加拿大麦克马斯特大学Gordon Guyatt团队研究了氨甲环酸用于因癌症肝脏切除手术的患者是否可减少出血和输血。2024年8月19日出版的《美国医学会杂志》发表了这项成果。

在许多类型的手术中，氨甲环酸可以减少出血和输血，但其对因癌症相关适应症而接受肝脏切除手术患者的影响尚不清楚。

为了探讨氨甲环酸是否能减少肝切除术后7天内的红细胞输注，2014年12月1日至2022年11月8日，研究组在加拿大的10个肝胆胰科机构和美国的1个机构进行了氨甲环酸与安慰剂的多中心随机临床试验，随访90天。

参与者、临床医生和数据收集者对分配双盲。1384名因癌症相关适应症接受肝切除手术的患者志愿者样本符合资格标准并同意随机分组。参与者分别接受氨甲环酸（1g推注，然后在8小时内输注1g；n=619）或匹配的安慰剂（n=626），从麻醉诱导开始。主要结局是在手术后7天内接受红细胞输注。

主要分析包括1245名参与者（平均年龄63.2岁；39.8%为女性；56.1%诊断为结直肠肝转移）。两组的围手术期特征相似。在氨甲环酸组和安慰剂组中，分别有16.3%（n=101）和14.5%（n=91）的参与者输注了红细胞（比值比，1.15[95%CI，0.84-1.56]；P=0.38；绝对差异，2%[95%CI，-2%至6%]）。

两组之间的术中出血量测量值（氨甲环酸，817.3 mL；安慰剂，836.7 mL；P=0.75）和7天内的总估计出血量（氨甲环酸，1504.0 mL；安慰剂：1551.2 mL；P=0.38）相似。与安慰剂组相比，接受氨甲环酸治疗的参与者出现的并发症明显更多（比值比，1.28[95%CI，1.02-1.60]；P=0.03），静脉血栓栓塞症没有显著差异（比值比：1.68[95%CI,0.95-3.07]；P=0.08）。

研究结果表明，在因癌症相关适应症而接受肝切除术的患者中，氨甲环酸并没有减少出血或输血，但增加了围手术期并发症。

附：英文原文

Title: Tranexamic Acid in Patients Undergoing Liver Resection: The HeLiX Randomized Clinical Trial

Author: Paul J. Karanicolas, Yulia Lin, Stuart A. McCluskey, Jordan Tarshis, Kevin E. Thorpe, Alice Wei, Elijah Dixon, Geoff Porter, Prosanto Chaudhury, Sulaiman Nanji, Leyo Ruo, Melanie E. Tsang, Anton Skaro, Gareth Eeson, Sean Cleary, Carol-Anne Moulton, Chad G. Ball, Julie Hallet, Natalie Coburn, Pablo E. Serrano, Shiva Jayaraman, Calvin Law, Ved Tandan, Gonzalo Sapisochin, David Nagorney, Douglas Quan, Rory Smoot, Steven Gallinger, Peter Metrakos, Trevor W. Reichman, Diederick Jalink, Sean Bennett, Francis Sutherland, Edward Solano, Michele Molinari, Ephraim S. Tang, Susanne G. Warner, Oliver F. Bathe, Jeffrey Barkun, Michael L. Kendrick, Mark Truty, Rachel Roke, Grace Xu, Myriam Lafreniere-Roula, Gordon Guyatt, HPB CONCEPT Team

Issue&Volume: 2024-08-19

Abstract:

Importance  Tranexamic acid reduces bleeding and blood transfusion in many types of surgery, but its effect in patients undergoing liver resection for a cancer-related indication remains unclear.

Objective  To determine whether tranexamic acid reduces red blood cell transfusion within 7 days of liver resection.

Design, Setting, and Participants  Multicenter randomized clinical trial of tranexamic acid vs placebo conducted from December 1, 2014, to November 8, 2022, at 10 hepatopancreaticobiliary sites in Canada and 1 site in the United States, with 90-day follow-up. Participants, clinicians, and data collectors were blinded to allocation. A volunteer sample of 1384 patients undergoing liver resection for a cancer-related indication met eligibility criteria and consented to randomization.

Interventions  Tranexamic acid (1-g bolus followed by 1-g infusion over 8 hours; n=619) or matching placebo (n=626) beginning at induction of anesthesia.

Main Outcomes and Measures  The primary outcome was receipt of red blood cell transfusion within 7 days of surgery.

Results  The primary analysis included 1245 participants (mean age, 63.2 years; 39.8% female; 56.1% with a diagnosis of colorectal liver metastases). Perioperative characteristics were similar between groups. Red blood cell transfusion occurred in 16.3% of participants (n=101) in the tranexamic acid group and 14.5% (n=91) in the placebo group (odds ratio, 1.15 [95% CI, 0.84-1.56]; P=.38; absolute difference, 2% [95% CI, 2% to 6%]). Measured intraoperative blood loss (tranexamic acid, 817.3 mL; placebo, 836.7 mL; P=.75) and total estimated blood loss over 7 days (tranexamic acid, 1504.0 mL; placebo, 1551.2 mL; P=.38) were similar between groups. Participants receiving tranexamic acid experienced significantly more complications compared with placebo (odds ratio, 1.28 [95% CI, 1.02-1.60]; P=.03), with no significant difference in venous thromboembolism (odds ratio, 1.68 [95% CI, 0.95-3.07]; P=.08).

Conclusions and Relevance  Among patients undergoing liver resection for a cancer-related indication, tranexamic acid did not reduce bleeding or blood transfusion but increased perioperative complications.

DOI: 10.1001/jama.2024.11783

Source: https://jamanetwork.com/journals/jama/fullarticle/2822555