Department of Orthopaedics, Szent-Györgyi Albert Clinical Center, University of Szeged, Semmelweis Street 6, 6725, Szeged, Hungary,
Arch Orthop Trauma Surg. 2014 Apr;134(4):449-57. doi: 10.1007/s00402-014-1933-8. Epub 2014 Feb 2.
Orally administered chemical thromboprophylactic agents for total hip replacement (THR) have become popular in recent years. Certain clinical trials suggest that the efficacy and the risk of major bleeding after administration of direct thrombin inhibitor dabigatran etexilate are equivalent to the clinical trial comparator, subcutaneous low-molecular-weight heparin enoxaparin. Our aim was to compare and evaluate the incidence of minor haemorrhagic and soft-tissue adverse effects of enoxaparin and dabigatran.
122 patients who were treated by elective cemented primary THR were enrolled in our quasi-randomised study. Two groups were formed according to which perioperative thromboprophylactic agent was used: 61 patients in enoxaparin group versus 61 patients in dabigatran group. Thigh volume changes, calculated perioperative blood loss, area of haematoma, wound bleeding, duration of wound discharge and intensity of serous wound discharge on postoperative day 3 and day 7 were recorded.
The duration and intensity of serous wound discharge differed significantly between the two groups. Duration of wound discharge after drain removal was 2.2 (±2.7) days in the dabigatran group and 1.2 (±1.9) days in the enoxaparin group (p < 0.05). Significant increase in serous discharge was found in the dabigatran group (p < 0.05) on third and seventh postoperative days compared to the enoxaparin group.
Both thromboprophylactic agents were found to have appropriate antithrombotic effects after THR. However, dabigatran was associated with an increased incidence of prolonged serous wound discharge, which might cause longer hospitalization and might instigate the use of prolonged antibiotic prophylaxis.
近年来，口服化学性抗血栓形成药物在全髋关节置换术（THR）中越来越受欢迎。某些临床试验表明，直接凝血酶抑制剂达比加群酯的疗效和大出血风险与皮下低分子肝素依诺肝素的临床试验对照剂相当。我们的目的是比较和评估依诺肝素和达比加群在轻微出血和软组织不良事件方面的发生率。
我们的准随机研究纳入了 122 名接受择期水泥固定初次 THR 的患者。根据围手术期使用的抗血栓形成药物将两组患者分组：依诺肝素组 61 例，达比加群组 61 例。记录大腿体积变化、计算围手术期失血量、血肿面积、伤口出血、伤口引流量和术后第 3 天和第 7 天的血清性伤口引流强度。
两组患者的血清性伤口引流的持续时间和强度差异有统计学意义。达比加群组引流去除后伤口引流量的持续时间为 2.2（±2.7）天，依诺肝素组为 1.2（±1.9）天（p < 0.05）。与依诺肝素组相比，达比加群组在术后第 3 天和第 7 天的血清性伤口引流显著增加（p < 0.05）。
两种抗血栓形成药物在 THR 后均具有适当的抗血栓形成作用。然而，达比加群与延长的血清性伤口引流发生率增加有关，这可能导致更长的住院时间，并可能促使延长抗生素预防。
