异麦芽糖酐铁治疗缺铁性贫血可显著低磷血症的发生率
2020-02-11   阅读:273   来源:美国医学会杂志

奥地利因斯布鲁克医科大学Heinz Zoller联合美国杜克大学医学院Myles Wolf研究组比较了异麦芽糖酐铁与羧麦芽糖铁治疗缺铁性贫血对低磷血症的影响。这一研究成果发表在2020年2月4日出版的国际学术期刊《美国医学会杂志》上。

静脉注射铁可以快速纠正缺铁性贫血,但某些制剂会诱发成纤维细胞生长因子23介导的低磷血症。

为了比较异麦芽糖酐铁与羧麦芽糖铁对低磷血症风险、矿物质和骨稳态生物标记物的影响,2017年10月至2018年6月,研究组在美国的30个门诊点进行了两项设计相同、开放标签的随机临床试验,招募了245名缺铁性贫血的成人患者,这些患者口服铁1个月以上无效果。分别静脉注射异麦芽糖酐铁与羧麦芽糖铁。低磷血症定义为血清磷酸盐水平低于2.0mg/dL。

在试验A中,123名患者平均45.1岁,95.0%为女性,62名患者注射异麦芽糖酐铁,61名注射羧麦芽糖铁,95.1%的患者完成试验。在试验B中,122名患者平均年龄为42.6岁,94.1%为女性, 其中61名患者注射异麦芽糖酐铁,61名注射羧麦芽糖铁,93.4%的患者完成了试验。

治疗35天后,异麦芽糖酐铁组与羧麦芽糖铁组相比,低磷血症的发生率显著降低,试验组A分别为7.9%和75.0%,试验组B分别为8.1%和73.7%。除低磷血症和甲状旁腺激素增加外,最常见的不良反应是恶心和头痛,两组间均无差异。

总之,对于口服补铁无效的缺铁性贫血患者,静脉注射异麦芽糖酐铁与羧麦芽糖铁相比,35天后低磷血症的发生率显著降低。

附:英文原文

Title: Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia: Two Randomized Clinical Trials

Author: Myles Wolf, Janet Rubin, Maureen Achebe, Michael J. Econs, Munro Peacock, Erik A. Imel, Lars L. Thomsen, Thomas O. Carpenter, Thomas Weber, Vincent Brandenburg, Heinz Zoller

Issue&Volume: 2020/02/04

Abstract: 

Importance  Intravenous iron enables rapid correction of iron-deficiency anemia, but certain formulations induce fibroblast growth factor 23–mediated hypophosphatemia.
 
Objective  To compare risks of hypophosphatemia and effects on biomarkers of mineral and bone homeostasis of intravenous iron isomaltoside (now known as ferric derisomaltose) vs ferric carboxymaltose.
 
Design, Setting, and Participants  Between October 2017 and June 2018, 245 patients aged 18 years and older with iron-deficiency anemia (hemoglobin level ≤11 g/dL; serum ferritin level ≤100 ng/mL) and intolerance or unresponsiveness to 1 month or more of oral iron were recruited from 30 outpatient clinic sites in the United States into 2 identically designed, open-label, randomized clinical trials. Patients with reduced kidney function were excluded. Serum phosphate and 12 additional biomarkers of mineral and bone homeostasis were measured on days 0, 1, 7, 8, 14, 21, and 35. The date of final follow-up was June 19, 2018, for trial A and May 29, 2018, for trial B.
 
Interventions  Intravenous administration of iron isomaltoside, 1000 mg, on day 0 or ferric carboxymaltose, 750 mg, infused on days 0 and 7.
 
Main Outcomes and Measures  The primary end point was the incidence of hypophosphatemia (serum phosphate level <2.0 mg/dL) between baseline and day 35.
 
Results  In trial A, 123 patients were randomized (mean [SD] age, 45.1 [11.0] years; 95.9% women), including 62 to iron isomaltoside and 61 to ferric carboxymaltose; 95.1% completed the trial. In trial B, 122 patients were randomized (mean [SD] age, 42.6 [12.2] years; 94.1% women), including 61 to iron isomaltoside and 61 to ferric carboxymaltose; 93.4% completed the trial. The incidence of hypophosphatemia was significantly lower following iron isomaltoside vs ferric carboxymaltose (trial A: 7.9% vs 75.0% [adjusted rate difference, –67.0% {95% CI, –77.4% to –51.5%}], P?<?.001; trial B: 8.1% vs 73.7% [adjusted rate difference, –65.8% {95% CI, –76.6% to –49.8%}], P?<?.001). Beyond hypophosphatemia and increased parathyroid hormone, the most common adverse drug reactions (No./total No.) were nausea (iron isomaltoside: 1/125; ferric carboxymaltose: 8/117) and headache (iron isomaltoside: 4/125; ferric carboxymaltose: 5/117).
 
Conclusions and Relevance  In 2 randomized trials of patients with iron-deficiency anemia who were intolerant of or unresponsive to oral iron, iron isomaltoside (now called ferric derisomaltose), compared with ferric carboxymaltose, resulted in lower incidence of hypophosphatemia over 35 days. However, further research is needed to determine the clinical importance of this difference.

DOI: 10.1001/jama.2019.22450

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