著减少。与对照组（10%，P值=0.03）相比，TXA组需要输血的患者更少（2.85%）。尽管TXA组有1例患者发生肺栓塞，但未发现直接归因于TXA的重大不良事件。术中局部应用TXA可显著减少接受开放性前列腺切除术患者的围手术期失血量及输血需求。在这种情况下，TXA似乎是一种安全有效的减少手术出血的策略。伊朗临床试验注册中心：IRCT20180625040232N8。
