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氨甲环酸在冠状动脉搭桥手术中的局部应用:一项双盲、前瞻性、随机、安慰剂对照研究。

Topical use of tranexamic acid in coronary artery bypass operations: a double-blind, prospective, randomized, placebo-controlled study.

作者信息

De Bonis M, Cavaliere F, Alessandrini F, Lapenna E, Santarelli F, Moscato U, Schiavello R, Possati G F

机构信息

Departments of Cardiac Surgery, Anesthesiology, and Institute of Hygiene and Public Health, Catholic University, Rome, Italy.

出版信息

J Thorac Cardiovasc Surg. 2000 Mar;119(3):575-80. doi: 10.1016/s0022-5223(00)70139-5.

DOI:10.1016/s0022-5223(00)70139-5
PMID:10694619
Abstract

OBJECTIVES

We sought to investigate the effect of topical application of tranexamic acid into the pericardial cavity in reducing postoperative blood loss in coronary artery surgery.

METHODS

A prospective, randomized, double-blind investigation with parallel groups was performed. Forty consecutive patients undergoing primary coronary surgery were randomly assigned to group 1 (tranexamic acid group) or group 2 (placebo group). Tranexamic acid (1 g in 100 mL of saline solution) or placebo was poured into the pericardial cavity and over the mediastinal tissues before sternal closure. The drainage of mediastinal blood was measured hourly.

RESULTS

Chest tube drainage in the first 24 hours was 485 +/- 166 mL in the tranexamic acid group and 641 +/- 184 mL in the placebo group (P =.01). Total postoperative blood loss was 573 +/- 164 mL and 739 +/- 228 mL, respectively (P =.01). The use of banked donor blood products was not significantly different between the two groups. Tranexamic acid could not be detected in any of the blood samples blindly collected from 24 patients to verify whether any systemic absorption of the drug occurred. There were no deaths in either group. None of the patients required reoperation for bleeding.

CONCLUSIONS

Topical application of tranexamic acid into the pericardial cavity after cardiopulmonary bypass in patients undergoing primary coronary bypass operations significantly reduces postoperative bleeding. Further studies must be carried out to clarify whether a more pronounced effect on both bleeding and blood products requirement might be seen in procedures with a higher risk of bleeding.

摘要

目的

我们旨在研究在心包腔内局部应用氨甲环酸对减少冠状动脉手术术后失血的效果。

方法

进行了一项前瞻性、随机、双盲的平行组研究。40例连续接受初次冠状动脉手术的患者被随机分为第1组(氨甲环酸组)或第2组(安慰剂组)。在胸骨关闭前,将氨甲环酸(1克溶于100毫升盐溶液中)或安慰剂倒入心包腔及纵隔组织上。每小时测量纵隔引流量。

结果

氨甲环酸组术后24小时胸腔引流液为485±166毫升,安慰剂组为641±184毫升(P = 0.01)。术后总失血量分别为573±164毫升和739±228毫升(P = 0.01)。两组间库存供血制品的使用无显著差异。在从24例患者中盲采的任何血样中均未检测到氨甲环酸,以验证药物是否发生全身吸收。两组均无死亡病例。无一例患者因出血需要再次手术。

结论

在接受初次冠状动脉搭桥手术的患者体外循环后在心包腔内局部应用氨甲环酸可显著减少术后出血。必须开展进一步研究以明确在出血风险较高的手术中,对出血和供血制品需求是否可能有更显著的效果。

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