氨甲环酸结合术后引流管临时夹闭降低单侧全膝置换术后失血量的有效性及安全性

Use of intravenous tranexamic acid combined with temporary clamping of drain reduce postoperative blood loss in totalknee arthroplasty

目的评估单次静脉应用氨甲环酸结合术后引流管临时夹闭降低单侧全膝关节置换（total knee arthroplas．ty，TKA）术后失血量的有效性与安全性。方法2012年7月至2013年6月，前瞻l生选择行初次单侧全膝关节置换患者，随机分为氨甲环酸组（松止血带前15min静脉注入15mg／kg氨甲环酸）和安慰剂组（松止血带前15rain给予等量生理盐水）；两组术后均予引流管临时夹闭4h。记录两组术后12h引流量、总引流量、输血量、输血人数、术后第1、3、5天血红蛋白值、红细胞压积、术后下肢淤斑发生率、术后24hD-二聚体值、术后并发症及术后5-7d下肢静脉超声筛查有无深静脉血栓（DVT），并对两组进行比较。结果最终77例患者进入统计学分析。氨甲环酸组39例，安慰剂组38例；两组的人口学资料均匹配。术后12h引流量为（142．6±202．1）ml（氨甲环酸组）和（257．4±245-3）ml（安慰剂组）、术后隐性失血量为（685．4±40．3）ml（氨甲环酸组）和（834．3±200．0）ml（安慰剂组）、总失血量为（962．2±286．2）ml（氨甲环酸组）和（1168．4±455．4）ml（安慰剂组）、术后第3天血红蛋白值为（104．0±12．7）g／L（氨甲环酸组）和（96．0±13．4）g／L（安慰剂组）、术后24hD-二聚体值为（11．8±1．51rag／L（氨甲环酸组）和（22．1±3．4）mg／L（安慰剂组），以上指标两组比较差异均有统计学意义。术后下肢淤斑发生率氨甲环酸组（2．6％，1，39）低于安慰剂组（18．4％，7／38）。术后总引流量、围手术期输血率两组比较差异无统计学意义；氨甲环酸组远端深静脉血栓发生率为10．3％（4／39），安慰剂为7．9％（3／38），两组比较差异元统计学意义；氨甲环酸组术后第7天出现1例症状性肺栓塞。结论TKA术后松止血带前15min按15mg／kg单次静脉注入氨甲环酸并结合术后临时夹闭引流管4h，可有效、安全控制术后失血量。

Objective To evaluate the efficacy and safety of one dose tranexamic acid combined with temporary drain lamping in primary unilateral total knee arthroplasty （TKA）. Methods In a randomized, double-blind, placebo-controlled trial, 90 patients were randomized to receive 15 mg/kg of tranexamic acid or an equivalent volume of placebo （normal saline solution） 15 min before the tourniquet deflated. Both groups were combined with drain lamping for 4 h. The first 12 h drainage, total drainage, blood transfusion rate, postoperative 1 d, 3 d, 5 d hemoglobin, hematocrit, postoperative 24 h D-dimer, incidence of lower limb ec-chymosis and postoperative complications were recorded. Doppler ultrasound applied in all patients 5-7 days postoperation to evaluate the incidence of deep vein thrombosis. Results Seventy-seven patients were included in the intention-to-treat analysis （39 cases in tranexamic acid group and 38 cases in placebo group）. The demographic data was well matched in both groups. The mean drainage in the first 12 hours （142.6±202.1 ml）, total blood loss （962.2±286.2 ml）, and hidden blood loss （685.4±40.3 ml） was reduced in the tranexamic acid group in comparison with the placebo group （257.4±245.3 ml; 1168.4±455.4 ml; 834.3±200.0 ml）. The postoperative 3 d hemoglobin levels were higher in the tranexamic acid groups （104.0±12.7 g/L） in comparison with the placebo group （96.0±13.4 g/L）. The incidence of postoperative lower limb ecchymosis was lower in tranexamie acid group （2.6%, 1/ 39） in comparison with the placebo group （18.4%, 7/38）. There was no significant difference in total drainage, rates of transfusion, incidence of deep vein thrombosis or pulmonary embolism between the two groups. Conclusion Application of intravenous infusion of 15 mg/kg tranexamic acid 15 min before the tourniquet deflated combined with 4 h drain lamping in TKA is effective and safe.