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静脉铁剂与安慰剂在心脏瓣膜手术后功能性缺铁性贫血患者管理中的比较:一项前瞻性、单盲、随机对照试验。

Intravenous Iron Versus Placebo in the Management of Postoperative Functional Iron Deficiency Anemia in Patients Undergoing Cardiac Valvular Surgery: A Prospective, Single-Blinded, Randomized Controlled Trial.

机构信息

Department of Adult Cardiac Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Science, Peking Union Medical College, Beijing, China.

Department of Adult Cardiac Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Science, Peking Union Medical College, Beijing, China.

出版信息

J Cardiothorac Vasc Anesth. 2019 Nov;33(11):2941-2948. doi: 10.1053/j.jvca.2019.01.063. Epub 2019 Feb 8.

DOI:10.1053/j.jvca.2019.01.063
PMID:30930140
Abstract

OBJECTIVE

To compare the efficacy of intravenous iron versus placebo to correct postoperative functional iron deficiency anemia in patients undergoing cardiac valvular surgery.

DESIGN

A prospective, single-blinded, randomized controlled study.

SETTING

National Center for Cardiovascular Diseases and a university hospital.

PARTICIPANTS

The study comprised 150 patients with postoperative functional iron deficiency anemia after cardiac valvular surgery.

INTERVENTIONS

The patients were randomly assigned (1:1) to either the treatment (intravenous iron) group or the control (placebo) group.

MEASUREMENTS AND MAIN RESULTS

The hemoglobin and ferritin concentrations and postoperative adverse events were collected and compared between the 2 groups. The hemoglobin concentration and the proportion of patients who had their anemia corrected or achieved hemoglobin increments of >20 g/L in the intravenous iron group were significantly higher than that in the placebo group at postoperative day 14 (p = 0.023, p = 0.037, and p = 0.001), whereas there was no statistical difference at postoperative day 7. The ferritin concentration was substantially higher at postoperative day 7 and postoperative day 14 in the intravenous iron group compared with the placebo group (both p < 0.001). There were no significant differences in rates of death, blood tranfusion, antibiotic upgrade, ventilator time >24 hours, postoperative hospital stay >10 days, poor wound healing, and perivalvular leakage between the 2 groups.

CONCLUSIONS

Intravenous iron could significantly increase the hemoglobin level in patients with postoperative functional iron deficiency anemia at postoperative day 14. However, there is no difference in blood transfusion requirements or postoperative adverse outcomes between the 2 groups.

摘要

目的

比较静脉铁剂与安慰剂在心脏瓣膜手术后纠正术后功能性缺铁性贫血的疗效。

设计

前瞻性、单盲、随机对照研究。

地点

国家心血管疾病中心和一所大学医院。

参与者

本研究纳入 150 例心脏瓣膜手术后出现术后功能性缺铁性贫血的患者。

干预措施

患者被随机(1:1)分配至治疗(静脉铁剂)组或对照组(安慰剂)。

测量和主要结果

收集并比较了两组患者的血红蛋白和铁蛋白浓度以及术后不良事件。静脉铁剂组患者的血红蛋白浓度和贫血纠正或血红蛋白增加>20 g/L 的患者比例在术后第 14 天显著高于安慰剂组(p=0.023,p=0.037 和 p=0.001),而在术后第 7 天则无统计学差异。静脉铁剂组患者的铁蛋白浓度在术后第 7 天和第 14 天均明显高于安慰剂组(均 p<0.001)。两组患者的死亡率、输血率、抗生素升级、呼吸机使用时间>24 小时、术后住院时间>10 天、伤口愈合不良和瓣周漏的发生率均无显著差异。

结论

静脉铁剂可显著提高术后功能性缺铁性贫血患者术后第 14 天的血红蛋白水平,但两组患者的输血需求或术后不良结局无差异。

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