氨甲环酸序贯利伐沙班在全髋关节置换术中的效果评价

Study on efficacy and safety of sequential rivaroxaban use in reducing blood loss after applying tranexamic acid in total hip arthroplasty

目的探索氨甲环酸(TXA)序贯利伐沙班在全髋关节置换术(THA)围术期减少出血及预防血栓的疗效。方法筛选从2012-2015年在广西壮族自治区人民医院拟行初次一侧THA的患者,共150例,用随机对照的实验方法将患者分为5组,分别命名为A、B、C、D、E组,每组患者各30例。A组患者作为空白组,不应用药物干预;B组在手术前应用10mg/kg TXA溶于100mL生理盐水静脉滴注;C组在手术前应用15mg/kg TXA溶于100mL生理盐水静脉滴注;D组在手术前及3h后分别应用15mg/kg TXA溶于100mL生理盐水静脉滴注;E组在手术前应用15 mg/kg TXA静脉滴注,关闭切口时再局部应用1g TXA。术后6~12h视引流量予以抗凝,一般在引流量小于30mL/h口服利伐沙班10mg,按常规剂量抗凝至术后35d。统计5组患者术中失血量、术后引流量、隐性失血量、输血人数和输血率、术后开始抗凝及拔除引流管时间、术后第1天凝血酶原和部分活化凝血活酶时间、血红蛋白下降值及深静脉血栓(DVT)和肺栓塞(PE)的发生率。结果术中失血量、术后引流量、隐性失血量、输血人数和输血率、术后第1天血红蛋白下降值在5组患者之间比较差异有统计学意义(P<0.05);而D组患者术中出血量、术后引流量、隐性失血量、输血率、术后第1天Hb下降值、术后开始抗凝时间、术后拔除引流管时间与A组各项指标比较,差异有统计学意义(P<0.05)。所有患者在围术期及术后3个月内随访均未发生症状性DVT及PE。结论 THA应用TXA序贯利伐沙班是安全、有效的,且术前及3h后各应用15mg/kg TXA对减少THA失血量的效果最显著。

Objective To research the efficacy and safety of sequential rivaroxaban use in reducing blood loss after applying tranexamic acid（TXA）in total hip arthroplasty（THA）. Methods According to the design by the random control principle,150 pa- tients undergoing unilateral primary THA from September 2012 to June 2015 were selected and randomly divided into the group A, B,C,D and E （n=30）. The group A did not use TXA,the group B received intravenous drip of 10 mg/kg TXA at 10 rain before skin incision,the group C received intravenous drip.of 15 mg/kg TXA at 10 min before skin incision, the group D respectively re- ceived intravenous drip of 15 mL/kg TXA at 10 rain before skin incision and after 3 h,the group E received intravenous drip of 15 mL/kg TXA at 10 min before skin incision and articular cavity use of 1 g TXA before closing the incision. Oral 10 mg rivaroxaban was given at postoperative 6--12 h when the drainage volume was less than 30 mL/h and then the conventional dose was used until postoperative 35 d. The intraoperative blood loss, postoperative drainage volume, hidden blood loss, blood transfusion rate, postoper- ative anticoagulation time, time of removing drainage tube, postoperative prothrombin time on postoperative 1 d, activated partial thromboplastin time,descend value of hemoglobin, and occurrence rates of postoperative deep vein thrombosis （DVT） and pulmona- ry embolism （PE） were observed in the group A,B,C,D and E, Results The intraoperative blood loss,postoperative drainage vol- ume,hidden blood loss.blood transfusion rate and descend value of hemoglobin on postoperative 1 d had statistical differences a- mong 5 groups（P〈0. 05）. The are significant differences between the group D and A in the intraoperative blood loss,postoperative drainage volume, hidden blood loss, blood transfusion rate,descend value of hemoglobin on postoperative 1 d, postoperative antico- agulation time and removal drainage tube time（P〈0.05）. All cases had no symptomatic DVT and PE during the perioperative peri- od and postoperative 3-month outpatient or telephone follow-up, Conclusion Sequential rivaroxaban use after applying TXA during THA perioperative period is safe and effective. Moreover intravenous drip of 15 mL/kg TXA at 10 rain before skin incision and af- ter 3 h has most significant effect in reducing bleeding volume during THA perioperative period.