García-López Santiago, Bocos Judith Millastre, Gisbert Javier P, Bajador Eduardo, Chaparro María, Castaño Carlos, García-Erce José A, Gomollón Fernando
Department of Gastroenterology, University Hospital "Miguel Servet", Zaragoza, Spain.
Department of Gastroenterology, University Hospital "La Princesa", Institute of Health Investigation La Princesa (IP), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.
Blood Transfus. 2016 May;14(2):199-205. doi: 10.2450/2016.0246-15. Epub 2016 Apr 28.
Anaemia and iron deficiency are very common in inflammatory bowel disease. Clinical trials have shown intravenous iron to be effective and well tolerated. However, published experience in clinical practice with specific evaluation of the effect on quality of life is limited.
We carried out a prospective, multicentre, observational study on the effects of ferric carboxymaltose in the treatment of iron deficiency anaemia in inflammatory bowel disease. Anaemia and iron deficiency were defined according to World Health Organization criteria. Efficacy and safety were evaluated at infusion, at 2 weeks and at 12 weeks. Quality of life was evaluated according to the SIBDQ-9 index. Complete response was defined as anaemia correction or more tan 2 g/dL increase in haemoglobin.
A total of 88 courses of ferric carboxymaltose in 72 patients were evaluated. Complete response was observed in 46% of patients at week 2, and 81.2% at week 12. Quality of life improved significatively at week 2 in both complete responders and partial responders (p<0.0005); complete responders showed siginficantly better response (p=0.016). No predictive factor was identified. Only one transient adverse effect was observed; however, this was severe.
Ferric carboxymaltose showed comparable efficacy to that demonstrated in clinical trials. After only two weeks of treatment, there was a significant improvement in quality of life, with a greater effect observed in those patients with a complete haematologic response. Intravenous iron can very quickly improve quality of life in inflammatory bowel disease.
贫血和缺铁在炎症性肠病中非常常见。临床试验表明静脉铁剂有效且耐受性良好。然而,临床实践中关于其对生活质量影响的具体评估的已发表经验有限。
我们开展了一项前瞻性、多中心、观察性研究,以评估羧基麦芽糖铁治疗炎症性肠病缺铁性贫血的效果。贫血和缺铁根据世界卫生组织标准定义。在输注时、2周和12周时评估疗效和安全性。根据炎症性肠病问卷简表9(SIBDQ - 9)指数评估生活质量。完全缓解定义为贫血得到纠正或血红蛋白增加超过2g/dL。
共评估了72例患者的88个羧基麦芽糖铁疗程。2周时46%的患者观察到完全缓解,12周时为81.2%。完全缓解者和部分缓解者在第2周时生活质量均显著改善(p<0.0005);完全缓解者显示出显著更好的反应(p = 0.016)。未发现预测因素。仅观察到1例短暂的不良反应;然而,该反应严重。
羧基麦芽糖铁显示出与临床试验中相当的疗效。仅治疗两周后,生活质量就有显著改善,血液学完全缓解的患者效果更明显。静脉铁剂可非常迅速地改善炎症性肠病患者的生活质量。