Rostoker Guy, Vaziri Nosratola D
Division of Nephrology and Dialysis, Hôpital Privé Claude Galien, Ramsay-Générale de Santé, Quincy-sous-Sénart, France.
Division of Nephrology and Hypertension, University of California, Irvine, USA.
Heliyon. 2019 Jul 12;5(7):e02045. doi: 10.1016/j.heliyon.2019.e02045. eCollection 2019 Jul.
The routine use of recombinant erythropoiesis-stimulating agents (ESA) over the past three decades has enabled the partial correction of anaemia in most patients with end-stage renal disease (ESRD). Since ESA use frequently leads to iron deficiency, almost all ESA-treated haemodialysis patients worldwide receive intravenous iron (IV) to ensure sufficient available iron during ESA therapy. Patients with inflammatory bowel disease (IBD) are also often treated with IV iron preparations, as anaemia is common in IBD. Over the past few years, liver magnetic resonance imaging (MRI) has become the gold standard method for non-invasive diagnosis and follow-up of iron overload diseases. Studies using MRI to quantify liver iron concentration in ESRD have shown a link between high infused iron dose and risk of haemosiderosis in dialysis patients. In September 2017, the Pharmacovigilance Committee (PRAC) of the European Medicines Agency (EMA) considered convergent publications over the last few years on iatrogenic haemosiderosis in dialysis patients and requested that companies holding marketing authorization for iron products should investigate the risk of iron overload, particularly in patients with end-stage renal disease on dialysis and, by analogy, patients with IBD. We present a narrative review of data supporting the views and decision of the EMA, and then give our expert opinion on this controversial field of anaemia therapeutics.
在过去三十年中，重组促红细胞生成素（ESA）的常规使用已使大多数终末期肾病（ESRD）患者的贫血得到部分纠正。由于使用ESA经常导致缺铁，因此全球几乎所有接受ESA治疗的血液透析患者都接受静脉注射铁剂（IV），以确保在ESA治疗期间有足够的可用铁。炎症性肠病（IBD）患者也经常接受静脉注射铁剂治疗，因为贫血在IBD中很常见。在过去几年中，肝脏磁共振成像（MRI）已成为铁过载疾病无创诊断和随访的金标准方法。使用MRI对ESRD患者肝脏铁浓度进行量化的研究表明，高剂量静脉注射铁剂与透析患者的血色素沉着症风险之间存在关联。2017年9月，欧洲药品管理局（EMA）的药物警戒委员会（PRAC）审议了过去几年关于透析患者医源性血色素沉着症的趋同出版物，并要求持有铁产品上市许可的公司调查铁过载风险，特别是在接受透析的终末期肾病患者中，以及类推到IBD患者。我们对支持EMA观点和决定的数据进行了叙述性综述，然后就这一贫血治疗争议领域给出我们的专家意见。
