Department of Orthopedics and Rheumatology, University Hospital Marburg, Marburg, Germany.
Clin Orthop Relat Res. 2014 Jan;472(1):272-6. doi: 10.1007/s11999-013-3036-1.
Bleeding remains an ongoing concern after total knee arthroplasty (TKA). Intraarticular application of human fibrinogen with a topical thrombin has been described to stop diffuse bleeding in knee arthroplasty.
QUESTIONS/PURPOSES: It was hypothesized that the use of human fibrinogen as a topical agent would result in a reduction of bleeding and transfusions required after TKA; secondary end points included comparison of early clinical results including pain scores and range of motion (ROM) at 6 weeks and complications after surgery.
Two hundred patients undergoing TKA were randomized into a double-blind clinical trial to receive either intraarticular fibrinogen 2 minutes before tourniquet release or no such treatment. Postoperative hemoglobin and hematocrit levels, drain output, and transfusion requirements were recorded and blood loss was calculated. Clinical outcomes and adverse events were tracked prospectively. Descriptive analysis was performed using a two-sample t-test.
There were no differences in calculated blood loss between the fibrinogen and the control groups; the mean postoperative drain output was 780 ± 378 mL in the fibrinogen group compared with 673 ± 301 mL in the control group (p = 0.029), but the hemoglobin drop at Day 2 was 3.47 ± 1.53 g/L in the fibrinogen group and 3.84 ± 1.24 g/Ll in the control group (p = 0.051). There were no differences in in transfusions, early ROM, visual analog pain scores, or complications between the groups.
The use of fibrinogen in TKA did not lead to a significant reduction of blood loss or transfusions in primary TKA for osteoarthritis. Given the lack of benefits and the costs this procedure adds to TKA, its routine use cannot be justified during primary TKA for osteoarthritis.
全膝关节置换术（TKA）后仍存在出血问题。关节内应用人纤维蛋白原加局部凝血酶已被描述为可停止膝关节置换术中的弥漫性出血。
问题/目的：假设将人纤维蛋白原作为局部制剂使用将减少 TKA 后所需的出血和输血；次要终点包括比较术后 6 周的早期临床结果，包括疼痛评分和活动范围（ROM）以及手术后的并发症。
200 例接受 TKA 的患者被随机分为双盲临床试验，在止血带释放前 2 分钟接受关节内纤维蛋白原或不接受此类治疗。记录术后血红蛋白和血细胞比容水平、引流量和输血需求，并计算失血量。前瞻性跟踪临床结果和不良事件。使用两样本 t 检验进行描述性分析。
纤维蛋白原组和对照组的计算失血量无差异；纤维蛋白原组术后引流量平均为 780 ± 378 mL，对照组为 673 ± 301 mL（p = 0.029），但纤维蛋白原组第 2 天的血红蛋白下降为 3.47 ± 1.53 g/L，对照组为 3.84 ± 1.24 g/L（p = 0.051）。两组间输血、早期 ROM、视觉模拟疼痛评分或并发症均无差异。
在原发性骨关节炎 TKA 中，纤维蛋白原的使用并未导致出血量或输血量显著减少。鉴于缺乏益处且该程序增加了 TKA 的成本，因此不能在原发性骨关节炎 TKA 中常规使用。
