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氨甲环酸在减少初次冠状动脉搭桥手术术后出血及输血方面有效:一项双盲、随机、安慰剂对照试验。

Tranexamic acid is effective in decreasing postoperative bleeding and transfusions in primary coronary artery bypass operations: a double-blind, randomized, placebo-controlled trial.

作者信息

Brown R S, Thwaites B K, Mongan P D

机构信息

Department of Surgery, Brooke Army Medical Center, Fort Sam Houston, Texas, USA.

出版信息

Anesth Analg. 1997 Nov;85(5):963-70. doi: 10.1097/00000539-199711000-00003.

DOI:10.1097/00000539-199711000-00003
PMID:9356085
Abstract

UNLABELLED

We evaluated the effects of tranexamic acid (TA) administered before and after cardiopulmonary bypass (CPB) in a prospective, randomized, placebo-controlled, double-blind study of adult patients undergoing primary coronary artery bypass grafting surgery. Patients received placebo (n = 30) or TA 15 mg/kg before CPB, followed by a TA infusion of 1 mg x kg(-1) x h(-1) for 5 h (n = 30) or TA 15 mg/kg after CPB, followed by a TA infusion of 1 mg x kg(-1) x h(-1) for 5 h (n = 30). Demographic, medical, surgical, laboratory, mediastinal chest tube drainage (MCTD), hemoglobin loss, transfusion, and outcome data were collected. Allogenic blood product administration was tightly controlled. The demographic, medical, and surgical characteristics were similar in all three groups. The median postoperative MCTD and hemoglobin loss in the pre-CPB TA group (710 mL, 8.6 g) was significantly less (P < 0.001) compared with the control (1202 mL, 44.2 g) and post-CPB TA groups (1020 mL, 23.4 g). The percentage of patients who received no allogenic blood products was 27% for the pre-CPB TA group and 33% for the post-CPB TA group (not significant). These percentages were significantly lower than those in the placebo group (66%, P < 0.001). The median number of allogenic blood products administered to the pre-CPB TA group (0 units) was significantly less compared with the control group (4.5 units). The thromboelastogram and fibrinogen split product levels in the pre-CPB TA group indicated better platelet function and less activation of the fibrinolytic system compared with the other two groups (P < 0.05). There were no intergroup differences in reoperation, myocardial infarction, stroke, infections, or death. These data support the use of pre-CPB TA to decrease patient exposure to postcardiopulmonary bypass allogenic blood products.

IMPLICATIONS

In this randomized, placebo-controlled trial, we investigated the efficacy of tranexamic acid to decrease bleeding and blood transfusions after open-heart operations. Tranexamic acid administered before and during the operation was effective in decreasing both bleeding and transfusions. When tranexamic acid was administered immediately after the operation, it had a minor beneficial effect.

摘要

未标注

我们在一项针对接受初次冠状动脉搭桥手术的成年患者的前瞻性、随机、安慰剂对照、双盲研究中,评估了在体外循环(CPB)前后给予氨甲环酸(TA)的效果。患者接受安慰剂(n = 30)或在CPB前给予TA 15 mg/kg,随后以1 mg·kg⁻¹·h⁻¹的速度输注TA 5小时(n = 30),或在CPB后给予TA 15 mg/kg,随后以1 mg·kg⁻¹·h⁻¹的速度输注TA 5小时(n = 30)。收集了人口统计学、医学、手术、实验室、纵隔胸管引流(MCTD)、血红蛋白丢失、输血及结局数据。异体血制品的使用受到严格控制。三组患者的人口统计学、医学和手术特征相似。与对照组(1202 mL,44.2 g)和CPB后TA组(1020 mL,23.4 g)相比,CPB前TA组术后MCTD中位数和血红蛋白丢失量(710 mL,8.6 g)显著更低(P < 0.001)。未接受异体血制品的患者比例,CPB前TA组为27%,CPB后TA组为33%(无显著差异)。这些比例显著低于安慰剂组(66%,P < 0.001)。CPB前TA组给予的异体血制品中位数(0单位)显著少于对照组(4.5单位)。与其他两组相比,CPB前TA组的血栓弹力图和纤维蛋白原降解产物水平表明血小板功能更好,纤溶系统激活程度更低(P < 0.05)。在再次手术、心肌梗死、中风、感染或死亡方面,组间无差异。这些数据支持在CPB前使用TA以减少患者体外循环后异体血制品的暴露。

启示

在这项随机、安慰剂对照试验中,我们研究了氨甲环酸减少心脏直视手术后出血和输血的疗效。手术前及手术期间给予氨甲环酸可有效减少出血和输血。手术后立即给予氨甲环酸有轻微的有益效果。

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