Royal National Orthopaedic Hospital, Stanmore, Middlesex, UK.
Acta Orthop. 2011 Dec;82(6):660-3. doi: 10.3109/17453674.2011.623568. Epub 2011 Oct 17.
Previous studies have shown that either fibrin spray or tranexamic acid can reduce blood loss at total hip replacement, but the 2 treatments have not been directly compared. We therefore conducted a randomized, controlled trial.
In this randomized controlled trial we compared the effect of tranexamic acid and fibrin spray on blood loss in cemented total hip arthroplasty. 66 patients were randomized to 1 of 3 parallel groups receiving (1) a 10 mg/kg bolus of tranexamic acid prior to surgery, (2) 10 mL of fibrin spray during surgery, or (3) neither. All participants except the surgeon were blinded as to treatment group until data analysis was complete. Blood loss was calculated from preoperative and postoperative hematocrit.
Neither active treatment was found to be superior to the other in terms of overall blood loss. Losses were lower than those in the control group, when using either tranexamic acid (22% lower, p = 0.02) or fibrin spray (32% lower, p = 0.02).
We found that the use of tranexamic acid at induction, or topical fibrin spray intraoperatively, reduced blood loss compared to the control group. Blood loss was similar in the fibrin spray group and in the tranexamic acid group. ClinicalTrials.gov identifier: NCT00378872. EudraCT identifier: 2006-001299-19. Regional Ethics Committee approval: 06/S0703/55, granted June 6, 2006.
先前的研究表明，纤维蛋白喷雾或氨甲环酸均可减少全髋关节置换术的失血量，但这两种治疗方法尚未进行直接比较。因此，我们进行了一项随机对照试验。
在这项随机对照试验中，我们比较了氨甲环酸和纤维蛋白喷雾对骨水泥全髋关节置换术失血的影响。将 66 例患者随机分为 3 组：（1）手术前给予 10mg/kg 氨甲环酸推注，（2）手术中给予 10ml 纤维蛋白喷雾，或（3）两者均不给予。除外科医生外，所有参与者均对治疗组进行了盲法，直到数据分析完成。失血量根据术前和术后的血细胞比容计算。
在总体失血量方面，两种积极的治疗方法都没有比其他方法更优越。与对照组相比，使用氨甲环酸（降低 22%，p=0.02）或纤维蛋白喷雾（降低 32%，p=0.02）均可降低失血量。
我们发现，与对照组相比，诱导时使用氨甲环酸或术中局部应用纤维蛋白喷雾可减少失血量。纤维蛋白喷雾组和氨甲环酸组的失血量相似。临床试验注册号：NCT00378872。EudraCT 注册号：2006-001299-19。区域伦理委员会批准：06/S0703/55，2006 年 6 月 6 日批准。
