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氨甲环酸关节腔内应用显著减少初次全膝关节置换术中的失血量及输血需求

[Intra-Articular Application of Tranexamic Acid Significantly Reduces Blood Loss and Transfusion Requirement in Primary Total Knee Arthroplasty].

作者信息

Lošťák J, Gallo J, Špička J, Langová K

出版信息

Acta Chir Orthop Traumatol Cech. 2016;83(4):254-262.

Abstract

PURPOSE OF THE STUDY The aim of this prospective study was to investigate the effect of topical application of tranexamic acid (TXA, Exacyl) on the amount of post-operative blood loss, and blood transfusion requirement in patients undergoing primary total knee arthroplasty (TKA). Attention was paid to early complications potentially associated with TXA administration, such as haematoma, wound exudate, or knee swelling. In addition, the economic benefit of TXA treatment was also taken into account. MATERIAL AND METHODS The study included 238 patients (85 men and 153 women) who underwent primary total knee arthroplasty (TKA) at our department between January 2013 and November 2015. A group of 119 patients (41 men and 78 women) received intraarticular TXA injections according to the treatment protocol (TXA group). A control group matched in basic characteristics to the TXA group also consisted of 119 patients. The average age in the TXA group was 69.8 years, and the most frequent indication for TKA surgery was primary knee osteoarthritis (81.5%). In each patient, post-operative volume of blood lost from drains and total blood loss including hidden blood loss were recorded, as well as post-operative haemoglobin and haematocrit levels. On discharge of each patient from hospital, the size and site of a haematoma; wound exudate, if present after post-operative day 4; joint swelling; range of motion and early revision surgery, if performed, were evaluated. Requirements of analgesic drugs after surgery were also recorded. RESULTS In the TXA group, blood losses from drains were significantly lower than in the control group (456.7 ± 270.8 vs 640.5 ±448.2; p = 0.004). The median value for blood losses from drains was lower by 22% and the average value for total blood loss, including hidden losses, was also lower than in the control group (762.4 ± 345.2 ml vs 995.5 ± 457.3 ml). The difference in the total amount of blood loss between the two groups was significant (p = 0.0001), including hidden blood loss (p = 0.030). The TXA patients had significantly fewer requirements for allogeneic blood transfusion (p < 0.0004), higher post-operative haemoglobin levels (p = 0.014), lower incidence of haematomas (p = 0.0003), and a significantly higher flexion degree on discharge from hospital (p < 0.0001). No higher volume of wound drainage was found (p = 1.000). Only one patient of the TXA group underwent revision surgery due to wound healing disturbance. The total costs of blood transfusion requirements were significantly lower in the TXA group than in the control group (p = 0.0004). DISCUSSION Topical administration allows the antifibrinolytic effect of TXA to act directly at a bleeding site. Its advantages involve easy application, maximum TXA concentration at the site of application, no danger associated with administration of a higher TXA dose and minimal TXA resorption into the circulation. On the other hand, there are no exact instructions for an effective and safe topical application of TXA and some authors are concerned that a coagulum arising after TXA application might affect soft tissue behaviour (healing, swelling, rehabilitation) or result in infection. CONCLUSIONS The study showed the efficacy and safety of topical TXA administration resulting in lower peri-operative bleeding, fewer blood transfusion requirements and higher haemoglobin levels after TKA. The patients treated with TXA had less knee swelling, lower incidence of haematomas and used fewer analgesic drugs in the early post-operative period. The economic benefit is also worth considering. In agreement with the recent literature, it is suggested to add topical TXA application to the recommended procedures for TKA surgery. Key words: tranexamic acid, Exacyl, topical application, intra-articular application, blood loss, hidden blood loss, total knee arthroplasty, complications.

摘要

研究目的 本前瞻性研究的目的是调查局部应用氨甲环酸(TXA,速碧林)对初次全膝关节置换术(TKA)患者术后失血量及输血需求的影响。同时关注与TXA给药潜在相关的早期并发症,如血肿、伤口渗出或膝关节肿胀。此外,还考虑了TXA治疗的经济效益。

材料与方法 本研究纳入了2013年1月至2015年11月期间在我科接受初次全膝关节置换术(TKA)的238例患者(85例男性和153例女性)。根据治疗方案,119例患者(41例男性和78例女性)接受关节内TXA注射(TXA组)。与TXA组基本特征匹配的对照组也由119例患者组成。TXA组的平均年龄为69.8岁,TKA手术最常见的指征是原发性膝关节骨关节炎(81.5%)。记录每位患者术后引流管失血量、包括隐性失血在内的总失血量,以及术后血红蛋白和血细胞比容水平。在每位患者出院时,评估血肿的大小和部位;术后第4天之后若有伤口渗出情况;关节肿胀;活动范围以及是否进行了早期翻修手术(若进行了手术)。还记录了术后镇痛药的需求情况。

结果 TXA组引流管失血量显著低于对照组(456.7±270.8 vs 640.5±448.2;p = 0.004)。引流管失血量的中位数低22%,包括隐性失血在内的总失血量平均值也低于对照组(762.4±345.2 ml vs 995.5±457.3 ml)。两组间总失血量差异显著(p = 0.0001),包括隐性失血(p = 0.030)。TXA组患者异体输血需求显著减少(p < 0.0004),术后血红蛋白水平更高(p = 0.014),血肿发生率更低(p = 0.0003),出院时屈曲度显著更高(p < 0.0001)。未发现伤口引流量增加(p = 1.000)。TXA组仅1例患者因伤口愈合障碍接受了翻修手术。TXA组输血需求的总成本显著低于对照组(p = 0.0004)。

讨论 局部给药可使TXA的抗纤维蛋白溶解作用直接作用于出血部位。其优点包括应用简便、应用部位TXA浓度最高、不存在高剂量TXA给药相关风险且TXA吸收入循环的量最少。另一方面,目前尚无关于TXA有效且安全的局部应用的确切指导,一些作者担心TXA应用后形成的凝块可能影响软组织行为(愈合、肿胀、康复)或导致感染。

结论 本研究表明局部应用TXA有效且安全,可减少TKA围手术期出血、降低输血需求并提高术后血红蛋白水平。接受TXA治疗的患者膝关节肿胀减轻、血肿发生率降低且术后早期使用的镇痛药减少。其经济效益也值得考虑。与近期文献一致,建议将局部应用TXA添加到TKA手术的推荐操作中。

关键词

氨甲环酸;速碧林;局部应用;关节内应用;失血量;隐性失血;全膝关节置换术;并发症

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