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贫血患者腹部大手术前接受静脉注射铁剂并不能降低输血需求
作者:小柯机器人 发布时间:2020/9/12 13:37:06

澳大利亚菲奥娜·斯坦利医院Toby Richards团队研究了贫血患者腹部大手术术前静脉注射铁剂对术后输血量的影响。2020年9月4日,该研究发表在《柳叶刀》杂志上。

择期大手术患者中有很多术前贫血,且与不良预后相关。

为了验证腹腔手术前给贫血患者静脉注射铁剂是否可以纠正贫血,减少输血需求,并改善患者预后,研究组进行了一项双盲、平行组、随机试验。2014年1月6日至2018年9月28日,研究组在英国46个三级治疗中心招募了487名择期行大开腹术的贫血患者。贫血定义为男性血红蛋白低于130 g/L,女性血红蛋白低于120 g/L。将参与者按1:1随机分组,其中244名在术前10-42天接受静脉输注铁剂治疗,243名接受静脉输注生理盐水。

共有474名参与者完成试验并进入最终分析。安慰剂组237名患者中有67名(28%)死亡或需要输血,静脉输注铁剂组237例患者中有69例(29%),风险比为1.03。安慰剂组有111例患者接受了输血,静脉注射铁剂组有105例,比值比为0.98。两组患者在任何预先指定的安全终点上均无显著差异。

总之,对于择期重大开腹手术的贫血患者而言,术前10-42天静脉输注铁剂,与安慰剂相比并不能减少输血需求。

附:英文原文

Title: Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT): a randomised, double-blind, controlled trial

Author: Toby Richards, Ravishankar Rao Baikady, Ben Clevenger, Anna Butcher, Sandy Abeysiri, Marisa Chau, Iain C Macdougall, Gavin Murphy, Rebecca Swinson, Tim Collier, Laura Van Dyck, John Browne, Andrew Bradbury, Matthew Dodd, Richard Evans, David Brealey, Stefan D Anker, Andrew Klein

Issue&Volume: 2020-09-04

Abstract:

Background

Preoperative anaemia affects a high proportion of patients undergoing major elective surgery and is associated with poor outcomes. We aimed to test the hypothesis that intravenous iron given to anaemic patients before major open elective abdominal surgery would correct anaemia, reduce the need for blood transfusions, and improve patient outcomes.

Methods

In a double-blind, parallel-group randomised trial, we recruited adult participants identified with anaemia at preoperative hospital visits before elective major open abdominal surgery at 46 UK tertiary care centres. Anaemia was defined as haemoglobin less than 130 g/L for men and 120 g/L for women. We randomly allocated participants (1:1) via a secure web-based service to receive intravenous iron or placebo 10–42 days before surgery. Intravenous iron was administered as a single 1000 mg dose of ferric carboxymaltose in 100 mL normal saline, and placebo was 100 mL normal saline, both given as an infusion over 15 min. Unblinded study personnel prepared and administered the study drug; participants and other clinical and research staff were blinded to treatment allocation. Coprimary endpoints were risk of the composite outcome of blood transfusion or death, and number of blood transfusions from randomisation to 30 days postoperatively. The primary analysis included all randomly assigned patients with data available for the primary endpoints; safety analysis included all randomly assigned patients according to the treatment received. This study is registered, ISRCTN67322816, and is closed to new participants.

Findings

Of 487 participants randomly assigned to placebo (n=243) or intravenous iron (n=244) between Jan 6, 2014, and Sept 28, 2018, complete data for the primary endpoints were available for 474 (97%) individuals. Death or blood transfusion occurred in 67 (28%) of the 237 patients in the placebo group and 69 (29%) of the 237 patients in the intravenous iron group (risk ratio 1·03, 95% CI 0·78–1·37; p=0·84). There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group (rate ratio 0·98, 95% CI 0·68–1·43; p=0·93). There were no significant differences between the two groups for any of the prespecified safety endpoints.

Interpretation

Preoperative intravenous iron was not superior to placebo to reduce need for blood transfusion when administered to patients with anaemia 10–42 days before elective major abdominal surgery.

DOI: 10.1016/S0140-6736(20)31539-7

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31539-7/fulltext

期刊信息

LANCET:《柳叶刀》,创刊于1823年。隶属于爱思唯尔出版社,最新IF:59.102
官方网址:http://www.thelancet.com/
投稿链接:http://ees.elsevier.com/thelancet