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PREVENNT 研究:术前静脉铁剂治疗大型腹部手术前贫血的随机、双盲、对照试验:独立讨论。

The PREVENNT randomised, double-blind, controlled trial of preoperative intravenous iron to treat anaemia before major abdominal surgery: an independent discussion.

机构信息

William Harvey Research Institute, Queen Mary University of London, London, UK.

Department of Anaesthesia, Critical Care and Pain Medicine, Royal Infirmary of Edinburgh, Edinburgh, UK.

出版信息

Br J Anaesth. 2021 Jan;126(1):157-162. doi: 10.1016/j.bja.2020.08.053. Epub 2020 Oct 14.

Abstract

Anaemia is a common finding in patients presenting for major elective surgery and is associated with poor outcomes including death and complications. Iron deficiency is the leading cause of perioperative anaemia. Intravenous (i.v.) iron is considered to be an effective and safe treatment for iron deficiency anaemia and is recommended by expert opinion for treatment of preoperative anaemia, although evidence from clinical trials is lacking. The PREVENTT trial was a large multicentre trial investigating the effects of i.v. iron on red cell transfusion, death, complications and quality of life in 487 patients undergoing major abdominal surgery. The principal finding of this multicentre randomised placebo controlled trial was that there was no difference in the co-primary outcomes of blood transfusion or death, or the number of transfusion episodes, within 30 days after surgery, in patients that received preoperative i.v. iron therapy compared to placebo. The major inferential differences in this independent discussion relate to the limitations of the PREVENTT trial and its implications for future practice. Although PREVENTT represents the best evidence available to guide perioperative use of i.v. iron, it is likely that the study was underpowered. In the context of already widespread adoption of preoperative i.v. iron therapy, many clinicians may have felt they lacked equipoise. In light of the PREVENTT study routine use of i.v. iron in patients undergoing elective abdominal surgery cannot be recommended. Further research should define the optimum red cell transfusion strategy for patients undergoing surgery and idenify other surgical groups who may benefit from this intervention.

摘要

贫血是接受大型择期手术的患者常见的发现,与不良结局相关,包括死亡和并发症。缺铁是围手术期贫血的主要原因。静脉(i.v.)铁被认为是治疗缺铁性贫血的有效和安全方法,专家意见建议用于治疗术前贫血,尽管临床试验缺乏证据。PREVENTT 试验是一项大型多中心试验,研究了 487 例接受大型腹部手术的患者静脉铁对红细胞输血、死亡、并发症和生活质量的影响。这项多中心随机安慰剂对照试验的主要发现是,与安慰剂相比,接受术前静脉铁治疗的患者在手术后 30 天内输血或死亡的主要复合结局,或输血次数没有差异。本次独立讨论的主要推断差异与 PREVENTT 试验的局限性及其对未来实践的影响有关。尽管 PREVENTT 代表了指导围手术期使用静脉铁的最佳现有证据,但该研究可能没有足够的效力。在术前静脉铁治疗已广泛应用的背景下,许多临床医生可能认为自己缺乏平衡。鉴于 PREVENTT 研究,不能推荐常规在接受择期腹部手术的患者中使用静脉铁。进一步的研究应确定接受手术的患者最佳的红细胞输血策略,并确定其他可能受益于这种干预的手术群体。

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