术后口服氨甲环酸在全髋关节置换术中的安全性和有效性研究The effectiveness and safety of oral tranexamic acid after total hip arthroplasty: a randomized controlled trial
曹国瑞;张少云;黄强;徐彬;谢锦伟;岳辰;陈果;裴福兴;
摘要(Abstract):
[目的]在加速康复流程下,以连续多次静脉应用氨甲环酸(TXA)的患者作为对照,探究术后口服TXA在初次单侧全髋关节置换术(THA)围术期的安全性和有效性。[方法]前瞻性纳入2016年10月~2017年1月于四川大学华西医院关节外科中心行初次单侧THA的患者61例,随机分为试验组(30例,术前5~10 min静滴TXA 20ml/kg,第一剂后3 h静滴浓度1%的TXA 1 g,第一剂后6、12及24 h各口服TXA 1 g)和对照组(31例,术前5~10 min静滴TXA 20 ml/kg,第一剂后3、6、12及24 h静滴浓度1%的TXA 1 g),比较两组患者的围术期失血量(隐性失血量、总失血量、血红蛋白变化量和异体输血率)、炎性指标(C反应蛋白和白细胞介素-6)、纤溶指标[D-二聚体和纤维蛋白(原)降解产物]及术后并发症。[结果]两组患者的围术期失血量,术后6、24、48 h,术后14 d的炎性指标和纤溶指标水平的差异均无统计学意义。试验组和对照组分别有2例和3例发生肌间静脉血栓,差异无统计学意义。两组患者均没有发生肺栓塞和伤口并发症。[结论]在加速康复流程下,术后口服与多次重复静脉应用TXA拥有同样的效果,可减少患者的围术期失血量,降低异体输血率,缩短术后住院时间,同时抑制炎症反应和纤溶过程,且不增加并发症的发生率。
关键词(KeyWords): 氨甲环酸;全髋关节置换术;纤溶指标;炎性指标
基金项目(Foundation): 卫生部2013年度卫生行业科研专项(编号:2013020007)
作者(Author): 曹国瑞;张少云;黄强;徐彬;谢锦伟;岳辰;陈果;裴福兴;
Email:
DOI:
参考文献(References):
- [1]Bierbaum BE,Callaghan JJ,Galante JO,et al.An analysis of blood management in patients having a total hip or knee arthroplasty[J].J Bone Joint Surg Am,1999,81(1):2-10.
- [2]Loftus TJ,Spratling L,Stone BA,et al.A patient blood management program in prosthetic joint arthroplasty decreases blood use and improves outcomes[J].J Arthroplasty,2016,31(1):11-14.
- [3]Rosencher N,Kerkkamp HE,Macheras G,et al.Orthopedic surgery transfusion hemoglobin european overview(OSTHEO)study:blood management in elective knee and hip arthroplasty in europe[J].Transfusion,2003,43(4):459-469.
- [4]Di Blasi JF,Smith RP,Garavaglia J,et al.Comparing cost,efficacy,and safety of intravenous and topical tranexamic acid in total hip and knee arthroplasty[J].Am J Orthop(Belle Mead NJ),2016,45(7):439-443.
- [5]Li JF,Li H,Zhao H,et al.Combined use of intravenous and topical versus intravenous tranexamic acid in primary total knee and hip arthroplasty:a meta-analysis of randomised controlled trials[J].J Orthop Surg Res,2017,12(1):22.
- [6]Yue C,Kang P,Yang P,et al.Topical application of tranexamic acid in primary total hip arthroplasty:a randomized double-blind controlled trial[J].J Arthroplasty,2014,29(12):2452-2456.
- [7]Malhotra R,Kumar V,Garg B.The use of tranexamic acid to reduce blood loss in primary cementless total hip arthroplasty[J].Eur J Orthop Surg Traumatol,2011,21(2):101-104.
- [8]张杭州,白希壮,梁庆威,等.全髋关节置换术中使用氨甲环酸的有效性及安全性研究[J].中国医科大学学报,2016,45(10):887-890.
- [9]Konig G,Hamlin BR,Waters JH.Topical tranexamic acid reduces blood loss and transfusion rates in total hip and total knee arthroplasty[J].J Arthroplasty,2013,28(9):1473-1476.
- [10]Xie J,Ma J,Yao H,et al.Multiple boluses of intravenous tranexamic acid to reduce hidden blood loss after primary total knee arthroplasty without tourniquet:a randomized clinical trial[J].J Arthroplasty,2016,31(11):2458-2464.
- [11]谢锦伟,蔡迎春,马俊,等.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[J].中国矫形外科杂志,2016,24(3):230-235.
- [12]姚欢,谢锦伟,岳辰,等.多次重复静脉应用氨甲环酸减少初次全髋关节置换术失血有效性与安全性的前瞻性对照研究[J].中国骨与关节杂志,2016,5(12):885-890.
- [13]周宗科,翁习生,曲铁兵,等.中国髋、膝关节置换术加速康复--围术期管理策略专家共识[J].中华骨与关节外科杂志,2016,9(1):1-9.
- [14]岳辰,周宗科,裴福兴,等.中国髋、膝关节置换术围术期抗纤溶药序贯抗凝血药应用方案的专家共识[J].中华骨与关节外科杂志,2015,8(4):281-285.
- [15]中华医学会骨科学分会.中国骨科大手术静脉血栓栓塞症预防指南[J].中华骨科杂志,2016(2):65-71.
- [16]Sharrock NE,Go G,Harpel PC,et al.Thrombogenesis during total hip-arthroplasty[J].Clin Orthop,1995,3(19):16-27.
- [17]谢锦伟,姚欢,岳辰,等.初次髋、膝关节置换术后纤溶变化[J].中国矫形外科杂志,2016,24(10):931-936.
- [18]Irwin A,Khan SK,Jameson SS,et al.Oral versus intravenous tranexamic acid in enhanced-recovery primary total hip and knee replacement:results of 3000 procedures[J].Bone Joint J,2013,95-b(11):1556-1561.
- [19]Pilbrant A,Schannong M,Vessman J.Pharmacokinetics and bioavailability of tranexamic acid[J].Eur J Clin Pharmacology,1981,20(1):65-72.
- [20]Zohar E,Ellis M,Ifrach N,et al.The postoperative blood-sparing efficacy of oral versus intravenous tranexamic acid after total knee replacement[J].Anesth Analg,2004,99(6):1679-1683
- [21]Fillingham YA,Kayupov E,Plummer DR,et al.The james a.rand young investigator's award:a randomized controlled trial of oral and intravenous tranexamic acid in total knee arthroplasty:the same efficacy at lower cost[J].J Arthroplasty,2016,31(9 Suppl):26-30.
- [22]Alipour M,Tabari M,Keramati M,et al.Effectiveness of oral tranexamic acid administration on blood loss after knee artroplasty:a randomized clinical trial[J].Transfus Apher Sci,2013,49(3):574-577.
- [23]Cankaya D,Dasar U,Satilmis AB,et al.The combined use of oral and topical tranexamic acid is a safe,efficient and low-cost method in reducing blood loss and transfusion rates in total knee arthroplasty[J].J Orthop Surg(Hong Kong),2017,25(1):2309499016684725.
- [24]Padhi S,Bullock I,Li L,et al.Intravenous fluid therapy for adults in hospital:summary of NICE guidance[J].BMJ,2013,347:7073.