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铁羧基麦芽糖铁或葡萄糖酸亚铁治疗炎症性肠病患者的低磷血症发生率。

Incidence of hypophosphatemia in patients with inflammatory bowel disease treated with ferric carboxymaltose or iron isomaltoside.

机构信息

Department of Gastroenterology, Akershus University Hospital, Lørenskog, Norway.

Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

出版信息

Aliment Pharmacol Ther. 2019 Aug;50(4):397-406. doi: 10.1111/apt.15386. Epub 2019 Jul 2.

Abstract

BACKGROUND

Iron deficiency and iron deficiency anaemia are common complications in inflammatory bowel disease (IBD). In patients with moderate-to-severe anaemia, oral iron intolerance or ineffectiveness of oral iron, ferric carboxymaltose and iron isomaltoside are widely used. Hypophosphatemia is a side effect of both preparations.

AIMS

To investigate the occurrence of hypophosphatemia in IBD patients with iron deficiency/iron deficiency anaemia treated with high-dose intravenous iron.

METHODS

A prospective observational study of adult IBD patients with iron deficiency/iron deficiency anaemia was conducted at two study sites where patients received 1000 mg of ferric carboxymaltose or iron isomaltoside. At baseline, weeks 2 and 6, blood and faecal samples were collected. The primary endpoint was to determine the incidence of moderate-to-severe hypophosphatemia. Secondary endpoints included the total incidence of hypophosphatemia, possible risk factors for hypophosphatemia, and response to single-dose intravenous iron.

RESULTS

One hundred and thirty patients were included. In the per-protocol set, 52 patients received ferric carboxymaltose and 54 patients received iron isomaltoside. Ferric carboxymaltose treatment had a significantly higher incidence of moderate-to-severe hypophosphatemia compared with iron isomaltoside at week 2 (56.9% vs 5.7%, P < 0.001) and a higher incidence at week 6 (13.7% vs 1.9%, P = 0.054).The overall incidence of hypophosphatemia was significantly higher with ferric carboxymaltose compared with iron isomaltoside treatment at weeks 2 (72.5% vs 11.3%, P < 0.001) and 6 (21.6% vs 3.7%, P = 0.013).

CONCLUSIONS

In IBD patients with iron deficiency/iron deficiency anaemia, ferric carboxymaltose was associated with higher incidence, severity and persistence of hypophosphatemia compared with iron isomaltoside. The presence of moderate-to-severe hypophosphatemia beyond 6 weeks is a clinical concern that requires further investigation.

摘要

背景

缺铁和缺铁性贫血是炎症性肠病(IBD)的常见并发症。在中重度贫血患者中,口服铁不耐受或口服铁无效时,广泛使用羧基麦芽糖铁和异麦芽糖铁。这两种制剂的副作用都包括低磷血症。

目的

研究静脉给予高剂量铁剂治疗缺铁/缺铁性贫血的 IBD 患者发生低磷血症的情况。

方法

在两个研究点进行了一项前瞻性观察性研究,纳入了患有缺铁/缺铁性贫血的成年 IBD 患者,这些患者接受 1000mg 羧基麦芽糖铁或异麦芽糖铁治疗。在基线、第 2 周和第 6 周采集血样和粪便样本。主要终点是确定中重度低磷血症的发生率。次要终点包括低磷血症的总发生率、低磷血症的可能危险因素以及单次静脉铁剂治疗的反应。

结果

共纳入 130 例患者。在符合方案集(per-protocol set)中,52 例患者接受羧基麦芽糖铁治疗,54 例患者接受异麦芽糖铁治疗。与异麦芽糖铁相比,羧基麦芽糖铁治疗在第 2 周(56.9%比 5.7%,P<0.001)和第 6 周(13.7%比 1.9%,P=0.054)时发生中重度低磷血症的比例显著更高。与异麦芽糖铁治疗相比,羧基麦芽糖铁治疗在第 2 周(72.5%比 11.3%,P<0.001)和第 6 周(21.6%比 3.7%,P=0.013)时低磷血症的总发生率显著更高。

结论

在缺铁/缺铁性贫血的 IBD 患者中,与异麦芽糖铁相比,羧基麦芽糖铁更易引起低磷血症的发生、严重程度和持续时间。6 周后出现中重度低磷血症是一个临床关注问题,需要进一步研究。

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