Wang Chen, Han Zhe, Zhang Tao, Ma Jian-xiong, Jiang Xuan, Wang Ying, Ma Xin-long
Biomechanics Labs of Orthopaedics Institute, Tianjin Hospital, Tianjin, 300050, People's Republic of China.
Tianjin Medical University, Tianjin, 300070, People's Republic of China.
J Orthop Surg Res. 2014 Oct 15;9:90. doi: 10.1186/s13018-014-0090-7.
Total knee arthroplasty (TKA) is a popular procedure in severe osteoarthritis. But perioperative bleeding remains a problem. Floseal® is a mixture of thrombin and bovine gelatin which can benefit a lot on reducing intraoperative and postoperative bleeding. However, there is no enough evidence judging its safety and efficiency. So a meta-analysis is conducted by us to evaluate the efficacy and safety of a thrombin-based hemostatic agent compared with conventional methods in TKA.
Two independent reviewers selected literatures published before August 2014 from MEDLINE, Embase, and The Cochrane Central Register of Controlled Trials. Other internet databases were also performed to identify trials according to the Cochrane Collaboration guidelines. High-quality randomized controlled trials (RCTs), prospective control trials (PCTs), and case controlled trials (CCTs) were selected. The meta-analysis was undertaken using RevMan 5.1 for Windows.
Three RCTs, one PCT, and one CCT met the inclusion criteria. There were significant differences in hemoglobin decline and calculated total blood loss between the Floseal® group and control group. There were no significant differences in postoperative drainage volume, rate of transfusion requirement, incidence of wound infection, deep vein thrombosis (DVT), and pulmonary embolism (PE) between treatment and control groups.
The present meta-analysis indicates that a thrombin-based hemostatic agent can reduce hemoglobin decline and calculated total blood loss after TKA and is not related to adverse reactions or complications such as wound infection, DVT, and PE.
全膝关节置换术（TKA）是治疗重度骨关节炎的常用手术。但围手术期出血仍是一个问题。弗洛塞尔（Floseal®）是一种凝血酶和牛明胶的混合物，在减少术中及术后出血方面有很大益处。然而，尚无足够证据判断其安全性和有效性。因此，我们进行了一项荟萃分析，以评估基于凝血酶的止血剂与传统方法相比在TKA中的疗效和安全性。
两名独立评审员从MEDLINE、Embase和Cochrane对照试验中央注册库中筛选2014年8月之前发表的文献。还根据Cochrane协作指南在其他互联网数据库中检索相关试验。选取高质量的随机对照试验（RCT）、前瞻性对照试验（PCT）和病例对照试验（CCT）。使用RevMan 5.1 for Windows软件进行荟萃分析。
三项RCT、一项PCT和一项CCT符合纳入标准。弗洛塞尔（Floseal®）组与对照组在血红蛋白下降和计算得出的总失血量方面存在显著差异。治疗组与对照组在术后引流量、输血需求率、伤口感染发生率、深静脉血栓形成（DVT）和肺栓塞（PE）方面无显著差异。
本荟萃分析表明，基于凝血酶的止血剂可减少TKA术后血红蛋白下降和计算得出的总失血量，且与伤口感染、DVT和PE等不良反应或并发症无关。
