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术前口服与静脉铁剂治疗结直肠癌贫血患者的随机临床试验。

Randomized clinical trial of preoperative oral versus intravenous iron in anaemic patients with colorectal cancer.

机构信息

National Institute for Health Research Biomedical Research Unit in Gastrointestinal and Liver Diseases at Nottingham University Hospitals NHS Trust, University of Nottingham, Nottingham, UK.

Department of Colorectal Surgery, Nottingham University Hospitals NHS Trust, Nottingham, UK.

出版信息

Br J Surg. 2017 Feb;104(3):214-221. doi: 10.1002/bjs.10328. Epub 2017 Jan 16.

Abstract

BACKGROUND

Treatment of preoperative anaemia is recommended as part of patient blood management, aiming to minimize perioperative allogeneic red blood cell transfusion. No clear evidence exists outlining which treatment modality should be used in patients with colorectal cancer. The study aimed to compare the efficacy of preoperative intravenous and oral iron in reducing blood transfusion use in anaemic patients undergoing elective colorectal cancer surgery.

METHODS

Anaemic patients with non-metastatic colorectal adenocarcinoma were recruited at least 2 weeks before surgery and randomized to receive oral (ferrous sulphate) or intravenous (ferric carboxymaltose) iron. Perioperative changes in haemoglobin, ferritin, transferrin saturation and blood transfusion use were recorded until postoperative outpatient review.

RESULTS

Some 116 patients were included in the study. There was no difference in blood transfusion use from recruitment to trial completion in terms of either volume of blood administered (P = 0·841) or number of patients transfused (P = 0·470). Despite this, increases in haemoglobin after treatment were higher with intravenous iron (median 1·55 (i.q.r. 0·93-2·58) versus 0·50 (-0·13 to 1·33) g/dl; P < 0·001), which was associated with fewer anaemic patients at the time of surgery (75 versus 90 per cent; P = 0·048). Haemoglobin levels were thus higher at surgery after treatment with intravenous than with oral iron (mean 11·9 (95 per cent c.i. 11·5 to 12·3) versus 11·0 (10·6 to 11·4) g/dl respectively; P = 0·002), as were ferritin (P < 0·001) and transferrin saturation (P < 0·001) levels.

CONCLUSION

Intravenous iron did not reduce the blood transfusion requirement but was more effective than oral iron at treating preoperative anaemia and iron deficiency in patients undergoing colorectal cancer surgery.

摘要

背景

作为患者血液管理的一部分,建议治疗术前贫血,旨在最大限度地减少围手术期异体红细胞输血。目前尚无明确证据表明哪种治疗方式应用于结直肠癌患者。本研究旨在比较术前静脉和口服铁剂在减少择期结直肠癌手术贫血患者输血需求方面的疗效。

方法

在手术前至少 2 周招募患有非转移性结直肠腺癌的贫血患者,并随机分为口服(硫酸亚铁)或静脉(羧基麦芽糖铁)铁剂组。记录围手术期血红蛋白、铁蛋白、转铁蛋白饱和度和输血使用情况,直至术后门诊随访。

结果

本研究共纳入 116 例患者。就输注的血量(P = 0.841)或输血的患者数(P = 0.470)而言,从招募到试验完成,输血使用量无差异。尽管如此,静脉铁治疗后的血红蛋白增加量更高(中位数 1.55(四分位距 0.93-2.58)比 0.50(-0.13 至 1.33)g/dl;P < 0.001),这与手术时贫血患者数量减少有关(分别为 75%和 90%;P = 0.048)。因此,与口服铁相比,静脉铁治疗后手术时血红蛋白水平更高(分别为 11.9(95%可信区间 11.5 至 12.3)和 11.0(10.6 至 11.4)g/dl;P = 0.002),铁蛋白(P < 0.001)和转铁蛋白饱和度(P < 0.001)水平也是如此。

结论

静脉铁并未减少输血需求,但在治疗接受结直肠癌手术的患者的术前贫血和缺铁方面比口服铁更有效。

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