使用纤维蛋白封闭剂以尽量减少围手术期异体输血。
Fibrin sealant use for minimising peri-operative allogeneic blood transfusion.
作者信息
Carless P A, Henry D A, Anthony D M
机构信息
Discipline of Clinical Pharmacology, Faculty of Health, University of Newcastle, Level 5, Clinical Sciences Building, Newcastle Mater Hospital, Edith Street, Waratah, Newcastle, New South Wales, Australia.
出版信息
Cochrane Database Syst Rev. 2003;2003(2):CD004171. doi: 10.1002/14651858.CD004171.
BACKGROUND
Fibrin sealants have gained increasing popularity as interventions to improve peri-operative (intra/post-operative) haemostasis and diminish the need for allogeneic red cell transfusion (blood from an unrelated donor).
OBJECTIVES
To examine the efficacy of fibrin sealants in reducing peri-operative blood loss and allogeneic red blood cell (RBC) transfusion.
SEARCH STRATEGY
Studies were identified by: searches of MEDLINE, EMBASE, Current Contents, the Cochrane Library (July 2002), manufacturer web sites (to July 2002), and bibliographies of published articles.
SELECTION CRITERIA
Controlled trials in which adult patients, scheduled for elective surgery, were randomised to fibrin sealant treatment or to a control group who 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
Primary outcomes measured were: the number of patients exposed to allogeneic red cells, the amount of blood transfused, and blood loss. Other outcomes measured were: re-operation due to bleeding, infection, mortality, and length of hospital stay. Treatment effects were pooled using a random effects model.
MAIN RESULTS
Seven trials, including a total of 388 patients, reported data on peri-operative exposure to allogeneic RBC transfusion. Fibrin sealant treatment, on average, reduced the rate of exposure to allogeneic red cell transfusion by a relative 54% (relative risk [RR] = 0.46: 95%CI = 0.32 to 0.68). Eight trials, including a total of 442 patients, provided data for post-operative blood loss. Fibrin sealant treatment reduced blood loss on average by around 134 per patient (95%CI = 51 to 217 ). However the trials reviewed were small and of poor methodological quality (91% unblinded).
REVIEWER'S CONCLUSIONS: Overall the results suggest that fibrin sealants are efficacious in reducing both post-operative blood loss and peri-operative exposure to allogeneic RBC transfusion. However, due to the lack of blinding, transfusion practices may have been influenced by knowledge of the patient's treatment status. This raises concerns about the use of blood transfusion practice as an outcome variable in trials of fibrin sealant. In the case of blood loss, the results must be interpreted with caution, in view of the statistically significant heterogeneity in treatment effect observed. Large, methodologically rigorous, randomised controlled trials of fibrin sealants are needed.
背景
纤维蛋白封闭剂作为一种用于改善围手术期（术中/术后）止血并减少异体红细胞输注（来自无关供体的血液）需求的干预措施，越来越受到欢迎。
目的
研究纤维蛋白封闭剂在减少围手术期失血和异体红细胞（RBC）输注方面的疗效。
检索策略
通过以下途径识别研究：检索MEDLINE、EMBASE、《现刊目次》、Cochrane图书馆（2002年7月）、制造商网站（截至2002年7月）以及已发表文章的参考文献。
选择标准
针对计划进行择期手术的成年患者进行的对照试验，患者被随机分配至纤维蛋白封闭剂治疗组或未接受纤维蛋白封闭剂治疗的对照组。如果试验报告了关于接受异体红细胞输注的患者数量、输血量或失血量（客观评估）的数据，则该试验符合纳入标准。
数据收集与分析
测量的主要结局包括：接受异体红细胞的患者数量、输血量和失血量。测量的其他结局包括：因出血、感染、死亡率和住院时间而进行的再次手术。使用随机效应模型汇总治疗效果。
主要结果
七项试验，共纳入388例患者，报告了围手术期异体RBC输注的数据。纤维蛋白封闭剂治疗平均使异体红细胞输注的暴露率相对降低了54%（相对危险度[RR]=0.46：95%置信区间[CI]=0.32至0.68）。八项试验，共纳入442例患者，提供了术后失血量的数据。纤维蛋白封闭剂治疗平均使每位患者的失血量减少了约134（95%CI=51至217）。然而，所综述的试验规模较小且方法学质量较差（91%未设盲）。
综述作者结论
总体而言，结果表明纤维蛋白封闭剂在减少术后失血和围手术期异体RBC输注暴露方面是有效的。然而，由于缺乏设盲，输血操作可能受到了对患者治疗状态了解的影响。这引发了对在纤维蛋白封闭剂试验中使用输血操作作为结局变量的担忧。就失血量而言，鉴于观察到的治疗效果存在统计学上的显著异质性，对结果的解释必须谨慎。需要开展大规模、方法学严谨的纤维蛋白封闭剂随机对照试验。
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