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[Lancet发表论文]:超短程治疗对接受心脏手术的缺铁或贫血患者的疗效:一项前瞻随机对照试验
2019年06月15日 时讯速递, 进展交流 暂无评论

Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery: a prospective randomised trial

Donat R Spahn, Felix Schoenrath, Gabriela H Spahn, et al

Lancet 2019; 393: 2201-2212 DOI:https://doi.org/10.1016/S0140-6736(18)32555-8

Summary

Background 背景

Anaemia and iron deficiency are frequent in patients scheduled for cardiac surgery. This study assessed whether immediate preoperative treatment could result in reduced perioperative red blood cell (RBC) transfusions and improved outcome.

贫血及缺铁在择期心脏手术患者非常普遍。本研究评估术前即刻治疗能否减少围手术期输注红细胞(RBC)并改善患者预后。

Methods 方法

In this single-centre, randomised, double-blind, parallel-group controlled study, patients undergoing elective cardiac surgery with anaemia (n=253; haemoglobin concentration (Hb) <120 g/L in women and Hb <130 g/L in men) or isolated iron deficiency (n=252; ferritin <100 mcg/L, no anaemia) were enrolled. Participants were randomly assigned (1:1) with the use of a computer-generated range minimisation (allocation probability 0·8) to receive either placebo or combination treatment consisting of a slow infusion of 20 mg/kg ferric carboxymaltose, 40 000 U subcutaneous erythropoietin alpha, 1 mg subcutaneous vitamin B12, and 5 mg oral folic acid or placebo on the day before surgery. Primary outcome was the number of RBC transfusions during the first 7 days. This trial is registered with ClinicalTrials.gov, number NCT02031289.

这是一项单中心、随机、双盲、平行对照研究,接受择期心脏手术且合并贫血(n=253; 女性血红蛋白水平 (Hb) <120 g/L,男性Hb <130 g/L in men)或单纯缺铁(n=252; 铁蛋白< 100 mcg/L,无贫血)的患者入选。入选患者按照1:1的比例根据计算机产生的范围最小化(分配概率0.8)随机分组,术前一天分别接受安慰剂或联合治疗(缓慢输注20 mg/kg羧麦芽糖铁,皮下注射40 000 U EPO,皮下注射1 mg维生素B12,口服5 mg叶酸)。主要预后终点为最初7天内输注RBC数目。试验在ClinicalTrials.gov网站注册,注册号NCT02031289

Findings 结果

Between Jan 9, 2014, and July 19, 2017, 1006 patients were enrolled; 505 with anaemia or isolated iron deficiency and 501 in the registry. The combination treatment significantly reduced RBC transfusions from a median of one unit in the placebo group (IQR 0–3) to zero units in the treatment group (0–2, during the first 7 days (odds ratio 0·70 [95% CI 0·50–0·98] for each threshold of number of RBC transfusions, p=0·036) and until postoperative day 90 (p=0·018). Despite fewer RBC units transfused, patients in the treatment group had a higher haemoglobin concentration, higher reticulocyte count, and a higher reticulocyte haemoglobin content during the first 7 days (p≤0·001). Combined allogeneic transfusions were less in the treatment group (0 [IQR 0–2]) versus the placebo group (1 [0–3]) during the first 7 days (p=0·038) and until postoperative day 90 (p=0·019). 73 (30%) serious adverse events were reported in the treatment group group versus 79 (33%) in the placebo group.

2014年1月9日至2017年7月19日间,共入选1006名患者;包括505名贫血及501名单纯贫血患者。安慰剂组中位数为1个单位(IQR 0–3),治疗组中位数为0个单位(0–2),联合治疗显著减少最初7天内(比数比0·70 [95% CI 0·50–0·98],p=0·036)及术后90天内(p=0·018)输注RBC风险。尽管输注RBC更少,治疗组患者最初7天内血红蛋白水平、网织红细胞计数及网织红细胞血红蛋白水平更高(p≤0·001)。最初7天内(p=0.038)及术后90天内(p=0.019)治疗组所有异基因输血显著减少(0 [IQR 0–2]) vs. 安慰剂组(1 [0–3])。治疗组73例患者 (30%) 及安慰剂组79例患者报告严重不良事件。

Interpretation 结论

An ultra-short-term combination treatment with intravenous iron, subcutaneous erythropoietin alpha, vitamin B12, and oral folic acid reduced RBC and total allogeneic blood product transfusions in patients with preoperative anaemia or isolated iron deficiency undergoing elective cardiac surgery.

对于接受择期心脏手术且术前合并贫血或单纯缺铁的患者,静脉铁剂、皮下EPO、维生素B12及口服叶酸的超短程联合治疗能够减少RBC及所有异基因血液制品的输注。

Funding

Vifor Pharma and Swiss Foundation for Anaesthesia Research.

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