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静脉注射铁剂不能有效纠正心脏手术患者术前贫血:一项前瞻性随机对照试验。

Intravenous iron does not effectively correct preoperative anaemia in cardiac surgery: a pilot randomized controlled trial.

作者信息

Padmanabhan Hari, Siau Keith, Nevill Alan M, Morgan Ian, Cotton James, Ng Alex, Brookes Matthew J, Luckraz Heyman

机构信息

Department of Gastroenterology, Royal Wolverhampton NHS Trust, Wolverhampton, UK.

Faculty of Education, Health and Wellbeing, University of Wolverhampton, Wolverhampton, UK.

出版信息

Interact Cardiovasc Thorac Surg. 2019 Mar 1;28(3):447-454. doi: 10.1093/icvts/ivy226.

DOI:10.1093/icvts/ivy226
PMID:30107449
Abstract

OBJECTIVES

Preoperative anaemia is a strong predictor of blood transfusion requirements and must be assessed for appropriate optimization before elective surgery. Iron therapy is a transfusion-sparing approach effective for increasing haemoglobin concentrations. However, its role in elective cardiac surgery and the optimal route of administration remain unknown. This single-centre, non-blinded, randomized, controlled trial compared the effectiveness of intravenous ferric carboxymaltose therapy with oral iron for anaemic patients undergoing elective cardiac surgery.

METHODS

Fifty anaemic patients scheduled for elective cardiac surgery were randomized to receive either oral or intravenous iron therapy 3-8 weeks preoperatively. Changes in haemoglobin concentration were measured. Blood transfusion and postoperative outcome data were collected.

RESULTS

Preoperative median increases in haemoglobin were 1.0 g/l (interquartile range -3.25 to 7.25 g/l) and 3.0 g/l (interquartile range -1.25 to 6.25 g/l) for patients receiving intravenous and oral iron, respectively (P = 0.42). The median first 12-h blood loss was significantly higher in the intravenous group (655 ml; interquartile range 162-1540 ml) compared to the oral group (313 ml; interquartile range 150-1750 ml; P < 0.007). Median increments in serum ferritin were superior for the intravenous group (median difference 313 µg/l; interquartile range 228-496) compared to the oral group (median difference 5.5 µg/l; interquartile range -1.4 to 19.4; P < 0.001).

CONCLUSIONS

Increases in ferritin after intravenous iron administration were significantly greater than those after oral iron administration. There was no significant difference in haemoglobin increments between groups. Despite significantly higher intraoperative blood loss in the group receiving intravenous iron, blood transfusion requirements for both groups were not statistically different.

CLINICAL TRIAL REGISTRATION

ISRCTN22158788.

摘要

目的

术前贫血是输血需求的一个强有力预测指标,在择期手术前必须对其进行评估以进行适当优化。铁剂治疗是一种增加血红蛋白浓度的有效减少输血的方法。然而,其在择期心脏手术中的作用及最佳给药途径仍不明确。这项单中心、非盲、随机对照试验比较了静脉注射羧基麦芽糖铁疗法与口服铁剂对择期心脏手术贫血患者的有效性。

方法

50例计划进行择期心脏手术的贫血患者被随机分为两组,在术前3 - 8周分别接受口服或静脉铁剂治疗。测量血红蛋白浓度的变化。收集输血及术后结局数据。

结果

接受静脉铁剂和口服铁剂的患者术前血红蛋白的中位数增加值分别为1.0 g/l(四分位间距 -3.25至7.25 g/l)和3.0 g/l(四分位间距 -1.25至6.25 g/l)(P = 0.42)。静脉组术后前12小时的中位数失血量(655 ml;四分位间距162 - 1540 ml)显著高于口服组(313 ml;四分位间距150 - 1750 ml;P < 0.007)。静脉组血清铁蛋白的中位数增加值(中位数差值313 μg/l;四分位间距228 - 496)优于口服组(中位数差值5.5 μg/l;四分位间距 -1.4至19.4;P < 0.001)。

结论

静脉注射铁剂后铁蛋白的增加显著大于口服铁剂后。两组之间血红蛋白增加值无显著差异。尽管接受静脉铁剂治疗的组术中失血量显著更高,但两组的输血需求在统计学上无差异。

临床试验注册号

ISRCTN22158788。

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