抗纤溶序贯抗凝平衡预防初次THA术后VTE的单中心大样本连续病例观察性研究

The effect and balance of anti-coagulation sequential anti-fibrinolysis on VTE and transfusion following primary THA:a large,single center,prospective observational study of consecutive cases

[目的]单中心大样本连续病例观察性研究旨在探讨初次全髋关节置换术中使用氨甲环酸对术后静脉血栓栓塞症的影响及THA围手术期抗纤溶与抗凝平衡的初步临床疗效。[方法]基于国家卫生行业数据库平台，前瞻性收集本中心行初次单侧全髋关节置换术患者的基本资料，纳入患者围手术期静脉或静脉联合局部使用氨甲环酸抗纤溶，术后6h开始序贯使用低分子肝素或利伐沙班抗凝。主要观察指标为血栓发生情况及术后30d全因死亡人数；次要指标为输血率；同时根据氨甲环酸使用方式进行亚组分析。[结果]2012—2014年，共纳入本中心初次单侧全髋关节置换术患者3043例。共有199例（6．54％）发生术后血栓栓塞事件，其中肌间静脉血栓183例（6．01％），非症状性深静脉血栓16例（0．53％），无发生症状性深静脉血栓、肺栓塞及死亡患者；186例（6．1％）患者接受输血。亚组分析结果提示静脉联合局部使用氨甲环酸较单纯静脉使用术后输血率更低（5．4％Vs7．2％），差异有统计学意义（P=0．039）；深静脉血栓的发生率并没有增加（0．6％Vs0．4％，P=0．578）。[结论]THA围手术期使用TXA抗纤溶后，序贯抗凝维持两者平衡，可安全的减少围手术期输血率。

[ Objective] This large, single center, prospective observational study of consecutive cases aimed to investi- gate the epidemiology of vascular occlusive events associated with TXA following primary THA and introduce the preliminary clin- ical results of anti - coagulation sequential anti - fibrinolysis. [ Methods] We prospectively collected patients＇ data of our insti- tution through National Health Database. All the eligible patients were operated with intravenous TXA or IV combined with topical TXA administration. And sequential anti - coagulation was started 6 hour postoperatively with LMWH or Rivaroxaban. The prima- ry observation indicators were the incidence of venous thromboembolism and mortality within 30 days foUowing primary THA. Secondary indicator was transfusion rate. Subgroup analysis was performed on the basis of TXA administration methods. [ Results] During 2012 to 2014, a total of 3043 unilateral THA procedures were conducted in our institution. 199 vascular oc- clusive events occurred. The frequency of calf muscle vein thrombosis was the largest 6.01% （ 183/3 043 ） , followed by asymp- tomatic DVT 0. 53% （ 16/3 043） . No episode of symptomatic DVT, symptomatic PE and all - cause mortality within 30 days postoperatively occurred. Subgroup analysis revealed lower transfusion rate with use of combined TXA administration （5.4% Vs 7.2%, P =0. 039） . And no significant difference was detected with regard to the incidence of DVT （0. 6% Vs 0. 4%, P = 0. 578） . [ Conclusion] This study indicated that anti - coagulation sequential anti - fibrinolysist to maintain its balance, is safe and efficient to reduce perioperative blood transfusion rate following primary unilateral THA.