Carless P A, Henry D A
Discipline of Clinical Pharmacology, School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.
Br J Surg. 2006 Jul;93(7):810-9. doi: 10.1002/bjs.5432.
The use of fibrin sealant has been proposed as a means of preventing seroma formation following breast cancer surgery. Conflicting trial results require the efficacy of fibrin sealant to be reviewed critically.
A systematic review of randomized controlled trials was conducted to examine the efficacy of fibrin sealants in reducing postoperative drainage and seroma formation after breast cancer surgery. Studies were identified by computer searches of Medline, Embase, the Cochrane Central Register of Controlled Trials and manufacturer websites (to June 2005), and bibliographic searches of published articles. Trials were eligible for inclusion if they reported data on postoperative drainage and the number of patients who developed a seroma.
Eleven trials met the criteria for inclusion. Generally, the trials were small and of poor methodological quality. Fibrin sealant did not reduce the rate of postoperative seroma (relative risk 1.14, 95 per cent confidence interval (c.i.) 0.88 to 1.46), the volume of drainage (weighted mean difference - 117.7, 95 per cent c.i. - 259.2 to 23.8 ml), or the length of hospital stay (weighted mean difference - 0.38, 95 per cent c.i. - 1.58 to 0.83 days).
The current evidence does not support the use of fibrin sealant in breast cancer surgery to reduce postoperative drainage or seroma formation.
有人提出使用纤维蛋白封闭剂作为预防乳腺癌手术后血清肿形成的一种方法。相互矛盾的试验结果要求对纤维蛋白封闭剂的疗效进行严格审查。
进行了一项随机对照试验的系统评价,以检验纤维蛋白封闭剂在减少乳腺癌手术后引流和血清肿形成方面的疗效。通过对Medline、Embase、Cochrane对照试验中央注册库和制造商网站(截至2005年6月)进行计算机检索,以及对已发表文章进行文献检索来确定研究。如果试验报告了术后引流数据和发生血清肿的患者数量,则符合纳入标准。
11项试验符合纳入标准。总体而言,这些试验规模较小且方法学质量较差。纤维蛋白封闭剂并未降低术后血清肿发生率(相对危险度1.14,95%可信区间(c.i.)0.88至1.46)、引流量(加权平均差-117.7,95% c.i.-259.2至23.8 ml)或住院时间(加权平均差-0.38,95% c.i.-1.58至0.83天)。
目前的证据不支持在乳腺癌手术中使用纤维蛋白封闭剂来减少术后引流或血清肿形成。