中国组织工程研究

中国组织工程研究 ›› 2017, Vol. 21 ›› Issue (15): 2314-2319.doi: 10.3969/j.issn.2095-4344.2017.15.004

• 人工假体 artificial prosthesis • 上一篇    下一篇

氨甲环酸两种不同用药方式对全髋关节置换围手术期失血量的影响：前瞻性、开放性、随机对照临床试验

侯振扬1，孙义玲2，庞 涛1，吕 东1，朱 彪1，李 振1，柴星宇1，许正文1，苏长征1   

  1. 滕州市中心人民医院，1关节外科，2肿瘤二科，山东省滕州市  277500
  • 出版日期:2017-05-28 发布日期:2017-06-07
  • 通讯作者: 苏长征，副主任医师，滕州市中心人民医院关节外科，山东省滕州市 277500
  • 作者简介:侯振扬，男，1983年生，汉族，2011年苏州大学毕业，硕士，临床医学在读博士。
  • 基金资助:

    济宁医学院2015年度校级科研计划项目(JY2015KJ042)

Effects of two different tranexamic acid administration methods on perioperative blood loss in total hip arthroplasty: study protocol for a prospective, open-label, randomized, controlled clinical trial

Hou Zhen-yang1, Sun Yi-ling2, Pang Tao1, Lv Dong1, Zhu Biao1, Li Zhen1, Chai Xing-yu1, Xu Zheng-wen1,Su Chang-zheng1   

  1. 1Department of Joint Surgery, 2Second Department of Tumor, Tengzhou Central People’s Hospital, Tengzhou 277500, Shandong Province, China
  • Online:2017-05-28 Published:2017-06-07
  • Contact: Su Chang-zheng, Associate chief physician, Department of Joint Surgery, Tengzhou Central People’s Hospital, Tengzhou 277500, Shandong Province, China
  • About author:Hou Zhen-yang, Studying for doctorate, Department of Joint Surgery, Tengzhou Central People’s Hospital, Tengzhou 277500, Shandong Province, China
  • Supported by:

    the Scientific Research Project of Jining Medical University of China in 2015, No. JY2015KJ042

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摘要：

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文题释义：
氨甲环酸：主要用于急性或慢性、局限性或全身性纤维蛋白溶解亢进所致的各种出血。
显性失血量：包括术中失血量及置换后失血量。术中失血量为负压吸引器液体量减去冲洗用水量加上纱布净增重量。置换后失血量包括伤口引流量加上纱布棉垫的净增质量。
 
摘要
背景：全髋关节置换中静脉应用和关节腔内注射氨甲环酸能够明显减少患者围手术期失血量、输血量以及输血率，但两种方法的差异尚不明确。
目的：试验观察了氨甲环酸两种不同用药方式对全髋关节置换围手术期失血量的影响。
方法：研究为前瞻性、单中心、开放性、随机对照临床试验，在中国山东省滕州市中心人民医院完成。纳入单侧全髋关节置换的患者90例，随机分为3组，氨甲环酸静脉应用组30例，于置换开始时将15 mg/kg氨甲环酸稀释于100 mL生理盐水中静滴，缝合深筋膜后关节腔内注射生理盐水20 mL；氨甲环酸关节腔内注射组30例，置换开始时予100 mL生理盐水静滴，缝合深筋膜后关节腔内注射氨甲环酸1.5 g与20 mL生理盐水混合液；对照组：置换开始时予100 mL生理盐水静滴，缝合深筋膜后关节腔内注射生理盐水20 mL。试验的主要观察指标为置换后1，3 d隐性失血量；试验的次要观察指标为术中、置换后1，3 d显性失血量、输血率和平均输血量；其他观察指标为以置换后3个月不良反应发生率变化评价及并发症发生情况。试验经中国山东省滕州市中心人民医院伦理委员会批准(2015-026)。研究符合世界医学会制定的《赫尔辛基宣言》的要求。参与者本人对治疗方案和过程均知情同意，并签署知情同意书。
讨论：试验于2015年4月设计，2015年7月开始收集病例，2017年12月完成全部数据分析。试验旨在探讨氨甲环酸静脉应用和关节腔内注射对全髋关节置换围手术期失血量的影响，以确定何种用药方式更加有效，进而为全髋关节置换提供更有效的氨甲环酸使用方式。

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程
ORCID: 0000-0001-5470-0481(苏长征)

关键词: 骨科植入物, 人工假体, 氨甲环酸, 静脉应用, 关节腔注射, 人工髋关节置换, 围手术期, 失血量, 临床试验, 组织工程

Abstract:

BACKGROUND: Reducing perioperative blood loss in total hip arthroplasty is a hot topic for joint surgeons. Both intravenous infusion and intra-articular injection of tranexamic acid significantly reduce perioperative blood loss, blood transfusion volume, and need for blood transfusion in patients undergoing total hip arthroplasty. However, differences between the intravenous and intra-articular methods are not clear.

OBJECTIVE: To evaluate the effects of these two tranexamic acid administration methods on perioperative blood loss in patients undergoing total hip arthroplasty.
METHODS: We are conducting a prospective, single-center, open-label, randomized, controlled clinical trial at the Tengzhou Central People’s Hospital, China. Ninety patients undergoing unilateral total hip arthroplasty have been randomized into three groups. In the intravenous infusion group (n=30), 15 mg/kg tranexamic acid diluted in 100 mL physiological saline was infused intravenously at the beginning of surgery and 20 mL of physiological saline was injected intra-articularly after deep fascia suturing. In the intra-articular injection group (n=30), 100 mL of physiological saline was infused intravenously at the beginning of surgery and a mixture of 1.5 g tranexamic acid and 20 mL physiological saline was injected intra-articularly after deep fascia suturing. In the control group (n=30), 100 mL of physiological saline was infused intravenously at the beginning of surgery and 20 mL of physiological saline was injected intra-articularly after deep fascia suturing. The primary outcome is hidden blood loss at 1 and 3 days postoperatively. The secondary outcomes are visible blood loss, need for blood transfusion, and mean blood transfusion volume intraoperatively and on days 1 and 3 postoperatively. Other outcomes are the incidence of adverse reactions and complications within 3 months of surgery. The study protocol has been approved by the Ethics Committee of Tengzhou Central People’s Hospital of China, approval number 2015-026. All protocols will be performed in accordance with the Ethical Principles for Medical Research Involving Human Subjects in the Declaration of Helsinki. Written informed consent was provided by each patient and their family members after they indicated that they fully understood the treatment plan.
DISCUSSION: This trial was designed in April 2015. Cases were collected in July 2015. Data analysis will be finished in December 2017. This study is designed to investigate the effects of intravenous infusion versus intra-articular injection of tranexamic acid on perioperative blood loss in patients undergoing total hip arthroplasty to determine the more effective mode of administration.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Tissue Engineering, Tranexamic Acid, Hip Joint

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