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随机临床试验:上消化道出血后口服与静脉铁剂治疗——一项安慰剂对照研究。

Randomised clinical trial: oral vs. intravenous iron after upper gastrointestinal haemorrhage--a placebo-controlled study.

机构信息

Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.

出版信息

Aliment Pharmacol Ther. 2014 Jan;39(2):176-87. doi: 10.1111/apt.12556. Epub 2013 Nov 19.

Abstract

BACKGROUND

Nonvariceal acute upper gastrointestinal bleeding (AUGIB) is often accompanied by post-discharge anaemia.

AIM

To investigate whether iron treatment can effectively treat anaemia and to compare a 3-month regimen of oral iron treatment with a single administration of intravenous iron prior to discharge.

METHODS

Ninety-seven patients with nonvariceal AUGIB and anaemia were enrolled in a double-blind, placebo-controlled, randomised study. The patients were allocated to one of three groups, receiving a single intravenous administration of 1000 mg of iron; oral iron treatment, 200 mg daily for 3 months; or placebo, respectively. The patients were followed up for 3 months.

RESULTS

From week 4 onwards, patients receiving treatment had significantly higher haemoglobin levels compared with patients who received placebo only. At the end of treatment, the proportion of patients with anaemia was significantly higher in the placebo group (P < 0.01) than in the treatment groups. Intravenous iron appeared to be more effective than oral iron in ensuring sufficient iron stores.

CONCLUSIONS

Iron treatment is effective and essential for treating anaemia after nonvariceal acute upper gastrointestinal bleeding. The route of iron supplementation is less important in terms of the increase in haemoglobin levels. Iron stores are filled most effectively if intravenous iron supplementation is administered (ClinicalTrials.gov identifier: NCT00978575).

摘要

背景

非静脉曲张性急性上消化道出血(AUGIB)常伴有出院后贫血。

目的

探讨铁剂治疗是否能有效治疗贫血,并比较出院前单次静脉铁剂治疗与 3 个月口服铁剂治疗的效果。

方法

97 例非静脉曲张性 AUGIB 合并贫血患者纳入一项双盲、安慰剂对照、随机研究。将患者分配至三组,分别接受单次静脉注射 1000mg 铁剂、每日口服 200mg 铁剂治疗 3 个月、或安慰剂治疗。患者随访 3 个月。

结果

从第 4 周开始,治疗组患者的血红蛋白水平明显高于仅接受安慰剂组的患者。治疗结束时,安慰剂组贫血患者的比例明显高于治疗组(P<0.01)。静脉铁似乎比口服铁更能有效地确保铁储存充足。

结论

铁剂治疗对非静脉曲张性急性上消化道出血后贫血的治疗是有效且必要的。铁补充途径对血红蛋白水平的升高影响不大。如果给予静脉铁补充,铁储存的补充效果最显著(ClinicalTrials.gov 标识符:NCT00978575)。

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