Zufferey Paul, Merquiol Fanette, Laporte Silvy, Decousus Hervé, Mismetti Patrick, Auboyer Christian, Samama Charles Marc, Molliex Serge
Department of Anesthesiology and Intensive Care and EA3065, Thrombosis Research Group, University Hospital of Saint-Etienne, Saint-Etienne, France.
Anesthesiology. 2006 Nov;105(5):1034-46. doi: 10.1097/00000542-200611000-00026.
Studies have shown that antifibrinolytic (aprotinin, tranexamic acid, epsilon-aminocaproic acid) reduce blood loss in orthopedic surgery. However, most lacked sufficient power to evaluate the efficacy and safety on clinical outcomes. This meta-analysis aims to evaluate whether intravenous antifibrinolytics, when compared with placebo, reduce perioperative allogeneic erythrocyte transfusion requirement in adults undergoing orthopedic surgery and whether it might increase the risk of venous thromboembolism. From MEDLINE, EMBASE, and the Cochrane Controlled Trials Register, the authors identified 43 randomized controlled trials in total hip and knee arthroplasty, spine fusion, musculoskeletal sepsis, or tumor surgery performed to July 2005 (for aprotinin, 23 trials with 1,268 participants; tranexamic acid, 20 with 1,084; epsilon-aminocaproic acid, 4 with 171). Aprotinin and tranexamic acid reduced significantly the proportion of patients requiring allogeneic erythrocyte transfusion according to a transfusion protocol. The odds ratio was 0.43 (95% confidence interval, 0.28-0.64) for aprotinin and 0.17 (0.11-0.24) for tranexamic acid. Results suggest a dose-effect relation with tranexamic acid. Epsilon-aminocaproic acid was not efficacious. Unfortunately, data were too limited for any conclusions regarding safety. Although the results suggest that aprotinin and tranexamic acid significantly reduce allogeneic erythrocyte transfusion, further evaluation of safety is required before recommending the use of antifibrinolytics in orthopedic surgery.
研究表明，抗纤溶药物（抑肽酶、氨甲环酸、ε-氨基己酸）可减少骨科手术中的失血。然而，大多数研究缺乏足够的效力来评估其对临床结局的有效性和安全性。本荟萃分析旨在评估与安慰剂相比，静脉使用抗纤溶药物是否能减少接受骨科手术的成人围手术期异体红细胞输注需求，以及是否可能增加静脉血栓栓塞的风险。作者从MEDLINE、EMBASE和Cochrane对照试验注册库中，确定了截至2005年7月在全髋关节和膝关节置换术、脊柱融合术、肌肉骨骼感染或肿瘤手术中进行的43项随机对照试验（抑肽酶，23项试验，1268名参与者；氨甲环酸，20项试验，1084名；ε-氨基己酸，4项试验，171名）。根据输血方案，抑肽酶和氨甲环酸显著降低了需要异体红细胞输注的患者比例。抑肽酶的比值比为0.43（95%置信区间，0.28 - 0.64），氨甲环酸为0.17（0.11 - 0.24）。结果表明氨甲环酸存在剂量效应关系。ε-氨基己酸无效。遗憾的是，关于安全性的数据有限，无法得出任何结论。尽管结果表明抑肽酶和氨甲环酸可显著减少异体红细胞输注，但在推荐在骨科手术中使用抗纤溶药物之前，还需要进一步评估安全性。
