全髋关节置换术中局部与静脉应用同等剂量氨甲环酸止血效果的前瞻性随机对照研究

A prospective randomized controlled study on the hemostatic effect of local and intravenous application of the same dose of tranexamic acid in total hip arthroplasty

背景:静脉及局部应用氨甲环酸(tranexamic acid,TXA)均能有效减少全髋关节置换术(total hip arthroplasty,THA)围术期出血量及输血率。但局部应用TXA是否能与静脉应用同等剂量TXA的止血效果相当尚不明确。目的:对比THA中局部应用TXA与静脉应用同等剂量TXA的止血效果。方法:2017年1月至2017年12月前瞻性纳入拟行初次单侧THA的患者116例,随机分为2组,每组58例。静脉组:皮肤切开前10 min给予静脉输注1 g TXA,3 h后再次静脉输注1 g TXA。局部组:术中及关闭切口前局部应用总剂量2 g的TXA。有效性指标包括围术期总失血量、输血率、引流量、术后第1日及第3日血红蛋白(hemoglobin,Hb)下降值;安全性指标包括深静脉血栓(deep vein thrombosis,DVT)及肺栓塞(pulmonary embolism,PE)发生率。结果:局部组患者的围术期平均总出血量、平均术后引流量、术后第1日及第3日Hb下降值均高于静脉组,均有统计学差异(P<0.05)。局部组患者的输血率高于对照组,但无统计学差异(P>0.05)。两组DVT发生率无统计学差异,两组均未发生PE。结论:THA中局部应用2 g TXA不能达到静脉应用2 g TXA相同的止血效果,若预期达到与静脉应用TXA相同的止血效果,可能需要局部应用更高剂量的TXA。

Background: Both topical and intravenous applications of tranexamic acid(TXA)are effective and safe to controlblood loss and transfusion in total hip arthroplasty(THA). However, it is still unclear that whether topical TXA is equal to thesame dose of intravenous administration in reducing blood loss during THA. Objective: To investigate the hemostatic effects oftopical TXA and intravenous TXA of the same dose on reducing blood loss during THA. Methods: A total of 116 patients plan-ning to receive first unilateral THA from January 2017 to December 2017 were included and divided into topical TXA group(T-TXA group, n=58)using a total of 2 g topical TXA during the operation and before the incision close and intravenous TXAgroup(IV-TXA group, n=58)infused 1 g TXA before the operation and followed another 1 g TXA three hours later randomly.The efficacy outcomes included total blood loss, transfusion rate, total drainage volume and hemoglobin drop at the first andthird days after the operation. The safety outcomes included incidences of deep vein thrombosis(DVT)and symptomatic pulmo-nary embolism(SPE). Results: The total blood loss, mean postoperative drainage volume and hemoglobin drop at the first andthird days after the operation were higher in T-TXA group than in IV-TXA group(P<0.05). Although the difference in transfu-sion rate was not statistically significant between the two groups(P >0.05), it was a little higher in T-TXA group. There was nosignificant difference in DVT incidence between the two groups and no SPE occurred in both groups. Conclusions: Comparedwith topical 2 g TXA,the same dose of intravenous application is more effective regarding to reducing blood loss without sacrific-ing the safety in THA, therefore, a higher topical dose might be required to get the similar good efficacy as intravenous TXA.