Fibrin sealants (also referred to as biological glue or fibrin tissue adhesives) have gained increasing popularity as interventions to improve peri-operative (intra- and post-operative) haemostasis and diminish the need for allogeneic red cell transfusion (blood from an unrelated donor).
To examine the efficacy of fibrin sealants in reducing peri-operative blood loss and allogeneic red blood cell (RBC) transfusion.
We identified studies by searching CENTRAL (The Cochrane Library 2007, Issue 3), MEDLINE (1950 to 2008), EMBASE (1980 to 2008), manufacturer web sites (to March 2008), and bibliographies of relevant published articles.
Controlled trials in which adult patients scheduled for elective surgery were randomised to fibrin sealant treatment or to a control group which did not receive fibrin sealant treatment. Trials were eligible if they reported data on the number of patients exposed to allogeneic red cell transfusion, the volume of blood transfused, or blood loss (assessed objectively).
Data collection and analysis
The primary outcomes measured were the: number of patients exposed to allogeneic red cells, amount of blood transfused, and blood loss. Other outcomes measured were: re-operation due to bleeding, infection, mortality, thrombotic events, and length of hospital stay. Treatment effects were pooled using a random-effects model.
Eighteen trials that included a total of 1406 patients reported data on peri-operative exposure to allogeneic RBC transfusion. Fibrin sealant treatment, on average, reduced the rate of exposure to allogeneic RBC transfusion by a relative 37% (relative risk (RR) 0.63, 95% confidence interval (CI) 0.45 to 0.88) and 7% in absolute terms (95% CI 2% to 13%). Fourteen trials, including a total of 853 patients, provided data for post-operative blood loss. In aggregate, fibrin sealant treatment reduced blood loss on average by around 161 ml per patient (95% CI 98.25 to 224.53 ml). In the context of orthopaedic surgery, fibrin sealant treatment reduced post-operative blood loss on average by around 223 ml per patient (95% CI 119.85 to 325.18 ml) and reduced the risk of exposure to allogeneic RBC transfusion by 32% (RR 0.68, 95% CI 0.51 to 0.89). Fibrin sealant treatment was not associated with an increased risk of wound infection (RR 0.61, 95% CI 0.24 to 1.58), any infection (RR 0.93, 95% CI 0.44 to 1.94), haematoma formation (RR 0.46, 95% CI 0.18 to 1.18), or death (RR 0.85, 95% CI 0.38 to 1.89). Hospital length of stay was not reduced in patients treated with fibrin sealant (weighted mean difference (WMD) -0.21 days, 95% CI -0.42 to 0.01 days).
Overall, the results suggest that fibrin sealants are efficacious in reducing both post-operative blood loss and peri-operative exposure to allogeneic RBC transfusion. Although treatment-effect heterogeneity was observed for these primary efficacy outcomes, heterogeneity was generally in terms of the size of effect rather than the direction of effect. Fibrin sealants appeared to demonstrate their greatest beneficial effects in the context of orthopaedic surgery, where blood loss is often substantial. Trials not involving orthopaedic surgery generally showed a trend toward decreased post-operative blood loss but the observed reductions were not clinically significant. The majority of trials included in this review were small, which raises concerns about the potential effects of publication bias. Funnel plot assessment indicates that there is some evidence of publication bias in the form of a missing population of small negative trials. We believe that large, methodologically rigorous, randomised controlled trials of fibrin sealants are needed.
檢索以下的資料庫來確定相關的研究：MEDLINE，EMBASE，Current Contents，the Cochrane Library (2002年7月)，製造商的網頁(至2002年7月)，以及發表文章的參考書目。
七項試驗，總共包括388位病患，報告的資料有在手術期間接受異體紅血球細胞輸血。纖維蛋白密封膠治療，平均相對減少54%接受異體紅血球細胞輸血的比率(relative risk [RR] = 0.46: 95%CI = 0.32至0.68)。8項試驗，總共包括442位病患，提供的資料有手術後失血。纖維蛋白密封膠治療平均減少每名病患約134c.c的失血量(95%CI = 51至217)。然而，回顧的試驗是小型的且方法學的品質不佳(91%為非盲目試驗)。
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。