多次重复静脉应用氨甲环酸减少初次全髋关节置换术失血有效性与安全性的前瞻性对照研究

Efficacy and safety of multiple intravenous application of tranexamic acid for reducing perioperative bleeding during total hip arthroplasty:a prospective randomized controlled trial

目的探讨多次重复静脉应用氨甲环酸(tranexamic acid,TXA)减少初次全髋关节置换术(total hip arthroplasty,THA)围手术期失血的有效性及安全性。方法选择2014年12月至2015年9月拟行初次THA患者90例,按TXA的不同用法以数字表法随机分为3组。单次给药组:30例术前静脉滴注TXA20 mg/kg;重复给药组:30例术前静脉滴注TXA 20 mg/kg后,3 h再次静脉滴注TXA 10 mg/kg;多次给药组:30例术前静脉滴注TXA 20 mg/kg后,3、6 h再次静脉滴注TXA 10 mg/kg。3组均于术中3个时点局部使用总量1.5 g的TXA。主要指标为隐性失血量、术后血红蛋白下降最大值、总失血量、输血率、术后血栓发生事件;次要指标为术后引流量、住院时间及伤口并发症。结果多次给药组隐性失血量(308.21±221.91)ml、总失血量(589.34±190.85)ml、血红蛋白下降最大值(20.07±6.06)g/L、均明显低于重复给药组(509.91±237.82)ml、(815.57±234.31)ml、(25.53±8.30)g/L、和单次给药组(681.86±380.82)ml、(1037.53±367.68)ml、(29.60±10.30)g/L,差异有统计学意义(P<0.05)。重复给药组总失血量为(815.57±234.31)ml、引流量(180.67±77.68)ml低于单次给药组(1037.53±367.68)ml、(240.67±81.79)ml,差异有统计学统意义(P<0.05)。血红蛋白下降最大值(25.53±8.30)g/L低于单次给药组(29.60±10.30)g/L,差异无统计学统意义(P>0.05)。3组患者输血率均为0,无一例出现肺栓塞及下肢深静脉血栓。结论在THA术中使用TXA可以减少患者围手术期隐性失血及血红蛋白丢失,且不增加血栓风险。多次重复应用TXA可有效安全的进一步减少围手术期隐性失血及血红蛋白丢失,其中以3 h、6 h多次给药效果显著。

Objective To explore the efficacy and safety of multiple intravenous application of tranexamic acid（ TXA） in reducing perioperative blood loss in primary unilateral total hip arthroplasty（ THA）. Methods A total of 90 patients undergoing THA between December 2014 and September 2015 were divided into 3 groups randomly. Single dose group： 20 mg/kg TXA was intravenously given before the operation in 30 patients. Double dose group： 30 patients received 20 mg/kg TXA before the operation and 10 mg/kg TXA again 3 hours later. Triple dose group： TXA was given at a dose of 20 mg/kg before the operation and twice thereafter, at 3-hour intervals. All patients were given a total of 1.5 g TXA during the operation at 3 time points. Hidden blood loss, the maximum hemoglobin（ Hb） drop, total blood loss, transfusion, embolism events, postoperative draining, length of stay and other complications were recorded. Results In the triple group, hidden blood loss was（ 308.21 ± 221.91） ml, the maximum Hb drop was（ 20.07 ± 6.06） g/L, total blood loss was（ 589.34 ± 190.85） ml, which were significantly lower than those in the other 2 groups. Total blood loss（ 815.57 ± 234.31） ml and postoperative draining（ 180.67 ± 77.68） ml of double dose group were also significantly lower than those of single dose group. No patients needed transfusion in any of the 3 groups. Pulmonary embolism and deep vein thrombosis（ DVT） were not observed in any group. Conclusions Intravenous application of tranexamic acid is effective in reducing hidden blood loss and hemoglobin loss without increasing the risk of embolic events. Meanwhile, triple dose intravenous application of TXA is better than single and double dose intravenous application.