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        雞尾酒療法對(duì)初次全膝關(guān)節(jié)置換術(shù)后失血量的影響及安全性評(píng)價(jià)

        2018-06-20 09:24:14畢春強(qiáng)溫建民張輝楊大偉宋雪李多多
        關(guān)鍵詞:止血全膝關(guān)節(jié)置換術(shù)氨甲環(huán)酸

        畢春強(qiáng) 溫建民 張輝 楊大偉 宋雪 李多多

        [摘要] 目的 探討雞尾酒療法關(guān)節(jié)囊周?chē)植孔⑸鋵?duì)控制初次行全膝關(guān)節(jié)置換手術(shù)失血量的有效性及安全性。 方法 回顧性分析2015年6月~2016年10月在中國(guó)中醫(yī)科學(xué)院廣安門(mén)醫(yī)院南區(qū)骨二科行全膝關(guān)節(jié)置換患者90例,根據(jù)治療方案分為治療組45例和對(duì)照組45例,治療組采用雞尾酒療法膝關(guān)節(jié)囊周?chē)植孔⑸洌?0 mL關(guān)節(jié)腔內(nèi)灌注;對(duì)照組采用生理鹽水關(guān)節(jié)腔內(nèi)灌注。術(shù)中兩組均采用骨蠟局部封堵止血,術(shù)后夾閉引流管3 h,術(shù)后24 h拔除引流管,分別記錄術(shù)后引流量、隱性失血量、凝血酶原時(shí)間(PT)、活化部分凝血活酶時(shí)間(APTT),國(guó)際標(biāo)準(zhǔn)化比值(INR)、D-二聚體(D-dimer),觀察患者下肢血栓發(fā)生例數(shù)。 結(jié)果 治療組患者術(shù)后顯性失血量、隱性失血量少于對(duì)照組,輸血人數(shù)少于對(duì)照組,差異有高度統(tǒng)計(jì)學(xué)意義(P < 0.01);兩組化驗(yàn)PT、APTT、INR、D-dimer比較差異無(wú)統(tǒng)計(jì)學(xué)意義(P > 0.05);兩組血栓發(fā)生率差異無(wú)統(tǒng)計(jì)學(xué)意義(P > 0.05)。 結(jié)論 雞尾酒療法能有效減少初次全膝關(guān)節(jié)置換圍術(shù)期失血量,是一種行之有效、安全的治療方法。

        [關(guān)鍵詞] 雞尾酒療法;氨甲環(huán)酸;骨蠟;全膝關(guān)節(jié)置換術(shù);隱性失血;止血

        [中圖分類(lèi)號(hào)] R687.4 [文獻(xiàn)標(biāo)識(shí)碼] A [文章編號(hào)] 1673-7210(2018)04(c)-0065-04

        Effect of cocktail drug injection on blood loss and safety evaluation after primary total knee arthroplasty

        BI Chunqiang1 WEN Jianmin2 ZHANG Hui1 YANG Dawei1 SONG Xue1 LI Duoduo3

        1.Second Department of Orthopaedics, Guang′anmen Hospital South District of China Academy of Chinese Medicine Sciences, Beijing 102618, China; 2.Second Department of Orthopaedics, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing 100102, China; 3.Massage Department, Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing 100700, China

        [Abstract] Objective To investigate the effectiveness and safety of cocktail drug injection on blood loss and safety evaluation of local injection after primary total knee arthroplasty (TKA). Methods Ninety patients who received primary TKA from June 2015 to October 2016 in Guang′anmen Hospital South district of China Academy of Chinese Medicine Sciences was retrospectively analysed and divided into treatment group and control group, with 45 cases in each group. Treatment group was treated with cocktail drug injection around knee joint capsule and 50 mL intra-articular injection, the control group were treated with saline intra-articular infusion. The bone wax was used to stop the bleeding in the two groups, and the drainage tube was clamped for 3 hours and removed 24 hours after the operation. Postoperative drainage, occult blood loss, prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ration (INR), D-dimer value and deep venous thrombosis cases were recorded in both group. Results The dominant blood loss and hidden hemorrhage in the treatment group were less than the control group, the number of blood transfusion was less than the control group, the differences were highly statistically significant (P < 0.01). Both groups had no statistically significant in PT, APTT, INR, D-dimer value (P > 0.05). The incidence of thrombosis was no statistically significant between the two groups (P > 0.05). Conclusion The cocktail drug injection thearapy is an effective and safe method to control the amount of blood loss during the operation of primary TKA.

        [Key words] Cocktail therapy; Tranexamic acid; Bone wax; Total knee arthroplasty; Hidden hemorrhage; Hemostasis

        全膝關(guān)節(jié)置換術(shù)(total knee arthroplasty,TKA)是晚期膝骨關(guān)節(jié)炎的最終治療方案,據(jù)統(tǒng)計(jì)TKA在美國(guó)每年可達(dá)幾十萬(wàn)[1],我國(guó)行TKA的患者也日益增多,TKA技術(shù)日趨成熟,但該手術(shù)需截骨、開(kāi)髓、廣泛剝離軟組織,存在術(shù)后大量失血和高輸血率的弊端[2-5],據(jù)報(bào)道,未經(jīng)處理的單側(cè)TKA出血量可達(dá)到300~2200 mL,輸血率可達(dá)11%~67%[6-8],隱性失血被認(rèn)為是造成術(shù)后貧血、行走功能恢復(fù)障礙的主要原因[9]。一種新型配方的雞尾酒療法用于TKA術(shù)后患者止血,減少總失血量、隱形失血量、降低輸血風(fēng)險(xiǎn)單又不增加血栓發(fā)生率[10-13],本課題采用回顧性研究,探討雞尾酒療法對(duì)TKA術(shù)后失血量的影響,現(xiàn)報(bào)道如下:

        1 資料與方法

        1.1 一般資料

        回顧性分析2015年6月~2016年10月在中國(guó)中醫(yī)科學(xué)院廣安門(mén)醫(yī)院南區(qū)骨二科以膝骨關(guān)節(jié)炎入院行初次單側(cè)TKA患者90例,根據(jù)治療方案分為治療組和對(duì)照組,各45例。診斷符合2010年中華醫(yī)學(xué)會(huì)風(fēng)濕病學(xué)分會(huì)膝骨關(guān)節(jié)炎診斷標(biāo)準(zhǔn)[14]。納入標(biāo)準(zhǔn):第一診斷為膝骨關(guān)節(jié)炎;年齡60~80歲;身體一般狀況良好,無(wú)明顯心肺功能異常,無(wú)藥物過(guò)敏史;術(shù)前血紅蛋白、血細(xì)胞比容(HCT)、凝血功能檢查正常;病例資料完整。排除標(biāo)準(zhǔn):凝血障礙、貧血;患側(cè)下肢有血栓疾病、感染史;惡性腫瘤、腦血管病史;嚴(yán)重肝腎功不全;周?chē)窠?jīng)血管病變;有抗凝禁忌。兩組患者性別、年齡、身高、體重、體重指數(shù)等一般資料比較,差異無(wú)統(tǒng)計(jì)學(xué)意義(P > 0.05),具有可比性。見(jiàn)表1。本研究經(jīng)醫(yī)院醫(yī)學(xué)倫理委員會(huì)通過(guò),患者知情同意并簽署知情同意書(shū)。

        1.2 TKA操作及止血方法

        手術(shù)均由同一主刀醫(yī)生完成,均采用腰硬聯(lián)合麻醉,麻醉后使用氣囊止血帶壓力35~40 kPa,采用標(biāo)準(zhǔn)膝前正中切口,髕骨內(nèi)側(cè)入路,顯露關(guān)節(jié)腔,切除增生骨贅、滑膜、半月板等,松解軟組織,股骨遠(yuǎn)端及脛骨平臺(tái)截骨,平衡內(nèi)外側(cè)間隙,恢復(fù)下肢力線,采用后交叉韌帶替代型骨水泥固定人工膝關(guān)節(jié)假體(施樂(lè)輝公司生產(chǎn)),股骨髓腔開(kāi)孔均用自體截骨塊封堵,髕骨面修整,假體安裝后待骨水泥完全固化時(shí),在股骨及脛骨假體未覆蓋的截骨面以及定位骨孔使用骨蠟(美國(guó)強(qiáng)生公司生產(chǎn),生產(chǎn)批號(hào):KG5DPRM)涂抹封閉。

        以上操作完成后,治療組采用雞尾酒療法局部注射,術(shù)中將氨甲環(huán)酸(長(zhǎng)春天誠(chéng)藥業(yè)有限公司生產(chǎn),生產(chǎn)批號(hào):201504221)0.5 g,地塞米松磷酸鈉注射液(天津金耀藥業(yè)有限公司生產(chǎn),生產(chǎn)批號(hào):1608111)5 mg,鹽酸腎上腺素注射液0.15 mg(哈藥集團(tuán)三精制藥有限公司生產(chǎn),生產(chǎn)批號(hào):1508231)3滴,羅哌卡因注射液(瑞典AstraZeneca AB公司生產(chǎn),生產(chǎn)批號(hào):LBCD)10 mL,配成111 mL雞尾酒混合液,安裝假體后在后關(guān)節(jié)囊、周?chē)‰煲约吧畈拷钅そM織等部位行多點(diǎn)局部注射,用量約60 mL,注意避開(kāi)血管和神經(jīng),逐層縫合,放置引流管,無(wú)菌紗布、棉墊包扎傷口,將剩余約50 mL雞尾酒混合液通過(guò)引流管注入關(guān)節(jié)腔后夾閉引流管。

        對(duì)照組局部不注射,將50 mL生理鹽水通過(guò)引流管注入關(guān)節(jié)腔后夾閉引流管。

        1.3 術(shù)后處理

        術(shù)后常規(guī)抗生素預(yù)防性應(yīng)用,保持患肢中立位,3 h后打開(kāi)引流管,改為自然引流,術(shù)后24 h拔除引流管。拔除引流管后即指導(dǎo)患者主動(dòng)背伸、跖屈踝關(guān)節(jié),進(jìn)行肌肉等長(zhǎng)收縮鍛煉,行肢體功能康復(fù)訓(xùn)練。術(shù)后12 h開(kāi)始皮下注射低分子肝素(天津紅日藥業(yè)股份有限公司生產(chǎn),生產(chǎn)批號(hào):1505191)6000 U,1次/d,抗凝共2周。術(shù)后綜合患者傷口引流及皮下滲血及血常規(guī)等實(shí)驗(yàn)室檢查結(jié)果決定是否輸血。輸血指征為患者出現(xiàn)明顯的貧血癥狀或Hb低于70g /L。術(shù)后3~5 d在助行器輔助下地,術(shù)后14 d拆線。

        1.4 觀察指標(biāo)

        術(shù)后24 h拔除引流管時(shí),記錄化驗(yàn)?zāi)冈瓡r(shí)間(PT)、活化部分凝血活酶時(shí)間(APTT),國(guó)際標(biāo)準(zhǔn)化比值(INR)、D-二聚體(D-dimer),記錄引流量。術(shù)后7 d復(fù)查雙下肢血管彩超檢查,觀察深靜脈血栓發(fā)生率,記錄輸血人數(shù)。

        總失血量為術(shù)中失血量與術(shù)后失血量之和。術(shù)后失血量為顯性失血量與隱性失血量之和,顯性失血量=術(shù)后引流量-術(shù)中關(guān)節(jié)腔注射的50 mL液體;隱性失血量根據(jù)Gross[15]的循環(huán)血量計(jì)算方程式算出。根據(jù)Nadler[16]提出的方程式計(jì)算術(shù)前總血容量。即:總血容量 = K1×身高(m)+K2×體質(zhì)量(kg)+K3,其中男性:K1 = 0.3669,K2 = 0.03219,K3 = 0.6041;女性:K1 = 0.3561,K2 = 0.03308,K3 = 0.1833,總失血量 = 總血容量×(術(shù)前HCT-術(shù)后HCT),隱性失血量 = 總失血量-顯性失血量-術(shù)中出血量+輸血量。

        1.5 統(tǒng)計(jì)學(xué)方法

        采用SPSS 17.0對(duì)所得數(shù)據(jù)進(jìn)行統(tǒng)計(jì)學(xué)分析,計(jì)量資料采用均數(shù)±標(biāo)準(zhǔn)差(x±s)表示,組間比較采用t檢驗(yàn),計(jì)數(shù)資料采用百分率表示,組間比較采用χ2檢驗(yàn)。以P < 0.05為差異有統(tǒng)計(jì)學(xué)意義。

        2 結(jié)果

        2.1 術(shù)后失血量及輸血人數(shù)比較

        治療組顯性失血量和隱性失血量明顯低于對(duì)照組,差異有統(tǒng)計(jì)學(xué)意義(P < 0.01)。治療組輸血人數(shù)少于對(duì)照組,差異有高度統(tǒng)計(jì)學(xué)意義(P < 0.01)。見(jiàn)表2。

        2.2 兩組凝血功能比較

        術(shù)后24 h兩組凝血功能檢測(cè)PT、APTT、INR、D-dimer比較,差異無(wú)統(tǒng)計(jì)學(xué)意義(P > 0.05)。見(jiàn)表3。

        2.3 兩組下肢血栓發(fā)生率比較

        兩組各有2例發(fā)生腓腸肌肌間靜脈血栓,差異無(wú)統(tǒng)計(jì)學(xué)意義(P > 0.05)。經(jīng)對(duì)癥治療,恢復(fù)較好。

        3 討論

        TKA是目前治療重度膝骨關(guān)節(jié)炎的最終治療手段,可以明顯改善關(guān)節(jié)疼痛、畸形,糾正下肢力線,重建關(guān)節(jié)功能[17-18]。TKA患者隱性出血量可達(dá)其總出血量的50%左右[19-20],已成為困擾外科醫(yī)生的主要問(wèn)題。由于患者為中老年人,控制出血量對(duì)降低患者醫(yī)療費(fèi)用、減少輸血風(fēng)險(xiǎn)、促進(jìn)患者康復(fù)等方面十分重要。

        骨蠟和氨甲環(huán)酸都是TKA中常用的止血措施,骨蠟涂抹于截骨面和定位骨孔后通過(guò)機(jī)械性屏障控制骨面出血[21]。關(guān)節(jié)周?chē)u尾酒藥物注射療法由Kerr等[22]首次報(bào)道,現(xiàn)已成為髖、膝關(guān)節(jié)置換術(shù)后疼痛管理和止血的最為流行的解決方案,其具有較好的鎮(zhèn)痛效果,可以較好地控制術(shù)后疼痛,減少不良反應(yīng),幫助患者康復(fù)。最常規(guī)的組方為一種局麻藥,一種NSAID以及腎上腺素。羅哌卡因具有較長(zhǎng)的半衰期和較低的毒性,是雞尾酒組方中最常用的藥物[23]。腎上腺素由于其血管收縮作用而被應(yīng)用于雞尾酒療法中,可能是通過(guò)其血管收縮作用延緩止痛藥的吸收代謝減少出血。地塞米松加強(qiáng)其抗炎效果[24]。氨甲環(huán)酸阻止纖溶酶降解纖維蛋白,從而產(chǎn)生手術(shù)切口止血作用[25-26]。行關(guān)節(jié)置換的患者多為老年人,是血栓發(fā)生的高危人群,有研究證實(shí)其局部注射有良好的止血效果且安全有效,可明顯減少術(shù)后出血量和關(guān)節(jié)腫脹,不增加血栓風(fēng)險(xiǎn)[27-28]。

        本研究中,將雞尾酒復(fù)方聯(lián)合應(yīng)用,經(jīng)90例患者回顧性分析,治療組在控制出血量方面作用突出,兩組無(wú)不良事件發(fā)生,研究提示該雞尾酒組方具有滿意的臨床療效,是一種行之有效、安全的治療方法。本研究也存在不足之處,回顧性研究樣本量有限,未進(jìn)行大樣本、多中心對(duì)照研究,隨訪時(shí)間相對(duì)較短,使研究結(jié)果存在一定的偏倚,該組方雞尾酒療法在止血和鎮(zhèn)痛方面療效和安全性有待于進(jìn)一步科學(xué)評(píng)價(jià)。

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        (收稿日期:2017-10-22 本文編輯:劉學(xué)梅)

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