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  

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

作　　者：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] 

机构地区：[1]滕州市中心人民医院关节外科,山东省滕州市277500 [2]滕州市中心人民医院肿瘤二科,山东省滕州市277500

出　　处：《中国组织工程研究》2017年第15期2314-2319,共6页Chinese Journal of Tissue Engineering Research

基　　金：济宁医学院2015年度校级科研计划项目(JY2015KJ042)~~

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 m L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 m L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。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＆#39;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＆#39;s Hospital of China, approval num

关 键 词：组织工程 氨甲环酸 髋关节 骨科植入物 人工假体 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 

分 类 号：R318[医药卫生—生物医学工程]