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骨科大手术中的血液保护策略:疗效、安全性和欧洲法规。

Blood conservation strategies in major orthopaedic surgery: efficacy, safety and European regulations.

机构信息

GIEMSA, Medicina Transfusional, University of Málaga, Málaga, Spain.

出版信息

Vox Sang. 2009 Jan;96(1):1-13. doi: 10.1111/j.1423-0410.2008.01108.x.

DOI:10.1111/j.1423-0410.2008.01108.x
PMID:19121192
Abstract

Several major orthopaedic surgical procedures may result in significant blood loss and the need for allogeneic blood transfusion (ABT). However, overall concerns about adverse effects of ABT have prompted the review of transfusion practice and the search for transfusion alternatives to decrease or avoid the use of ABT. These strategies include the correction of perioperative anaemia, pharmacological and non-pharmacologic measures to reduce blood loss, preoperative autologous blood donation and perioperative red blood cell salvage. We have reviewed the efficacy and safety of these strategies and where appropriate offer evidence-based recommendations on their use in orthopaedic surgery. We also reviewed the European regulations on ABT alternatives. Pharmacological alternatives need to be used with a total adherence to European regulations in their legal and off-label use. The administration and use of pharmacological agents to stimulate erythropoiesis or reduce blood loss needs to be within the context of attempting to use allogenic blood in a rational manner. As for autologous blood, European Directives cover preoperative autologous blood donation, but not its clinical use, and perioperative red blood cell salvage devices, but not the product yielded by them. Therefore, the development of quality standards and good practice guidelines for perioperative red blood cell salvage, as well as its inclusion in the haemovigilance programme, is urgently needed. Finally, it is noteworthy that some recommendations given for ABT alternatives are not supported by a high level of evidence and that the goal of performing major orthopaedic surgical procedures without the use of ABT may be better accomplished by combining several of these techniques within a defined algorithm.

摘要

几种主要的骨科手术可能导致大量失血和需要异体输血(ABT)。然而,人们对 ABT 的不良反应的总体担忧促使人们审查输血实践,并寻找输血替代品,以减少或避免使用 ABT。这些策略包括纠正围手术期贫血、减少失血的药物和非药物措施、术前自体献血和围手术期红细胞回收。我们已经审查了这些策略的疗效和安全性,并在适当的情况下就其在骨科手术中的应用提供了基于证据的建议。我们还审查了欧洲关于 ABT 替代品的规定。药物替代品需要在其法律和标签外使用方面完全遵守欧洲法规。使用药物来刺激红细胞生成或减少失血,需要在合理使用异体血的背景下进行。至于自体血,欧洲指令涵盖了术前自体献血,但不包括其临床使用,以及围手术期红细胞回收装置,但不包括它们产生的产品。因此,迫切需要制定围手术期红细胞回收的质量标准和良好实践指南,并将其纳入血液监测计划。最后,值得注意的是,一些替代 ABT 的建议没有得到高水平证据的支持,并且在不使用 ABT 的情况下进行主要骨科手术的目标可能通过在一个定义的算法中结合几种这些技术来更好地实现。

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