靜脈聯(lián)合局部應(yīng)用氨甲環(huán)酸對(duì)人工全髖關(guān)節(jié)置換術(shù)失血量影響

王百盛,　劉欣偉,　張敬東,　韓文鋒,　王　寧,　劉海立

沈陽(yáng)軍區(qū)總醫(yī)院 骨科 全軍重癥戰(zhàn)創(chuàng)傷救治中心，遼寧 沈陽(yáng)　110016

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靜脈聯(lián)合局部應(yīng)用氨甲環(huán)酸對(duì)人工全髖關(guān)節(jié)置換術(shù)失血量影響

王百盛,劉欣偉,張敬東,韓文鋒,王寧,劉海立

沈陽(yáng)軍區(qū)總醫(yī)院 骨科 全軍重癥戰(zhàn)創(chuàng)傷救治中心，遼寧 沈陽(yáng)110016

摘要：目的研究靜脈聯(lián)合局部應(yīng)用氨甲環(huán)酸(TXA)對(duì)初次行單側(cè)人工全髖關(guān)節(jié)置換術(shù)(THA)圍術(shù)期失血量的影響。方法選取2015年3月至2016年3月在沈陽(yáng)軍區(qū)總醫(yī)院骨科行初次單側(cè)人工THA患者122例，隨機(jī)分為靜脈聯(lián)合局部TXA組(A組)61例及對(duì)照組(B組)61例。A組術(shù)中髖臼及股骨髓腔創(chuàng)面分別應(yīng)用1.0 g(10 ml)TXA原液浸潤(rùn)，并用紗布填充髓腔止血10 s，于關(guān)閉關(guān)節(jié)腔后經(jīng)引流管關(guān)節(jié)腔內(nèi)注射2.0 g(20ml)TXA，夾閉引流管4 h后打開，術(shù)后48 h拔除引流裝置，術(shù)后6 h及24 h靜脈滴注0.5 g TXA+100 ml生理鹽水。B組靜脈聯(lián)合局部應(yīng)用相同劑量生理鹽水。觀察記錄兩組患者總失血量、術(shù)中失血量、術(shù)后24 h及72 h血紅蛋白、術(shù)后引流量、活化部分凝血酶時(shí)間、凝血酶原時(shí)間、血栓事件發(fā)生率等。結(jié)果A組患者總失血量、術(shù)后引流量均明顯少于B組，差異有統(tǒng)計(jì)學(xué)意義(P<0.05)；A組術(shù)后24 h及72 h血紅蛋白值均明顯高于B組，差異有統(tǒng)計(jì)學(xué)意義(P<0.05)；其余各項(xiàng)指標(biāo)差異均無(wú)統(tǒng)計(jì)學(xué)意義(P>0.05)。兩組患者術(shù)后均未發(fā)生血栓事件。結(jié)論術(shù)后靜脈滴注聯(lián)合術(shù)中局部應(yīng)用TXA能顯著減少初次單側(cè)人工THA患者圍術(shù)期失血量，有很好的療效和安全性，不增加術(shù)后血栓形成風(fēng)險(xiǎn)。

關(guān)鍵詞：氨甲環(huán)酸；置換；靜脈；局部；圍術(shù)期；靜脈血栓形成；失血

DOI∶10.16048/j.issn.2095-5561.2016.04.03

人工全髖關(guān)節(jié)置換術(shù)(total hip arthroplasty，THA)對(duì)于治療高齡股骨頸骨折、股骨頭壞死等疾病療效非常顯著，能夠幫助患者盡早下地進(jìn)行功能鍛煉，減少患者長(zhǎng)期臥床相關(guān)并發(fā)癥的發(fā)生率，但該手術(shù)創(chuàng)傷大，術(shù)中失血量多[1]，所以控制術(shù)中及術(shù)后的失血量尤為重要。近年來(lái)，氨甲環(huán)酸(tranexamic acid, TXA)被廣泛應(yīng)用于關(guān)節(jié)置換圍術(shù)期的血液管理[2]。本研究采用靜脈聯(lián)合局部應(yīng)用TXA在初次單側(cè)人工THA圍術(shù)期進(jìn)行止血，取得滿意療效。現(xiàn)報(bào)道如下。

1　資料與方法

1.1納入標(biāo)準(zhǔn)(1)診斷為股骨頭缺血性壞死、髖關(guān)節(jié)骨關(guān)節(jié)炎需行Ⅰ期單側(cè)人工THA；(2)假體均為強(qiáng)生公司pinnacle生物全髖關(guān)節(jié)(全陶)假體；(3)術(shù)前凝血功能、血紅蛋白、紅細(xì)胞比容均正常者；(4)既往未行任何髖部手術(shù)；(5)獲得倫理委員會(huì)批準(zhǔn)，患者及其家屬已簽署知情同意書，同意參加本次研究。

1.2排除標(biāo)準(zhǔn)(1)患者患有凝血障功能礙，合并其他血液系統(tǒng)疾病或者血紅蛋白<90 g/L；(2)美國(guó)麻醉協(xié)會(huì)麻醉評(píng)分>3分；(3)患有嚴(yán)重心、肺、肝、腎功能不全；(4)既往有血栓、腦梗病史者；(5)患有惡性腫瘤患者；(6)伴有身體任何部位活動(dòng)性感染患者；(7)對(duì)TXA過(guò)敏者。

1.3一般資料納入研究患者122例，按照隨機(jī)數(shù)字表法分為兩組，靜脈聯(lián)合局部TXA組(A組)61例及對(duì)照組(B組)61例。兩組患者在年齡、性別、體質(zhì)量指數(shù)、病種類別：骨關(guān)節(jié)炎/股骨頭缺血性壞死(OA/AVN)、術(shù)前凝血酶原時(shí)間(PT)、術(shù)前活化部分凝血酶時(shí)間(APTT)、術(shù)前血紅蛋白(Hb)方面比較，差異均無(wú)統(tǒng)計(jì)學(xué)意義(P>0.05)，具有可比性(表1)。

表1　兩組患者一般資料比較±s)

1.2手術(shù)方法兩組患者全部采用全身麻醉，全部手術(shù)由同一組醫(yī)師完成，均采用后外側(cè)切口入路，平均手術(shù)時(shí)間從切開皮膚至縫合皮膚計(jì)算，髖關(guān)節(jié)假體均為強(qiáng)生公司pinnacle生物全髖關(guān)節(jié)(全陶)假體，采用常規(guī)術(shù)式進(jìn)行手術(shù)。術(shù)后夾閉引流管4 h后打開，術(shù)后48 h拔除引流裝置，并記錄引流量。A組術(shù)中分別應(yīng)用1.0 g(10 ml)TXA原液浸潤(rùn)髖臼及股骨髓腔創(chuàng)面，并用紗布填充髓腔止血10 s，于關(guān)閉關(guān)節(jié)腔后經(jīng)引流管向關(guān)節(jié)腔內(nèi)注射2.0 g(20 ml)TXA，術(shù)后6 h及24 h靜脈滴注0.5 g TXA+100 ml生理鹽水；B組靜脈聯(lián)合局部應(yīng)用相同劑量生理鹽水。

1.3圍術(shù)期治療術(shù)后12 h給予抗凝藥物利伐沙班10 mg口服，1片/d，至術(shù)后4周。術(shù)后由主管醫(yī)師指導(dǎo)行踝泵、股四頭肌等長(zhǎng)收縮等練習(xí)，鍛煉肌肉功能并減少下肢血栓發(fā)生率，同時(shí)告知患者術(shù)后相關(guān)注意事項(xiàng)。術(shù)后12 h開始使用足底靜脈泵，每次使用30 min，2次/d，以達(dá)到預(yù)防下肢深靜脈血栓的目的。術(shù)后常規(guī)換藥、拔管均由同一主治醫(yī)師負(fù)責(zé)。術(shù)后第2天行髖關(guān)節(jié)正側(cè)位X線檢查，如無(wú)異常，指導(dǎo)患者下床行走。術(shù)后5 d和1個(gè)月復(fù)查下肢動(dòng)靜脈血管彩超，記錄報(bào)告結(jié)果。

1.4失血量計(jì)算按照Nadler等[3]提供的公式計(jì)算患者血容量(PBV)。

PBV=K1×身高(m3)+K2×質(zhì)量(kg)+K3

男性患者K1=0.366 9，K2=0.032 19，K3=0.604 1；女性患者K1=0.356 1，K2=0.033 08，K3=0.183 3。

紅細(xì)胞丟失量= PBV×(術(shù)前紅細(xì)胞比容-紅細(xì)胞比容最低值)

患者總失血量=總紅細(xì)胞丟失量/術(shù)前紅細(xì)胞比容

兩組患者術(shù)中、術(shù)后均未輸血。

2　結(jié)果

2.1兩組患者術(shù)后總失血量、術(shù)中失血量、術(shù)后引流量及術(shù)后血紅蛋白比較A組患者術(shù)后總失血量、術(shù)后引流量均明顯少于B組，差異有統(tǒng)計(jì)學(xué)意義(P<0.05)；兩組患者術(shù)中出血量比較，差異無(wú)統(tǒng)計(jì)學(xué)意義(P>0.05)；A組患者術(shù)后24 h及72 h血紅蛋白值均明顯高于B組，差異有統(tǒng)計(jì)學(xué)意義(P<0.05)。見表2。

表1　兩組患者術(shù)后總失血量、術(shù)中失血量、術(shù)后引流量及術(shù)后24、72 h血紅蛋白比較±s)

2.2兩組患者術(shù)后24 h活化部分凝血酶時(shí)間、凝血酶原時(shí)間比較兩組患者術(shù)后24 h活化部分凝血酶時(shí)間、凝血酶原時(shí)間比較，差異均無(wú)統(tǒng)計(jì)學(xué)意義(P>0.05)。見表3。

表3　兩組患者術(shù)后24 h活化部分凝血酶時(shí)間、凝血酶原時(shí)間比較±s)

2.3兩組患者發(fā)生血栓事件比較 兩組患者術(shù)中、術(shù)后均未發(fā)生血栓事件。

3　討論

人工THA是目前治療高齡股骨頸骨折、先天性髖關(guān)節(jié)發(fā)育不良等疾病的有效措施，年手術(shù)量不斷增長(zhǎng)[4]。人工THA造成的創(chuàng)傷大，手術(shù)激活纖溶亢進(jìn)系統(tǒng)，且術(shù)中股骨截骨、股骨腔擴(kuò)髓和髖臼側(cè)打磨等均會(huì)造成患者術(shù)中術(shù)后大量失血。Rosencher等[5]的歐洲多中心調(diào)查顯示,初次行單側(cè)人工THA的患者圍術(shù)期失血量約為1 944 ml。圍術(shù)期失血量過(guò)多會(huì)造成患者貧血,且術(shù)后重度貧血會(huì)增加關(guān)節(jié)內(nèi)感染風(fēng)險(xiǎn)，延長(zhǎng)康復(fù)時(shí)間,甚至?xí)黾踊颊咚劳雎蔥6]。目前人工THA圍術(shù)期的異體輸血率較高,Hart等[7]分析了2011年美國(guó)骨科的統(tǒng)計(jì)數(shù)據(jù),統(tǒng)計(jì)了9 362例接受初次單側(cè)人工THA的患者，其中有22.2%的患者接受異體輸血。異體輸血存在醫(yī)源性感染、輸血反應(yīng)等風(fēng)險(xiǎn)，且會(huì)增加患者的住院費(fèi)用，增加患者的家庭負(fù)擔(dān)[8-9]。因此，降低人工THA患者術(shù)中術(shù)后失血量至關(guān)重要。目前，自體血回輸、神經(jīng)阻滯麻醉及TXA的應(yīng)用等方法被用于人工THA中[10-12]，以減少手術(shù)失血量、降低患者輸血率，其中TXA的使用效果顯著[13]。

TXA是賴氨酸合成的衍生物，與賴氨酸結(jié)合位點(diǎn)的親和力極強(qiáng)，能夠競(jìng)爭(zhēng)性抑制纖維蛋白溶解酶的活性，從而減少纖維蛋白的降解，達(dá)到止血的目的，并且不增加圍術(shù)期血栓事件的發(fā)生率[14-15]。Poeran等[16]通過(guò)對(duì)872 416例全髖或全膝關(guān)節(jié)置換的患者進(jìn)行回顧性研究發(fā)現(xiàn)，使用TXA不僅不會(huì)增加圍術(shù)期血栓的形成，而且能在一定程度上降低血栓形成風(fēng)險(xiǎn)。Patel等[17]研究發(fā)現(xiàn)，靜脈或局部應(yīng)用TXA都可以減少人工THA圍術(shù)期的失血量。靜脈滴注TXA作用范圍廣，抑制因手術(shù)激活的機(jī)體纖溶亢進(jìn)，從而顯著減少了THA圍術(shù)期的失血量；手術(shù)部位局部浸潤(rùn)TXA可靶向作用于創(chuàng)面，全身吸收較少，同樣可以減少術(shù)中、術(shù)后的出血。本研究結(jié)果顯示，A組患者總失血量、術(shù)后引流量均明顯少于B組，差異有統(tǒng)計(jì)學(xué)意義(P<0.05)；A組術(shù)后24、72 h血紅蛋白均明顯高于B組，差異有統(tǒng)計(jì)學(xué)意義(P<0.05)。本研究認(rèn)為靜脈與局部聯(lián)合應(yīng)用TXA可把兩者的優(yōu)勢(shì)相結(jié)合，既可顯著減少THA術(shù)中出血量，降低輸血率，又可有效減少全身纖溶反應(yīng)，從而達(dá)到止血目的。

綜上所述，靜脈聯(lián)合局部應(yīng)用TXA能顯著減少初次單側(cè)人工THA圍術(shù)期的失血量，并且在全部應(yīng)用TXA的患者中均未發(fā)生靜脈血栓事件。此外，該藥品的價(jià)效比高，給藥途徑方便。所以，靜脈聯(lián)合局部應(yīng)用TXA值得推廣臨床使用。

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基金項(xiàng)目：社會(huì)發(fā)展攻關(guān)計(jì)劃(2013225089)

通信作者：張敬東，E-mail：87527670@163.com

文章編號(hào)：2095-5561(2016)04-0200-04 中圖分類號(hào)：R687.3

文獻(xiàn)標(biāo)志碼：A

收稿日期：2016-06-05

Combined intravenous and topical application of tranexamic acid in the perioperative application of artificial total hip arthroplasty

WANG Bai-sheng,LIU Xin-wei,ZHANG Jing-dong,HAN Wen-feng,WANG Ning,LIU Hai-li

(Department of Orthopedics,The General Hospital of Shenyang Military Command,Shenyang 110016,China)

Abstract：ObjectiveTo explore the observation of combined intravenous and topical application of tranexamic acid on primary unilateral artificial total hip arthroplasty(THA) perioperative blood loss effect.MethodsA retrospective study was performed on 122 cases of patients that received primary unilateral artificial THA in the General Hospital of Shenyang Military Command from March 2015 to March 2016.Patients were randomly divided into the combined intravenous and topical TXA group(Group A) and the control group(Group B),with 61 cases in each group.Patients in group A that underwent acetabular and femoral medullary cavity of wound were used 1.0g(10 ml) ammonia TXA liquid infiltration,and medullary cavity hemostatic 10 seconds was filled with gauze,articular cavity after the closure of the drainage tube to the intra-articular injection of 2.0g(20 ml) TXA and clamping of the drainage tube 4 hours after opening,after 48 hours were pulled in drainage device,postoperative 6 hours and postoperative 24 hours intravenous injection 0.5g ammonium TXA with 100 ml of physiological saline.In Group B,combined intravenous and topical application of the same dose of saline.The two groups of patients with total blood loss,intraoperative blood loss,postoperative 24 hours and 72 hours Hb,APTT,PT and thromboembolic events occur rate were observed and recorded.ResultsThe bleeding volume during operation,drainage volume in Group A were significantly less than those in Group B,the differences were statistically significant(P<0.05);the postoperative 24 hours and 72 hours hemoglobin values of group A were significantly higher than those of group B,the differences were statistically significant(P<0.05);the differences of other indexes had no statistical significance(P>0.05).No thrombosis events occurred in the two groups after operation.ConclusionPostoperative intravenous drip combined with in topical application of TXA can significantly reduce the primary unilateral artificial THA in patients with perioperative blood loss,good efficacy and safety,does not increase the risk of postoperative thrombosis.

Key words:Tranexamic acid;Arthroplasty;Intravenous;Topical;Perioperative；Venous thrombosis；Blood loss

第一作者：王百盛(1992-)，男，遼寧大連人，醫(yī)師，碩士