高剂量氨甲环酸输注显著降低心脏手术患者的红细胞输注需求

  Design, Setting, and Participants  Multicenter, double-blind, randomized clinical trial among adult patients undergoing cardiac surgery with cardiopulmonary bypass. The study enrolled 3079 patients at 4 hospitals in China from December 26, 2018, to April 21, 2021; final follow-up was on May 21, 2021.

  Source: https://jamanetwork.com/journals/jama/article-abstract/2794565

  附:英文原文

  中国医学科学院北京协和医科大学郑哲教授Tuán队比较了高剂量Yǔ低剂量氨甲环酸输注对心脏手术患Zhě红细胞输Zhù需求和不良事件的影响。相关论文于2022年7月26日发Biǎo在《Měi国医学会杂Zhì》上。

  Results  Among 3079 patients who were randomized to treatment groups (mean age, 52.8 years; 38.1% women), 3031 (98.4%) completed the trial. Allogeneic red blood cell transfusion occurred in 333 of 1525 patients (21.8%) in the high-dose group and 391 of 1506 patients (26.0%) in the low-dose group (risk difference [RD], 4.1% [1-sided 97.55% CI, ∞ to 1.1%]; relative risk, 0.84 [1-sided 97.55% CI, ∞ to 0.96; P=.004]). The composite of postoperative seizure, thrombotic events, kidney dysfunction, and death occurred in 265 patients in the high-dose group (17.6%) and 249 patients in the low-dose group (16.8%) (RD, 0.8%; 1-sided 97.55% CI, ∞ to 3.9%; P=.003 for noninferiority). Fourteen of the 15 prespecified secondary end points were not significantly different between groups, including seizure, which occurred in 15 patients (1.0%) in the high-dose group and 6 patients (0.4%) in the low-dose group (RD, 0.6%; 95% CI, 0.0% to 1.2%; P=.05).

  高Jì量组中有265名患者(17.6%)发生术后癫痫Fā作、血栓性事件、肾功能Bù全和死亡,低剂量组中有249名患者(16.8%)。15个预先指定的次要终Diǎn中有14个在两Zǔ间没有显著差Yì,其中高剂量组Yǒu15名患者(1.0%)癫痫发作,低剂量组有6名患者(0.4%)。

  Objective  To compare the efficacy and adverse events of high-dose vs low-dose tranexamic acid in patients undergoing cardiac surgery with cardiopulmonary bypass.

  Main Outcomes and Measures  The primary efficacy end point was the rate of allogeneic red blood cell transfusion after start of operation (superiority hypothesis), and the primary safety end point was a composite of the 30-day postoperative rate of mortality, seizure, kidney dysfunction (stage 2 or 3 Kidney Disease: Improving Global Outcomes [KDIGO] criteria), and thrombotic events (myocardial infarction, ischemic stroke, deep vein thrombosis, and pulmonary embolism) (noninferiority hypothesis with a margin of 5%). There were 15 secondary end points, including the individual components of the primary safety end point.

  为了比较高剂量和低Jì量氨甲Huán酸在体外循Huán心脏手术患者中的疗效和不Liáng事件,研Jiū组对接受体外循环心脏手术的成年患者中进行了一项多中心、Shuāng盲、随机临Chuáng试验。2018年12月26日至2021年4Yuè21日,Zài中国4家医院招募了3079名患者;最终随访时间为2021年5月21日。

  Abstract:

  Issue&Volume: 2022/07/26

  将参与者随机分组,其中1525例接受高剂量氨甲环酸方案,包括30 mg/kg剂量、16 mg/kg/h维持剂量和2 mg/kg初始剂量,1506例接Shòu低剂量方案,包括10 mg/kg剂量、2 mg/kg/h维持剂量和1 mg/kg初始剂量。主要Liáo效终点为术后异基因红细胞输注(优势假设),Zhǔ要安全终点是术后30天死亡Shuài、癫痫发作、肾功能不全(2或3期肾病:改善Zhěng体预后[KDIGO]标准)和血栓性事件(心肌梗死、缺血性中风、深静脉血栓形成和肺栓塞)的综合结局(非劣性假设边缘为5%)。共有15个次要终点,包括主要安全终Diǎn的各个组成Bù分。

  Author: Jia Shi, Chenghui Zhou, Wei Pan, Hansong Sun, Sheng Liu, Wei Feng, Weijian Wang, Zhaoyun Cheng, Yang Wang, Zhe Zheng, OPTIMAL Study Group, Liqing Wang, Yunhu Song, Chuntao Yu, Xin Wang, Xianqiang Wang, Hongguang Fan, Yan Yang, Fei Xu, Ge Gao, Yan Zhang, Haojie Li, Wei Li, Jing Li, Fuxia Yan, Su Yuan, Yan Zhao, Yue Zhang, Bingyang Ji, Heng Zhang, Jiamin Liu, Yan Ma, Juan Du, Zujun Chen, Li Shi, Yuxiu Fan, Hongqi Lin, Taofu Wang, Ting Lu, Zheng Dai, Chunmei Xie

  Importance  Tranexamic acid is recommended for reducing blood loss and transfusion in cardiac surgery. However, it remains unknown whether a high dose of tranexamic acid provides better blood-sparing effect than a low dose without increasing the risk of thrombotic complications or seizures in cardiac surgery.

  Conclusions and Relevance  Among patients who underwent cardiac surgery with cardiopulmonary bypass, high-dose compared with low-dose tranexamic acid infusion resulted in a modest statistically significant reduction in the proportion of patients who received allogeneic red blood cell transfusion and met criteria for noninferiority with respect to a composite primary safety end point consisting of 30-day mortality, seizure, kidney dysfunction, and thrombotic events.

  在3079名随机接受治疗的患者中(平均年龄为52.8岁;38.1%为女性),3031名(98.4%)完成了试Yàn。高剂量组1525例患者中有333例(21.8%)发生异基因红细胞输注,低剂量组1506例患者中有391例(26.0%),相对Fěng险为0.84,组间差Yì显著。

  Interventions  Participants received either a high-dose tranexamic acid regimen comprising a 30-mg/kg bolus, a 16-mg/kg/h maintenance dose, and a 2-mg/kg prime (n=1525) or a low-dose regimen comprising a 10-mg/kg bolus, a 2-mg/kg/h maintenance dose, and a 1-mg/kg prime (n=1506).

  氨甲环酸Pī推荐用于减少心脏手术中De失血和输血。然而,高剂量的氨甲环酸是Pǐ比低剂量的氨甲环酸具有更好的血液保护效果,Qiě不会增加心脏手术中血栓并发症或癫痫发作的风险,目前尚不清楚。

  DOI: 10.1001/jama.2022.10725

  Yàn究结果表明,对于接受体外循环心脏手术的患者,与低剂量氨甲环酸输注相比,高剂量氨甲环酸输注导致接受异基因红细胞输注的患者比例在统计学上显著降低,并符合复合主要安全终点的非劣效性标准,Bāo括30天死亡率、癫痫发作、肾功能Zhàng碍和血栓事件。

  Title: Effect of High- vs Low-Dose Tranexamic Acid Infusion on Need for Red Blood Cell Transfusion and Adverse Events in Patients Undergoing Cardiac Surgery: The OPTIMAL Randomized Clinical Trial