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鸡尾酒疗法对初次全膝关节置换术后失血量的影响及安全性评价

2018-06-20毕春强温建民张辉杨大伟宋雪李多多

中国医药导报 2018年12期
关键词:止血全膝关节置换术氨甲环酸

毕春强 温建民 张辉 杨大伟 宋雪 李多多

[摘要] 目的 探讨鸡尾酒疗法关节囊周围局部注射对控制初次行全膝关节置换手术失血量的有效性及安全性。 方法 回顾性分析2015年6月~2016年10月在中国中医科学院广安门医院南区骨二科行全膝关节置换患者90例,根据治疗方案分为治疗组45例和对照组45例,治疗组采用鸡尾酒疗法膝关节囊周围局部注射,50 mL关节腔内灌注;对照组采用生理盐水关节腔内灌注。术中两组均采用骨蜡局部封堵止血,术后夹闭引流管3 h,术后24 h拔除引流管,分别记录术后引流量、隐性失血量、凝血酶原时间(PT)、活化部分凝血活酶时间(APTT),国际标准化比值(INR)、D-二聚体(D-dimer),观察患者下肢血栓发生例数。 结果 治疗组患者术后显性失血量、隐性失血量少于对照组,输血人数少于对照组,差异有高度统计学意义(P < 0.01);两组化验PT、APTT、INR、D-dimer比较差异无统计学意义(P > 0.05);两组血栓发生率差异无统计学意义(P > 0.05)。 结论 鸡尾酒疗法能有效减少初次全膝关节置换围术期失血量,是一种行之有效、安全的治疗方法。

[关键词] 鸡尾酒疗法;氨甲环酸;骨蜡;全膝关节置换术;隱性失血;止血

[中图分类号] R687.4 [文献标识码] A [文章编号] 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

全膝关节置换术(total knee arthroplasty,TKA)是晚期膝骨关节炎的最终治疗方案,据统计TKA在美国每年可达几十万[1],我国行TKA的患者也日益增多,TKA技术日趋成熟,但该手术需截骨、开髓、广泛剥离软组织,存在术后大量失血和高输血率的弊端[2-5],据报道,未经处理的单侧TKA出血量可达到300~2200 mL,输血率可达11%~67%[6-8],隐性失血被认为是造成术后贫血、行走功能恢复障碍的主要原因[9]。一种新型配方的鸡尾酒疗法用于TKA术后患者止血,减少总失血量、隐形失血量、降低输血风险单又不增加血栓发生率[10-13],本课题采用回顾性研究,探讨鸡尾酒疗法对TKA术后失血量的影响,现报道如下:

1 资料与方法

1.1 一般资料

回顾性分析2015年6月~2016年10月在中国中医科学院广安门医院南区骨二科以膝骨关节炎入院行初次单侧TKA患者90例,根据治疗方案分为治疗组和对照组,各45例。诊断符合2010年中华医学会风湿病学分会膝骨关节炎诊断标准[14]。纳入标准:第一诊断为膝骨关节炎;年龄60~80岁;身体一般状况良好,无明显心肺功能异常,无药物过敏史;术前血红蛋白、血细胞比容(HCT)、凝血功能检查正常;病例资料完整。排除标准:凝血障碍、贫血;患侧下肢有血栓疾病、感染史;恶性肿瘤、脑血管病史;严重肝肾功不全;周围神经血管病变;有抗凝禁忌。两组患者性别、年龄、身高、体重、体重指数等一般资料比较,差异无统计学意义(P > 0.05),具有可比性。见表1。本研究经医院医学伦理委员会通过,患者知情同意并签署知情同意书。

1.2 TKA操作及止血方法

手术均由同一主刀医生完成,均采用腰硬联合麻醉,麻醉后使用气囊止血带压力35~40 kPa,采用标准膝前正中切口,髌骨内侧入路,显露关节腔,切除增生骨赘、滑膜、半月板等,松解软组织,股骨远端及胫骨平台截骨,平衡内外侧间隙,恢复下肢力线,采用后交叉韧带替代型骨水泥固定人工膝关节假体(施乐辉公司生产),股骨髓腔开孔均用自体截骨块封堵,髌骨面修整,假体安装后待骨水泥完全固化时,在股骨及胫骨假体未覆盖的截骨面以及定位骨孔使用骨蜡(美国强生公司生产,生产批号:KG5DPRM)涂抹封闭。

以上操作完成后,治疗组采用鸡尾酒疗法局部注射,术中将氨甲环酸(长春天诚药业有限公司生产,生产批号:201504221)0.5 g,地塞米松磷酸钠注射液(天津金耀药业有限公司生产,生产批号:1608111)5 mg,盐酸肾上腺素注射液0.15 mg(哈药集团三精制药有限公司生产,生产批号:1508231)3滴,罗哌卡因注射液(瑞典AstraZeneca AB公司生产,生产批号:LBCD)10 mL,配成111 mL鸡尾酒混合液,安装假体后在后关节囊、周围肌腱以及深部筋膜组织等部位行多点局部注射,用量约60 mL,注意避开血管和神經,逐层缝合,放置引流管,无菌纱布、棉垫包扎伤口,将剩余约50 mL鸡尾酒混合液通过引流管注入关节腔后夹闭引流管。

对照组局部不注射,将50 mL生理盐水通过引流管注入关节腔后夹闭引流管。

1.3 术后处理

术后常规抗生素预防性应用,保持患肢中立位,3 h后打开引流管,改为自然引流,术后24 h拔除引流管。拔除引流管后即指导患者主动背伸、跖屈踝关节,进行肌肉等长收缩锻炼,行肢体功能康复训练。术后12 h开始皮下注射低分子肝素(天津红日药业股份有限公司生产,生产批号:1505191)6000 U,1次/d,抗凝共2周。术后综合患者伤口引流及皮下渗血及血常规等实验室检查结果决定是否输血。输血指征为患者出现明显的贫血症状或Hb低于70g /L。术后3~5 d在助行器辅助下地,术后14 d拆线。

1.4 观察指标

术后24 h拔除引流管时,记录化验凝血酶原时间(PT)、活化部分凝血活酶时间(APTT),国际标准化比值(INR)、D-二聚体(D-dimer),记录引流量。术后7 d复查双下肢血管彩超检查,观察深静脉血栓发生率,记录输血人数。

总失血量为术中失血量与术后失血量之和。术后失血量为显性失血量与隐性失血量之和,显性失血量=术后引流量-术中关节腔注射的50 mL液体;隐性失血量根据Gross[15]的循环血量计算方程式算出。根据Nadler[16]提出的方程式计算术前总血容量。即:总血容量 = K1×身高(m)+K2×体质量(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,总失血量 = 总血容量×(术前HCT-术后HCT),隐性失血量 = 总失血量-显性失血量-术中出血量+输血量。

1.5 统计学方法

采用SPSS 17.0对所得数据进行统计学分析,计量资料采用均数±标准差(x±s)表示,组间比较采用t检验,计数资料采用百分率表示,组间比较采用χ2检验。以P < 0.05为差异有统计学意义。

2 结果

2.1 术后失血量及输血人数比较

治疗组显性失血量和隐性失血量明显低于对照组,差异有统计学意义(P < 0.01)。治疗组输血人数少于对照组,差异有高度统计学意义(P < 0.01)。见表2。

2.2 两组凝血功能比较

术后24 h两组凝血功能检测PT、APTT、INR、D-dimer比较,差异无统计学意义(P > 0.05)。见表3。

2.3 兩组下肢血栓发生率比较

两组各有2例发生腓肠肌肌间静脉血栓,差异无统计学意义(P > 0.05)。经对症治疗,恢复较好。

3 讨论

TKA是目前治疗重度膝骨关节炎的最终治疗手段,可以明显改善关节疼痛、畸形,纠正下肢力线,重建关节功能[17-18]。TKA患者隐性出血量可达其总出血量的50%左右[19-20],已成为困扰外科医生的主要问题。由于患者为中老年人,控制出血量对降低患者医疗费用、减少输血风险、促进患者康复等方面十分重要。

骨蜡和氨甲环酸都是TKA中常用的止血措施,骨蜡涂抹于截骨面和定位骨孔后通过机械性屏障控制骨面出血[21]。关节周围鸡尾酒药物注射疗法由Kerr等[22]首次报道,现已成为髋、膝关节置换术后疼痛管理和止血的最为流行的解决方案,其具有较好的镇痛效果,可以较好地控制术后疼痛,减少不良反应,帮助患者康复。最常规的组方为一种局麻药,一种NSAID以及肾上腺素。罗哌卡因具有较长的半衰期和较低的毒性,是鸡尾酒组方中最常用的药物[23]。肾上腺素由于其血管收缩作用而被应用于鸡尾酒疗法中,可能是通过其血管收缩作用延缓止痛药的吸收代谢减少出血。地塞米松加强其抗炎效果[24]。氨甲环酸阻止纤溶酶降解纤维蛋白,从而产生手术切口止血作用[25-26]。行关节置换的患者多为老年人,是血栓发生的高危人群,有研究证实其局部注射有良好的止血效果且安全有效,可明显减少术后出血量和关节肿胀,不增加血栓风险[27-28]。

本研究中,将鸡尾酒复方联合应用,经90例患者回顾性分析,治疗组在控制出血量方面作用突出,两组无不良事件发生,研究提示该鸡尾酒组方具有满意的临床疗效,是一种行之有效、安全的治疗方法。本研究也存在不足之处,回顾性研究样本量有限,未进行大样本、多中心对照研究,随访时间相对较短,使研究结果存在一定的偏倚,该组方鸡尾酒疗法在止血和镇痛方面疗效和安全性有待于进一步科学评价。

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(收稿日期:2017-10-22 本文編辑:刘学梅)

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