局部应用氨甲环酸对膝关节置换术患者安全性与有效性的系统评价

The safety and effectiveness of the topical administration of tranexamic acid in total knee arthroplasty： a systematic review

目的系统评价局部应用氨甲环酸对膝关节置换术（total knee arthroplasty, TKA ）患者的有效性及安全性，以期为氨甲环酸临床应用方式的选择提供证据。方法计算机检索PubMed、EMbase、CENTRAL（2015年第3期）、万方数据知识服务平台、中国生物医学数据库（CBM）、中国知网（CNKI），检索时限定义为建库至2015年3月。查找有关局部应用氨甲环酸对TKA患者安全性与有效性的随机对照试验（randomized controlled trails, RCT）.由2名研究者严格按照纳入与排除标准独立筛选文献、并进行资料提取及方法学质量评价，采用RevMan5．3软件进行Meta分析。结果最终纳入16项RCT。其中10项采用空白或安慰剂作为对照，剩余6项采用静脉给药法（氨甲环酸）进行对照，共计1533例患者。Meta分析结果显示：与空白组相比，局部应用氨甲环酸可显著降低围手术期输血人数[比值比（oddsratio，OR）=0．3，95％CI（0．19-0．46）]（P〈0．01），显著降低患者总失血量[标准化均数差（standard mean difference, SMD ）=-1．13，95％CI（-1．27--1．00）]（P〈0．01），而深静脉血栓发生率差异没有统计学意义（P〉0．05）；与静脉给药法相比，围手术期输血人数、失血量、深静脉血栓发生率差异均没有统计学意义（P〉0．05）。结论局部应用氨甲环酸可显著降低TKA围手术期输血人数及患者失血量，且不增加患者深静脉血栓发生率。与静脉给药法相比，局部应用氨甲环酸在有效性及安全性方面均未见明显优势。受原始资料样本量的限制，局部应用氨甲环酸对深静脉血栓发生率的影响尚待评估，本研究尚需更多大样本量、高质量的临床研究加以验证。

Objective To systematically evaluate the effectiveness and safety of topical administration of tranexamic acid for total knee arthroplasty（TKA） in order to provide evidence for clinical application of tranexamic acid. Methods Databases including PubMed, EMbase, CENTRAL （Issue 3, 2015）, WanFang Data, CBM, CNKI were searched to collect the randomized controlled trails （RCT） about tranexamic acid for total knee arthroplasty from inception to March 2015. Two researchers independently screened the literatures, extracted the data and evaluated the quality of the methods according to the inclusion and exclusion criteria. The Meta- analysis was conducted using RevMan 5.3 software. Results A total of 16 RCT involving 1 533 patients were included, l0 RCT compared with placebo and 6 RCTs compared with intravenous usage. The results of Meta-analysis showed that： Compared with placebo, the incidence of transfusion rate had reduced[odds ratio（OR）=0.3, 95%CI（0.19-0.46）]（P〈0.01）, Total blood loss had reduced [standard mean difference （SMD）=- 1.13, 95% CI （- 1.27-- 1.00）]（P〈0.01）. However, compared with intravenous tranexamic acid,there was no significant difference in the numbers of blood transfusion during perioperative time, blood loss and incidence of deep venous thrombosis （P〉0.05）. Conclusions The topical administration of tranexamic acid is an effective and safe method of reducing the need for blood transfusion after total knee arthroplasty without increasing the incidence of deep venous thrombosis. Compared with intravenous tranexamic acid, Topical administration had no clear superiority. Due to the limited number of research, the above conclusion is still needed large volume, high aualitv trials to verified.