CORR Insights®:联合静脉注射和关节内注射氨甲环酸在双侧TKA中与单独关节内使用相比没有额外的益处:一项随机对照试验。

M. Grecula
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This drug has been a game-changer for arthroplasty patients who previously had been treated with a host of interventions to try to mitigate blood loss and reduce transfusion after TKA, including preoperative autologous blood donation, pre-operative stimulation of erythropoiesis, controlled hypotension, hemodilution, intra-operative or post-operative blood salvage, tourniquet use and timing of deflation, thermal energy, fibrin spray, peri-articular injections, continuous passive motion versus splinting, intra-operative and post-operative knee positioning, and cryotherapy [9, 10]. Introduced in 1962 as a treatment to reduce the severity of post-partum hemorrhage [20], TXA was first approved by the US Food and Drug Administration in 1986 to reduce bleeding in patients with hemophilia undergoing tooth extraction [4]. Despite increasing evidence supporting TXA use in multiple medical disciplines, and its inclusion on the World Health Organization’s list of essential medicines [21], the FDA has only expanded its use to include treating heavy cyclic menstrual bleeding [11]. Despite the fact that any use of TXA in patients undergoing TKA is considered offlabel by the FDA, its use in TKA now is widespread and well supported by randomized trials [6, 12, 17] and numerous meta-analyses [3, 8, 22, 23]. Being an anti-fibrinolytic, TXA has the theoretical risk of harmful vascular thrombosis, and thus empirically, caution has been used in orthopedic studies by excluding patients with previous history (or increased risk) of thromboembolic events, including patients who have had or are at risk for deep vein thrombosis/pulmonary embolism, stroke, myocardial infarction, history of cardiac stents or bypass surgery, or who have thrombophilia [12, 17]. 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Despite increasing evidence supporting TXA use in multiple medical disciplines, and its inclusion on the World Health Organization’s list of essential medicines [21], the FDA has only expanded its use to include treating heavy cyclic menstrual bleeding [11]. Despite the fact that any use of TXA in patients undergoing TKA is considered offlabel by the FDA, its use in TKA now is widespread and well supported by randomized trials [6, 12, 17] and numerous meta-analyses [3, 8, 22, 23]. Being an anti-fibrinolytic, TXA has the theoretical risk of harmful vascular thrombosis, and thus empirically, caution has been used in orthopedic studies by excluding patients with previous history (or increased risk) of thromboembolic events, including patients who have had or are at risk for deep vein thrombosis/pulmonary embolism, stroke, myocardial infarction, history of cardiac stents or bypass surgery, or who have thrombophilia [12, 17]. 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引用次数: 1

摘要

对TKA患者采取血液保护措施很重要,因为术后输血会增加严重并发症的风险,包括假体关节感染和死亡。术后贫血也与住院时间延长和康复延迟有关;这些风险在有其他合并症的患者中尤为严重。目前最好的证据支持使用氨甲环酸(TXA)[5]。这种药物改变了关节置换术患者的游戏规则,这些患者之前接受了一系列干预措施,试图减轻TKA后的失血和输血,包括术前自体献血,术前刺激红细胞生成,控制低血压,血液稀释,术中或术后血液回收,止血带的使用和放空时间,热能,纤维蛋白喷雾,关节周围注射,持续被动运动与夹板、术中及术后膝关节定位和冷冻治疗的对比[9,10]。TXA于1962年作为一种减轻产后出血严重程度的治疗方法被引入,1986年首次被美国食品和药物管理局批准用于减少血友病患者拔牙时出血。尽管越来越多的证据支持TXA在多个医学领域的使用,并且它被列入世界卫生组织的基本药物清单,FDA只扩大了它的使用范围,包括治疗重度月经周期出血。尽管事实上,在接受TKA的患者中使用TXA被FDA认为是标签外的,但它在TKA中的使用现在是广泛的,并且得到了随机试验[6,12,17]和大量荟萃分析[3,8,22,23]的充分支持。作为一种抗纤溶药物,TXA具有有害血管血栓形成的理论风险,因此在骨科研究中,谨慎排除有血栓栓塞事件史(或风险增加)的患者,包括有或有深静脉血栓/肺栓塞、中风、心肌梗死、心脏支架或搭桥手术史或有血栓倾向的患者[12,17]。然而,这些理论上的风险尚未在多个大型研究中得到证实。目前由Meshram及其同事[14]进行的随机双盲试验发现,在同时使用IA组和联合IA和IV组之间,主要和次要结局变量没有“临床显著差异”。这篇CORR Insights是对“联合静脉注射和关节内注射氨甲环酸与单独关节内使用相比,在双侧TKA中没有额外的益处”一文中的评论:Meshram及其同事的《随机对照试验》可在:DOI: 10。1097 / CORR.0000000000000942。提交人证明,他本人及其直系亲属均无任何可能与所提交文章产生利益冲突的商业协会(如咨询公司、股票所有权、股权、专利/许可安排等)。所表达的观点是作者的观点,不反映CORR或骨关节外科医生协会的观点或政策。M. J. greula MD (MD),美国德克萨斯大学医学院骨科康复科,301 University Blvd。, 0165号公路,加尔维斯顿,得克萨斯州77555美国,电子邮件:mgrecula@utmb.edu
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CORR Insights®: Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.
Taking blood conservation measures for patients undergoing TKA is important because blood transfusions after surgery can increase the risk of serious complications, including prosthetic joint infection and death. Post-operative anemia also is associated with prolonged hospital stay and delayed rehabilitation; these risks are especially severe in patients with other comorbidities [18]. The best current evidence now favors use of tranexamic acid (TXA) [5]. This drug has been a game-changer for arthroplasty patients who previously had been treated with a host of interventions to try to mitigate blood loss and reduce transfusion after TKA, including preoperative autologous blood donation, pre-operative stimulation of erythropoiesis, controlled hypotension, hemodilution, intra-operative or post-operative blood salvage, tourniquet use and timing of deflation, thermal energy, fibrin spray, peri-articular injections, continuous passive motion versus splinting, intra-operative and post-operative knee positioning, and cryotherapy [9, 10]. Introduced in 1962 as a treatment to reduce the severity of post-partum hemorrhage [20], TXA was first approved by the US Food and Drug Administration in 1986 to reduce bleeding in patients with hemophilia undergoing tooth extraction [4]. Despite increasing evidence supporting TXA use in multiple medical disciplines, and its inclusion on the World Health Organization’s list of essential medicines [21], the FDA has only expanded its use to include treating heavy cyclic menstrual bleeding [11]. Despite the fact that any use of TXA in patients undergoing TKA is considered offlabel by the FDA, its use in TKA now is widespread and well supported by randomized trials [6, 12, 17] and numerous meta-analyses [3, 8, 22, 23]. Being an anti-fibrinolytic, TXA has the theoretical risk of harmful vascular thrombosis, and thus empirically, caution has been used in orthopedic studies by excluding patients with previous history (or increased risk) of thromboembolic events, including patients who have had or are at risk for deep vein thrombosis/pulmonary embolism, stroke, myocardial infarction, history of cardiac stents or bypass surgery, or who have thrombophilia [12, 17]. However, these theoretical risks have not been confirmed in multiple large studies [13]. The current randomized, doubleblind trial by Meshram and colleagues [14] found no “clinically significant difference” in both the primary and secondary outcome variables between the IA only and combined IA and IV groups in both the simultaneous and This CORR Insights is a commentary on the article “Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial” by Meshram and colleagues available at: DOI: 10. 1097/CORR.0000000000000942. The author certifies that neither he, nor any members of his immediate family, have any commercial associations (such as consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article. The opinions expressed are those of the writer, and do not reflect the opinion or policy of CORR or The Association of Bone and Joint Surgeons. M. J. Grecula MD (✉), University of Texas Medical Branch, Department of Orthopaedic Surgery and Rehabilitation, 301 University Blvd., Route 0165, Galveston, TX 77555 USA, Email: mgrecula@utmb.edu
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