关节腔内应用与静脉应用氨甲环酸在初次单侧全膝关节置换术中疗效比较的Meta分析

Tropical versus intravenous tranexamic acid treatment in primary unilateral total knee arthroplasty: a meta-analysis of randomized controlled trials

目的比较关节腔内和静脉应用的氨甲环酸在初次单侧全膝关节置换术中的疗效。方法检索数据库Pub Med,Scientce Direct,CENTRAL,Embase和CNKI内的随机对照试验,分析评估关节腔内和静脉应用氨甲环酸的有效性和安全性。主要分析是失血相关指标(失血量,引流量,最大血红蛋白下降值),输血率和血栓相关并发症(肺栓塞和深静脉血栓)的结果。必要时进行亚组分析。结果共查得602篇文献,最终纳入8篇文献(965例)。结果显示:关节腔内和静脉应用氨甲环酸,输血率各组间差异无统计学意义(RR=1.00,95%CI=0.68~1.45,P=0.99),组间不存在显著的统计异质性(P=0.39,I^2=6%);最大血红蛋白下降值各组间差异无统计学意义(MD=0.43,95%CI=-0.08~0.95,P=0.10),但组间存在显著的统计异质性(P<0.001,I^2=93%);总失血量各组间差异无统计学意义(MD=-5.65,95%CI=-198.36~187.05,P=0.95),但组间存在显著的统计异质性(P<0.001,I^2=98%);总引流量各组间差异无统计学意义(MD=40.73,95%CI=-16.83~98.28,P=0.17),但组间存在显著的统计异质性(P<0.001,I^2=81%);血栓栓塞并发症发生率各组间差异无统计学意义(RR=1.11,95%CI=0.47~2.65,P=0.81),组间无显著的统计学异质性(P=0.68,I^2=0%)。结论关节腔内和静脉应用氨甲环酸有着类似的功效和临床价值,可以在不牺牲安全性的情况下减少失血和输血率。部分结论仍需更多的证据提供支持。

Objective To perform a meta-analysis to compare the efficacy of intra-articular and intravenous utilization of tranexamic acid in primary unilateral total knee arthroplasty. Methods All randomized controlled trials in the PubMed, ScientceDirect, CENTRAL, Embase and CNKI databases were retrieved to assess the effectiveness and safety of intra-articular and intravenous tranexamic acid regimen. Main analytical points： blood loss （ blood loss volume, drainage, maximal hemogiobin decrease ）, blood transfusion rate and thromboembolic complications （ pulmonary embolism and deep venous thrombosis ）. Subgroup analyzes were performed as necessary. Results A total of 602 articles were found and 8 randomized controlled clinical trials involving 965 patients were finally included. Our recta-analysis found no statistically significant differences in blood transfusion rate （ RR = 1.00, 95% CI = 0.68 - 1.45, P = 0.99 ） as well as within-group statistical heterogeneity （ P = 0.39, I2 = 6% ）. There were no significant differences in maximal drop of Hb （ MD = 0.43, 95% CI = -0.08 - 0.95, P = 0.10 ） while significant differences existed between groups （ P 〈 0.001, 12 = 93% ）. There were no significant differences in total blood loss （ MD = -5.65, 95% CI = -198.36 - 187.05, P = 0.95 ） while significant differences existed between groups （ P 〈 0.001, 12 = 98% ）. There were no significant differences in total drainage amount （ MD = 40.73, 95% CI = -16.83 - 98.28, P = 0.17 ） while significant differences existed between groups （ P 〈 0.001, 12 = 81% ）. There were no significant differences in thromboembolic complication rate （ RR = 1.11, 95% CI = 0.47 - 2.65, P = 0.81 ） as well as within-group statistical heterogeneity （ P = 0.68,12 = 0% ） between intra-articular and intravenous usage of tranexamic acid. Conclusions Intra-articular and intravenous tranexamic acid regimen have similar efficacy and clinical value in the reduction of blood loss and blood transfusion rate without sacrificing the safety of the operation.