Kim Man Soo, Koh In Jun, Choi Keun Young, Yang Sung Cheol, In Yong
Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222, Banpo-daero, Seocho-gu, Seoul 06591, Korea.
Department of Orthopaedic Surgery, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 1021, Tongil Ro, Eunpyeong-gu, Seoul 03312, Korea.
J Clin Med. 2021 Apr 2;10(7):1457. doi: 10.3390/jcm10071457.
(1) Background: The purpose of this study was to evaluate the efficacy and safety of intravenous (IV) ferric carboxymaltose (FCM) to treat acute postoperative anemia following same-day bilateral total knee arthroplasty (TKA). (2) Methods: A total of 118 patients who underwent same-day bilateral TKA were randomly assigned to two groups: an FCM group (FCM infusion, 58 patients) and a Control group (placebo with normal saline, 60 patients). The primary endpoint was the number of responders with a Hb increase of two or more points by the second postoperative week. The secondary endpoints were Hb level, iron metabolism variables and blood transfusion rate at 2, 6 and 12 weeks after surgery. (3) Results: The FCM group had more Hb responders than the Control group (62.1% vs. 31.6%, < 0.001). The Hb level was significantly higher in the FCM group during 12 weeks after surgery (all < 0.05). Ferritin, iron and transferrin saturation levels were significantly higher in the FCM group from 2 to 12 weeks postoperatively (all < 0.05). There was no difference in transfusion rate after surgery ( > 0.05). (4) Conclusion: In patients with postoperative anemia after same-day bilateral TKA, IV FCM infusion significantly improved Hb response two weeks after surgery without severe adverse events compared to placebo. In contrast, transfusion rate and various parameters of quality of life assessment up to 12 weeks did not vary between these groups. Level of evidence: Level I.
（1）背景：本研究旨在评估静脉注射羧基麦芽糖铁（FCM）治疗同日双侧全膝关节置换术（TKA）后急性术后贫血的疗效和安全性。（2）方法：总共118例行同日双侧TKA的患者被随机分为两组：FCM组（静脉输注FCM，58例患者）和对照组（生理盐水安慰剂，60例患者）。主要终点是术后第二周血红蛋白增加两个或更多点的有反应者数量。次要终点是术后2、6和12周时的血红蛋白水平、铁代谢变量和输血率。（3）结果：FCM组血红蛋白有反应者多于对照组（62.1%对31.6%，<0.001）。术后12周内FCM组的血红蛋白水平显著更高（均<0.05）。术后2至12周，FCM组的铁蛋白、铁和转铁蛋白饱和度水平显著更高（均<0.05）。术后输血率无差异（>0.05）。（4）结论：对于同日双侧TKA术后贫血患者，与安慰剂相比，静脉输注FCM在术后两周显著改善了血红蛋白反应，且无严重不良事件。相比之下，两组在12周内的输血率和生活质量评估的各项参数并无差异。证据等级：I级。
