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
发布时间：2018-08-16 14:42
【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。
[Abstract]:Background: intravenous application of total hip arthroplasty and intraarticular injection of carbamoic acid can significantly reduce perioperative blood loss, blood transfusion volume and blood transfusion rate, but the difference between the two methods is not clear. Aim: to observe the effect of two different methods of methacylic acid on blood loss in perioperative period of total hip replacement (THR). Methods: a prospective, single center, open, randomized controlled clinical trial was conducted at the Central people's Hospital of Tengzhou City, Shandong Province, China. Ninety patients with unilateral total hip replacement were randomly divided into 3 groups. 30 patients were treated with methocyclic acid intravenous therapy. At the beginning of the replacement, 15 mg/kg of methacylic acid was diluted into 100ml normal saline by intravenous drip. 20 mL saline was injected into the articular cavity after deep fascia suture, 30 cases were injected with 100 mL saline at the beginning of replacement, and 1.5 g of aminocyclylic acid and 20 mL of normal saline were injected into the articular cavity after deep fascia suture. In the control group, 100ml saline was given intravenously at the beginning of replacement, and 20 mL saline was injected into the articular cavity after deep fascia suture. The main observation index of the experiment was recessive blood loss 1 ~ 3 days after replacement, the secondary observation index of the experiment was intraoperative, the dominant blood loss, the blood transfusion rate and the average transfusion volume were 1 ~ 3 days after replacement. The other indexes were the incidence of adverse reactions and complications in 3 months after replacement. The test was approved by the Ethics Committee of the Central people's Hospital of Tengzhou City, Shandong Province, China (2015-026). The study meets the requirements of the Helsinki Declaration formulated by the World Medical Association. Participants themselves have informed consent and signed informed consent to the treatment plan and procedure. Discussion: the trial was designed in April 2015, began collecting cases in July 2015, and completed all data analysis in December 2017. The purpose of the study was to investigate the effect of intraarticular injection and intravenous application of ammonia on blood loss in perioperative period of total hip replacement (THR), so as to determine which medication is more effective and to provide a more effective way for total hip replacement (THR).
【作者单位】： 滕州市中心人民医院关节外科;滕州市中心人民医院肿瘤二科;
【基金】：济宁医学院2015年度校级科研计划项目(JY2015KJ042)~~
【分类号】：R687.4
[Abstract]:Background: intravenous application of total hip arthroplasty and intraarticular injection of carbamoic acid can significantly reduce perioperative blood loss, blood transfusion volume and blood transfusion rate, but the difference between the two methods is not clear. Aim: to observe the effect of two different methods of methacylic acid on blood loss in perioperative period of total hip replacement (THR). Methods: a prospective, single center, open, randomized controlled clinical trial was conducted at the Central people's Hospital of Tengzhou City, Shandong Province, China. Ninety patients with unilateral total hip replacement were randomly divided into 3 groups. 30 patients were treated with methocyclic acid intravenous therapy. At the beginning of the replacement, 15 mg/kg of methacylic acid was diluted into 100ml normal saline by intravenous drip. 20 mL saline was injected into the articular cavity after deep fascia suture, 30 cases were injected with 100 mL saline at the beginning of replacement, and 1.5 g of aminocyclylic acid and 20 mL of normal saline were injected into the articular cavity after deep fascia suture. In the control group, 100ml saline was given intravenously at the beginning of replacement, and 20 mL saline was injected into the articular cavity after deep fascia suture. The main observation index of the experiment was recessive blood loss 1 ~ 3 days after replacement, the secondary observation index of the experiment was intraoperative, the dominant blood loss, the blood transfusion rate and the average transfusion volume were 1 ~ 3 days after replacement. The other indexes were the incidence of adverse reactions and complications in 3 months after replacement. The test was approved by the Ethics Committee of the Central people's Hospital of Tengzhou City, Shandong Province, China (2015-026). The study meets the requirements of the Helsinki Declaration formulated by the World Medical Association. Participants themselves have informed consent and signed informed consent to the treatment plan and procedure. Discussion: the trial was designed in April 2015, began collecting cases in July 2015, and completed all data analysis in December 2017. The purpose of the study was to investigate the effect of intraarticular injection and intravenous application of ammonia on blood loss in perioperative period of total hip replacement (THR), so as to determine which medication is more effective and to provide a more effective way for total hip replacement (THR).
【作者单位】： 滕州市中心人民医院关节外科;滕州市中心人民医院肿瘤二科;
【基金】：济宁医学院2015年度校级科研计划项目(JY2015KJ042)~~
【分类号】：R687.4
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1 陈艰;氨甲环酸在体外循环心脏手术中的应用[J];江苏医药;1997年03期
2 赵e鹒，
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