全膝关节置换术中氨甲环酸不同用法的疗效与安全性研究

Different Regimen of Tranexamic Acid Application on TKA:The Safety and Efficacy Analysis

目的全膝关节置换术中使用氨甲环酸最为常用的给药方案是两次静脉给药,但在临床操作中可操作性较差。本研究旨在比较单次氨甲环酸静脉注射结合局部关节腔灌注与传统的两次静脉给药的有效性及安全性。方法2015年4月至2016年1月,我们共收治187例行单侧全膝关节置换术(total knee arthroplasty,TKA)的内翻畸形的骨关节炎患者,随机分为实验组与对照组,实验组91例,松止血带前20min给予1g氨甲环酸静脉滴注,关闭关节囊后给予关节腔1g氨甲环酸灌注;对照组96例,松止血带前20min给予1g氨甲环酸静脉滴注,3h后追加同等剂量的氨甲环酸。两组患者术后均常规放置引流管,术后夹闭4h。术后1、3、5d检测血常规、D-二聚体、纤维蛋白原降解产物(fibrinogen degradation product,FDP)。术后第5~7天安排患者行双下肢深静脉彩超观察深静脉血栓发生率。采用Student’st test,Pearson’s chi-square test,and Fisher’s exact test进行统计学分析。结果实验组总失血量为(619±272)mL,对照组为(676±237)mL,两组相比差异无统计学意义(P=0.78)。实验组术后引流量为(171±152)mL,对照组为(241±174)mL,两组相比差异有统计学意义(P=0.023)。实验组术后输血率9.9%(9/91),对照组为11.5%(11/96),两组相比差异无统计学意义(P=0.23)。术后7d两组各有6例深静脉血栓发生,均为孤立性小腿肌间隙血栓,给予常规抗凝治疗后未进展为近端深静脉血栓或者肺栓塞。深静脉血栓发生率两组相比差异无统计学意义。结论氨甲环酸静脉滴注结合局部关节腔灌注具有与两次静脉给药类似的临床疗效与安全性,但因其单次给药,临床可操作性更好。

Objective To explore the perioperative efficiency and safety of different regimen of tranexamic acid（TA）in total knee arthroplasty（TKA）.Methods We prospectively enrolled 187 patients operated on from April 1,2015 to January 31,2016 and randomly divided them in to two groups which were then named TA group（1g of TA infused intravenous 20 minutes before tourniquet deflation and one dose of 1g TA injected into articular cavity）and control group（1g of TA infused intravenous 20 minites before tourniquet deflation andanother dose 3hours after operation）.Then we detectedthe change in blood routine,D-dimer,FDP and observe the incidence of deep venous thrombosisbetween the two groups.Results The total blood loss was less for patients in the TA group than for the control group：（619±272）mL versus（676±237）mL,respectively,there was no significant difference between the two groups（P=0.78）.However,the total amount of drainage after operation in the two groups was significantly different：（171±152）mL versus（241±174）mL（P=0.023）.There was no significant difference in blood transfusion rate between the two groups：9.9% versus 11.5%（P=0.23）,and the incidence of DVT was similar for both groups.Conclusion Compared to two intravenous administration,tranexamic acid intravenous drip combined with local joint cavity perfusion has the same efficiency and safety,andhigher clinical operability.