Department of Anesthesia, Toronto Western Hospital, University of Toronto, 2MC-434, 399 Bathurst Street, Toronto, ON M5T 2S8, Canada.
J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518.
Topical application of tranexamic acid to bleeding wound surfaces reduces blood loss in patients undergoing some major surgeries, without systemic complications. The objective of the present trial was to assess the efficacy and safety of the topical application of tranexamic acid on postoperative blood loss in patients undergoing primary unilateral total knee arthroplasty with cement.
In a prospective, double-blind, placebo-controlled trial, 124 patients were randomized to receive 1.5 or 3.0 g of tranexamic acid in 100 mL of normal saline solution or an equivalent volume of placebo (normal saline solution) applied into the joint for five minutes at the end of surgery. The primary outcome was blood loss calculated from the difference between the preoperative hemoglobin level and the corresponding lowest postoperative value or hemoglobin level prior to transfusion. The safety outcomes included Doppler ultrasound in all patients and measurement of plasma levels of tranexamic acid one hour after release of the tourniquet.
Twenty-five patients were withdrawn for various reasons; therefore, ninety-nine patients were included in the intention-to-treat analysis. The postoperative blood loss was reduced in the 1.5 and 3-g tranexamic acid groups (1295 mL [95% confidence interval, 1167 to 1422 mL] and 1208 mL [95% confidence interval, 1078 to 1339 mL], respectively) in comparison with the placebo group (1610 mL [95% confidence interval, 1480 to 1738 mL]) (p < 0.017). The postoperative hemoglobin levels were higher in the 1.5 and 3.0-g tranexamic acid groups (10.0 g/dL [95% confidence interval, 9.5 to 10.4 g/dL] and 10.1 g/dL [95% confidence interval, 9.8 to 10.5 g/dL], respectively) in comparison with the placebo group (8.6 g/dL [95% confidence interval, 8.2 to 9 g/dL]) (p < 0.017). With the numbers studied, there was no difference in the rates of deep-vein thrombosis or pulmonary embolism between the three groups. Minimal systemic absorption of tranexamic acid was observed.
At the conclusion of a total knee arthroplasty with cement, topical application of tranexamic acid directly into the surgical wound reduced postoperative bleeding by 20% to 25%, or 300 to 400 mL, resulting in 16% to 17% higher postoperative hemoglobin levels compared with placebo, with no clinically important increase in complications being identified in the treatment groups.
在某些大手术中，将氨甲环酸直接涂在出血的伤口表面可以减少失血量，且不会引起全身性并发症。本试验的目的是评估在使用骨水泥的初次单侧全膝关节置换术中，局部应用氨甲环酸对术后失血量的疗效和安全性。
在一项前瞻性、双盲、安慰剂对照试验中，124 名患者随机分为三组，分别在手术结束时向关节内注入 1.5 或 3.0 g 氨甲环酸（溶于 100 mL 生理盐水）或等量安慰剂（生理盐水），持续 5 分钟。主要结局是根据术前血红蛋白水平与术后最低值或输血前的血红蛋白水平之间的差异计算失血量。安全性结局包括所有患者的多普勒超声检查和止血带释放后 1 小时测量氨甲环酸的血浆水平。
由于各种原因，有 25 名患者退出研究，因此，99 名患者被纳入意向治疗分析。与安慰剂组（1610 毫升[95%置信区间，1480 至 1738 毫升]）相比，1.5 克和 3.0 克氨甲环酸组的术后失血量减少（分别为 1295 毫升[95%置信区间，1167 至 1422 毫升]和 1208 毫升[95%置信区间，1078 至 1339 毫升]）（p < 0.017）。与安慰剂组（8.6 g/dL[95%置信区间，8.2 至 9 g/dL]）相比，1.5 克和 3.0 克氨甲环酸组的术后血红蛋白水平较高（分别为 10.0 g/dL[95%置信区间，9.5 至 10.4 g/dL]和 10.1 g/dL[95%置信区间，9.8 至 10.5 g/dL]）（p < 0.017）。根据研究人数，三组之间深静脉血栓形成或肺栓塞的发生率无差异。观察到氨甲环酸的系统吸收很少。
在使用骨水泥的全膝关节置换术结束时，将氨甲环酸直接涂在手术伤口上可减少 20%至 25%的术后出血，即减少 300 至 400 毫升，与安慰剂相比，术后血红蛋白水平提高 16%至 17%，而治疗组并未发现有临床意义的并发症增加。
