Zhang Pei, Liang Yuan, Chen Pengtao, Fang Yongchao, He Jinshan, Wang Jingcheng
Dalian Medical University, Dalian, Liaoning Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital, Yangzhou, Jiangsu, China.
Medicine (Baltimore). 2016 Dec;95(50):e5573. doi: 10.1097/MD.0000000000005573.
As the prevalence of total hip arthroplasty (THA) is increasing, it is usually associated with considerable blood loss. Tranexamic acid (TXA) has been reported to reduce perioperative blood loss in hip joint arthroplasty. But the best route of TXA administration continues to be controversial. So, we conducted a meta-analysis that integrated all data from the 7 included trials to compare the effectiveness and safety of topical and intravenous TXA administration in primary THA. The endpoints assessed in this meta-analysis include the comparisons of total blood loss, postoperative hemoglobin decline, transfusion rates, the incidence rate of deep vein thrombosis (DVT), pulmonary embolisms (PE), and wound infection.
Literature searches of PubMed, EMBASE, the Cochrane Library, the Chinese Biomedical Literature database, the CNKI database, and Wan Fang Data were performed up to August 30, 2016. Randomized controlled trials (RCTs) were included in our meta-analysis if they compared the efficiency and safety of intravenous versus topical administration of TXA in patients who underwent primary THA. The endpoints included the comparisons of total blood loss, postoperative hemoglobin decline, transfusion rates, the incidence rate of DVT, PE, and wound infection. A meta-analysis was performed following the guidelines of the Cochrane Reviewer's Handbook and the PRISMA statement. The pooling of data was carried out by using RevMan 5.3, Denmark.
Seven RCTs involving 964 patients met the inclusion criteria. Our meta-analysis indicated that there were no significant differences in the 2 groups in terms of total blood loss ([mean difference (MD) = -14.74, 95% confidence interval (CI): -89.21 to 59.74, P = 0.7], transfusion rates [RD = -0.02, 95% CI: -0.05 to 0.02, P = 0.39]; no significant differences were found regarding the incidence of adverse effects such as deep venous thrombosis [DVT] [RD = 0.00, 95% CI: -0.01 to 0.01, P = 1.00], PE [RD = 0.00, 95% CI: -0.01 to 0.01, P = 0.71], or wound infection [RD = -0.01, 95% CI: -0.06 to 0.04, P = 0.66]). The pooled results showed that the intravenous groups had a lower postoperative hemoglobin decline (MD = -0.47, 95% CI: -0.74 to -0.20, P = 0.0006). It was probably due to insufficient data and the varied reporting of outcomes. There was some inherent heterogeneity due to the small sample size of each primary study.
The topical and intravenous administrations of TXA have a similar effect on the decrease of blood loss without an increased risk of complications (DVT, PE, and wound infection). Intravenous TXA administration may have a maximum efficacy. Topical TXA administration may be preferred in patients who with high risk of thromboembolic events. However, larger, high-quality RCTs are required to explore the optimal regimen, dosage, timing still in the future in order to recommend TXA widespread use in total joint arthroplasty.
随着全髋关节置换术（THA）的普及率不断上升，该手术通常会伴随大量失血。据报道，氨甲环酸（TXA）可减少髋关节置换术中的围手术期失血。但TXA的最佳给药途径仍存在争议。因此，我们进行了一项荟萃分析，整合了7项纳入试验的所有数据，以比较局部和静脉注射TXA在初次THA中的有效性和安全性。该荟萃分析评估的终点包括总失血量、术后血红蛋白下降、输血率、深静脉血栓形成（DVT）、肺栓塞（PE）和伤口感染的发生率。
截至2016年8月30日，我们对PubMed、EMBASE、Cochrane图书馆、中国生物医学文献数据库、CNKI数据库和万方数据进行了文献检索。如果随机对照试验（RCT）比较了初次THA患者静脉注射与局部应用TXA的有效性和安全性，则纳入我们的荟萃分析。终点包括总失血量、术后血红蛋白下降、输血率、DVT、PE和伤口感染的发生率比较。按照Cochrane系统评价员手册和PRISMA声明的指南进行荟萃分析。使用丹麦的RevMan 5.3进行数据合并。
7项涉及964例患者的RCT符合纳入标准。我们的荟萃分析表明，两组在总失血量方面无显著差异（[平均差（MD）=-14.74，95%置信区间（CI）：-89.21至59.74，P=0.7]）、输血率方面无显著差异（[风险差（RD）=-0.02，95%CI：-0.05至0.02，P=0.39]）；在深静脉血栓形成（DVT）[RD=0.00，95%CI：-0.01至0.01，P=1.00]、PE[RD=0.00，95%CI：-0.01至0.01，P=0.71]或伤口感染[RD=-0.01，95%CI：-0.06至0.04，P=0.66]等不良反应发生率方面未发现显著差异。汇总结果显示，静脉注射组术后血红蛋白下降幅度较小（MD=-0.47，95%CI：-0.74至-0.20，P=0.0006）。这可能是由于数据不足以及结果报告的差异。由于每项原始研究的样本量较小，存在一些内在异质性。
TXA局部给药和静脉给药在减少失血量方面效果相似，且不会增加并发症（DVT、PE和伤口感染）风险。静脉注射TXA可能具有最大疗效。对于血栓栓塞事件高危患者，局部应用TXA可能更受青睐。然而，未来仍需要更大规模、高质量的RCT来探索最佳方案、剂量及给药时机，以便推荐TXA在全关节置换术中广泛应用。
