乳铁蛋白治疗炎症性肠病儿童缺铁性贫血的临床试验
Lactoferrin for iron-deficiency anemia in children with inflammatory bowel disease: a clinical trial.
机构信息
Pediatric Department, Faculty of Medicine, Tanta University, Tanta, Egypt.
Department of Clinical Pharmacy, Faculty of Pharmacy, Tanta University, Tanta, Egypt.
出版信息
Pediatr Res. 2022 Sep;92(3):762-766. doi: 10.1038/s41390-022-02136-2. Epub 2022 Jun 9.
BACKGROUND
Iron-deficiency anemia (IDA) is common in children with inflammatory bowel disease (IBD); however, oral iron supplements are commonly associated with poor compliance due to gastrointestinal side effects. We compared the effect of lactoferrin versus oral ferrous sulfate for the treatment of IDA in children with IBD.
METHODS
Ninety-two IBD children with IDA were included but only 80 children completed the study and they were randomized into two groups: ferrous sulfate group (n = 40) who received ferrous sulfate 6 mg/kg/day for 3 months and lactoferrin group (n = 40) who received lactoferrin 100 mg/day for 3 months. Complete blood count, serum iron, total iron-binding capacity (TIBC), transferrin saturation (TS), serum ferritin, interleukin-6 (IL-6), and hepcidin 25 were measured before and after the treatment.
RESULTS
Hemoglobin (Hb), mean corpuscular volume, serum iron, TS, and serum ferritin significantly increased, while TIBC decreased significantly after the administration of either ferrous sulfate or lactoferrin compared to their baseline data. In addition, lactoferrin significantly increased Hb, serum iron, TS, and serum ferritin compared to ferrous sulfate. Moreover, lactoferrin significantly decreased IL-6 and hepcidin levels.
CONCLUSION
Lactoferrin is a promising effective treatment with fewer side effects than oral elemental iron in children with IBD and IDA.
CLINICAL TRIAL REGISTRATION
The study was registered at www.pactr.org (PACTR202002763901803).
IMPACT
Iron-deficiency anemia (IDA) in children with inflammatory bowel disease (IBD) is treated with oral iron therapy; however, oral iron supplements are commonly associated with poor compliance due to gastrointestinal side effects. To the best of our knowledge, our study was the first in pediatrics that compared the effect of lactoferrin versus oral ferrous sulfate as an iron supplement for the treatment of IDA in children with IBD. We found that lactoferrin is a promising effective treatment with fewer side effects than oral elemental iron in children with IBD and IDA.
背景
缺铁性贫血（IDA）在炎症性肠病（IBD）患儿中很常见；然而，由于胃肠道副作用，口服铁补充剂通常与较差的依从性相关。我们比较了乳铁蛋白与口服硫酸亚铁治疗 IBD 患儿 IDA 的效果。
方法
纳入 92 例 IBD 合并 IDA 患儿，但仅有 80 例患儿完成了研究并被随机分为两组：硫酸亚铁组（n=40）接受硫酸亚铁 6mg/kg/天治疗 3 个月，乳铁蛋白组（n=40）接受乳铁蛋白 100mg/天治疗 3 个月。在治疗前后测量全血细胞计数、血清铁、总铁结合力（TIBC）、转铁蛋白饱和度（TS）、血清铁蛋白、白细胞介素-6（IL-6）和 25 型肝素。
结果
血红蛋白（Hb）、平均红细胞体积、血清铁、TS 和血清铁蛋白显著升高，而 TIBC 在给予硫酸亚铁或乳铁蛋白后与基线数据相比显著降低。此外，与硫酸亚铁相比，乳铁蛋白显著增加了 Hb、血清铁、TS 和血清铁蛋白。此外，乳铁蛋白显著降低了 IL-6 和肝素水平。
结论
乳铁蛋白是一种有前途的有效治疗方法，与口服元素铁相比，副作用更少，在 IBD 和 IDA 患儿中。
临床试验注册
该研究在 www.pactr.org（PACTR202002763901803）上注册。
影响
炎症性肠病（IBD）患儿的缺铁性贫血（IDA）用口服铁疗法治疗；然而，由于胃肠道副作用，口服铁补充剂通常与较差的依从性相关。据我们所知，我们的研究是儿科领域首次比较乳铁蛋白与口服硫酸亚铁作为 IBD 患儿 IDA 铁补充剂的疗效。我们发现，乳铁蛋白是一种有前途的有效治疗方法，与口服元素铁相比，副作用更少，在 IBD 和 IDA 患儿中。
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