【摘要】：背景:全髖關(guān)節(jié)置換中靜脈應(yīng)用和關(guān)節(jié)腔內(nèi)注射氨甲環(huán)酸能夠明顯減少患者圍手術(shù)期失血量、輸血量以及輸血率,但兩種方法的差異尚不明確。目的:試驗(yàn)觀察了氨甲環(huán)酸兩種不同用藥方式對(duì)全髖關(guān)節(jié)置換圍手術(shù)期失血量的影響。方法:研究為前瞻性、單中心、開(kāi)放性、隨機(jī)對(duì)照臨床試驗(yàn),在中國(guó)山東省滕州市中心人民醫(yī)院完成。納入單側(cè)全髖關(guān)節(jié)置換的患者90例,隨機(jī)分為3組,氨甲環(huán)酸靜脈應(yīng)用組30例,于置換開(kāi)始時(shí)將15 mg/kg氨甲環(huán)酸稀釋于100 m L生理鹽水中靜滴,縫合深筋膜后關(guān)節(jié)腔內(nèi)注射生理鹽水20 mL;氨甲環(huán)酸關(guān)節(jié)腔內(nèi)注射組30例,置換開(kāi)始時(shí)予100 mL生理鹽水靜滴,縫合深筋膜后關(guān)節(jié)腔內(nèi)注射氨甲環(huán)酸1.5 g與20 mL生理鹽水混合液;對(duì)照組:置換開(kāi)始時(shí)予100 m L生理鹽水靜滴,縫合深筋膜后關(guān)節(jié)腔內(nèi)注射生理鹽水20 mL。試驗(yàn)的主要觀察指標(biāo)為置換后1,3 d隱性失血量;試驗(yàn)的次要觀察指標(biāo)為術(shù)中、置換后1,3 d顯性失血量、輸血率和平均輸血量;其他觀察指標(biāo)為以置換后3個(gè)月不良反應(yīng)發(fā)生率變化評(píng)價(jià)及并發(fā)癥發(fā)生情況。試驗(yàn)經(jīng)中國(guó)山東省滕州市中心人民醫(yī)院倫理委員會(huì)批準(zhǔn)(2015-026)。研究符合世界醫(yī)學(xué)會(huì)制定的《赫爾辛基宣言》的要求。參與者本人對(duì)治療方案和過(guò)程均知情同意,并簽署知情同意書(shū)。討論:試驗(yàn)于2015年4月設(shè)計(jì),2015年7月開(kāi)始收集病例,2017年12月完成全部數(shù)據(jù)分析。試驗(yàn)旨在探討氨甲環(huán)酸靜脈應(yīng)用和關(guān)節(jié)腔內(nèi)注射對(duì)全髖關(guān)節(jié)置換圍手術(shù)期失血量的影響,以確定何種用藥方式更加有效,進(jìn)而為全髖關(guān)節(jié)置換提供更有效的氨甲環(huán)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).
【作者單位】： 滕州市中心人民醫(yī)院關(guān)節(jié)外科;滕州市中心人民醫(yī)院腫瘤二科;
【基金】：濟(jì)寧醫(yī)學(xué)院2015年度校級(jí)科研計(jì)劃項(xiàng)目(JY2015KJ042)~~
【分類號(hào)】：R687.4

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1 陳艱;氨甲環(huán)酸在體外循環(huán)心臟手術(shù)中的應(yīng)用[J];江蘇醫(yī)藥;1997年03期

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