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术前静脉注射蔗糖铁以减少结直肠癌手术后贫血患者输血的随机临床试验。

Randomized clinical trial of preoperative intravenous iron sucrose to reduce blood transfusion in anaemic patients after colorectal cancer surgery.

作者信息

Edwards T J, Noble E J, Durran A, Mellor N, Hosie K B

机构信息

Department of Colorectal Surgery, Derriford Hospital, Plymouth, UK.

出版信息

Br J Surg. 2009 Oct;96(10):1122-8. doi: 10.1002/bjs.6688.

Abstract

BACKGROUND

The transfusion rate following colorectal cancer resection is between 10 and 30 per cent. Receipt of allogeneic blood is not without risk or cost. A preoperative adjunct that reduced the need for transfusion would mitigate these risks. This study was designed to determine whether iron sucrose reduces the likelihood of postoperative blood transfusion in patients undergoing elective colorectal cancer resection.

METHODS

In this randomized prospective blinded placebo-controlled trial of patients undergoing resectional surgery with a preoperative diagnosis of colorectal cancer, 600 mg iron sucrose or placebo was given intravenously in two divided doses, at least 24 h apart, 14 days before surgery. The primary outcome measures were serum haemoglobin concentration, recorded at recruitment, immediately before surgery and at discharge, and perioperative blood transfusions.

RESULTS

No difference was demonstrated between treatment groups (iron sucrose, 34 patients; placebo, 26) for any of the primary outcome measures, for either the whole study population or a subgroup of anaemic patients.

CONCLUSION

This pilot study provided no support for the use of intravenous iron sucrose as a preoperative adjunct to increase preoperative haemoglobin levels and thereby reduce the likelihood of allogeneic blood transfusion for patients undergoing resectional surgery for colorectal cancer.

REGISTRATION NUMBER

2005-003608-13UK (Medicines and Healthcare products Regulatory Agency).

摘要

背景

结直肠癌切除术后的输血率在10%至30%之间。接受异体输血并非没有风险或成本。一种能减少输血需求的术前辅助手段将降低这些风险。本研究旨在确定蔗糖铁是否能降低择期结直肠癌切除患者术后输血的可能性。

方法

在这项针对术前诊断为结直肠癌的接受切除手术患者的随机前瞻性双盲安慰剂对照试验中,在术前14天,将600毫克蔗糖铁或安慰剂分两次静脉注射,两次注射间隔至少24小时。主要观察指标为招募时、手术前即刻及出院时记录的血清血红蛋白浓度以及围手术期输血情况。

结果

对于整个研究人群或贫血患者亚组,在任何主要观察指标上,治疗组(蔗糖铁组34例患者;安慰剂组26例患者)之间均未显示出差异。

结论

这项初步研究不支持将静脉注射蔗糖铁作为术前辅助手段来提高术前血红蛋白水平,从而降低接受结直肠癌切除手术患者异体输血的可能性。

注册号

2005 - 003608 - 13UK(药品和医疗产品监管局)

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