| 姜慧芳,楼丽姝,许平波.氨甲环酸在肝切除术患者中的应用：HeLiX随机临床试验研究解读[J].肿瘤学杂志,2025,31(3):266-272. |
| 氨甲环酸在肝切除术患者中的应用：HeLiX随机临床试验研究解读 |
| Administration of Tranexamic Acid in Patients Undergoing Liver Resection: Interpretation of HeLiX Randomized Clinical Trial |
| 投稿时间：2025-02-05 |
| DOI：10.11735/j.issn.1671-170X.2025.03.B014 |
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| 中文关键词: 氨甲环酸 肝切除术 红细胞输注 随机对照试验 |
| 英文关键词:tranexamic acid liver resection red blood cell transfusion randomized controlled trial |
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| 中文摘要: |
| 摘 要：在许多类型的手术中应用氨甲环酸（tranexamic acid，TXA）可减少出血量和输血次数，但其对因癌症相关指征接受肝切除术患者的影响仍不清楚。为评估TXA对肝切除术患者出血、输血和围手术期并发症的影响，开展了此项多中心、随机、安慰剂对照临床研究。2014年12月1日至2022年11月8日，加拿大及美国共11家中心的1 384例患者符合入组标准，并随机分配至TXA组或安慰剂组。主要研究终点为手术开始至术后第7 d红细胞输注。最终分析1 245例患者，TXA组16.32%患者（n=101）接受了红细胞输注，安慰剂组14.54%患者（n=91）接受了红细胞输注（OR=1.15，95%CI：0.84~1.56，P=0.38）。术中失血量（817.30 mL vs 836.70 mL，P=0.75）和术后0~7 d内总失血量（1 504.00 mL vs 1 551.20 mL，P=0.38）在两组之间无统计学差异。与安慰剂组相比，接受TXA治疗的患者并发症明显增多（OR=1.28，95%CI：1.02~1.60，P=0.03），静脉血栓栓塞无显著性差异（OR=1.68，95%CI：0.95~3.07，P=0.08）。在因癌症相关指征而行肝切除术的患者中，TXA并没有减少出血或输血，反而增加了围手术期并发症。因此，在尚未明确证明TXA有效的外科手术中采用TXA应持谨慎态度。 |
| 英文摘要: |
| Abstract： Tranexamic acid (TXA) 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. To evaluate the impact of TXA on bleeding， transfusion， and perioperative complications in patients undergoing hepatectomy， a multicenter randomized clinical trial of TXA vs placebo was conducted at 11 centers in Canada and the United State from December 1， 2014 to November 8， 2022. The primary outcome was proportion of red blood cell transfusion within 7 days of surgery. The primary analysis included 1 245 participants. Perioperative characteristics were similar between groups. Red blood cell transfusion occurred in 16.32% (101/619) of participants in the TXA group and 14.54% (91/626) in the placebo group (OR=1.15， 95%CI： 0.84~1.56， P=0.38). The intraoperative blood loss (817.30 mL vs 836.70 mL， P=0.75) and total estimated blood loss over 7 days (1 504.00 mL vs 1 551.20 mL， P=0.38) were similar between groups. Participants receiving TXA experienced significantly more complications compared with placebo (OR=1.28， 95%CI： 1.02~1.60， P=0.03)， with no significant difference in venous thromboembolism (OR=1.68， 95%CI： 0.95~3.07， P=0.08). Among patients undergoing liver resection for a cancer-related indication， TXA did not reduce bleeding or blood transfusion but increased perioperative complications. Therefore， caution should be exercised when using TXA in surgical procedures where it has not been clearly demonstrated to be effective. |
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