随机双盲安慰剂对照研究全膝关节置换中使用氨甲环酸的有效性和安全性

The efficacy and safety of tranexamic acid in total knee arthroplasty: a prospective,randomized,double-blind,placebo-controlled study

[目的]前瞻性评估全膝关节置换术（TKA）中使用氨甲环酸（tranexamic acid，TNA）的有效性和安全性。[方法]2011年4月～2012年4月，选择90例行单侧TKA术患者，随机分为TNA组（n=45）和安慰剂组（n=45）。TNA组，在松止血带前15min静脉给予15mg／kg剂量的TNA；安慰剂组给予等量的生理盐水。记录两组术中失血量，术后12h引流量，总引流量，隐性失血量，总失血量，输血量，输血人数，术后第1、3、5d血红蛋白，红细胞压积，血小板，D一二聚体，下肢瘀斑人数，术后1周下肢彩超检查有无深静脉血栓（DVT），并对两组患者资料进行比较。[结果]TNA组失访6例，最终39例患者进入统计分析；对照组失访7例，最终38例患者进入统计分析。两组患者在年龄、身高、体重、MBI、性别、合并疾病数量、术前VAS评分、KSS评分、术前Hgb、Hct肆D-二聚体值差异均无统计学意义（P〉0．05），具有可比性。两组患者术后12h引流量、总引流量、隐性失血量及总失血量差异均有统计学意义（P〈0．05）；两组术后24hD-二聚体值差异有统计学意义（P〈0．05）；两组患者ngb在术后第3d达最低值，且差异有统计学意义（P〈0．05），而术后第1、5dHgb差异无统计学意义（P〉0．05）；TNA组和对照组分别有3例（共1200ml）和4例（共1400ml）患者接受异体输血，差异无统计学意义（P〉0．05）。TNA组和对照组下肢远端DVT分别有4例和3例，发生率差异无统计学意义（P〉0．05）。TNA组和对照组下肢发现瘀斑分别有1例和7例，差异有统计学意义（P〈0．05）。[结论]TKA中在松止血带前15min静脉使用15mg／kg剂量的TNA，能够减少TKA术后失血量，而不增加DVT的风险。

[ Objective] To assess the efficacy and safety of application of tranexamic acid （TNA） following total knee arthroplasty （TKA）. [ Method] From April 2011 to April 2012,90 unilateral TKA patients were randomly divided into TNA group （ n = 45 ） or placebo group （ n = 45 ）. TNA group received tourniquet 15min before intravenous 15 mg/ kg dose of TNA ; pla- cebo group received normal saline. These data were recorded, including intraoperative blood loss, postoperative drainage at 12 h, total drainage volume, hidden blood loss,total blood loss, transfusion volues, the number of transfusion, level of haemoglobin, hetnatoerit at postoperative 1 d, 3 d,5 d, platelets, D - dimer. Doppler ultrasonography was performed at 7 days after surgery. [ Result]Six patients in TNA group and 7 patients in placebo group lost to follow - up. The remaining 39 patients in TNA group and 38 patients in placebo group were entered the final statistical analysis. There were not statistically significant differences in age, height, weight, MBI, gender, number of comorbidities, preoperative VAS score, KSS score, preoperative Hgb, Hct, and D - dimer （ P 〉 0. 05 ）. The drainage at 12 h, the total drainage volume, hidden blood loss and total blood loss was lower in the TNA group than in the placebo group （ P 〈 0.05 ）. Postoperative 24 h D - dimer values was lower in the TNA group than in the placebo group （ P 〈 0.05 ）. The level of Hgb in two groups reached the lowest value at third day after surgery, and the level of Hgb was higher in the TNA group than in the placebo group （P 〈 0.05 ）. But the level of Hgb was no significant difference at postoperative 1,5 days （ P 〉 0.05 ）. The rate of transfusion was similar in both groups （ P 〉 0.05 ）. The prevalence of deep - vein thrombosis （DVT） was 3 （7.9%） in the placebo group and 4 （10.3 % ） in the TNA group （P 〉 0.05 ）. There were 1 patient with bruise in TNA group and 7 patients in placebo group, the difference was statistically significant （P 〈 0.05 ）. [ Conclusion] The use of TNA could reduce blood loss significantly without any adverse effect following TKA.