Portolés-Pérez Jose, Durá-Gúrpide Beatriz, Merino-Rivas José Luis, Martín-Rodriguez Leyre, Hevia-Ojanguren Covadonga, Burguera-Vion Victor, Yuste-Lozano Claudia, Sánchez-García Luisa, Rodriguez-Palomares Jose Ramon, Paraiso Vicente
Nephrology Department, University Hospital Puerta de Hierro, Madrid, Spain.
RedInRen ISCiii 016/009 Public Research Net, Madrid, Spain.
Clin Kidney J. 2019 Nov 22;14(1):174-180. doi: 10.1093/ckj/sfz153. eCollection 2021 Jan.
The efficacy of intravenous (IV) ferric carboxymaltose (FCM) has been demonstrated in haemodialysis and non-dialysis studies, but evidence is lacking in patients undergoing peritoneal dialysis (PD).
This multicentre, retrospective study evaluated the effectiveness and safety of FCM in patients on PD over 12 months. We retrospectively reviewed the electronic medical records of PD patients who initiated FCM treatment between 2014 and 2017 across seven Spanish centres.
Ninety-one patients were included in the safety population (mean ± SD age 57.7 ± 15.0 years) and 70 in the efficacy population (mean age 50.9 ± 14.5 years). No hypersensitivity reaction, FCM discontinuation or dose adjustment due to a serious adverse event (SAE) was registered in the safety population. The most common non-SAEs reported were headache (four events), mild hypotension (three events) and hypertension (two events), among others. In the efficacy population ( = 70), 68.6% of patients achieved ferritin levels of 200-800 ng/mL, 78.4% achieved transferrin saturation (TSAT) >20%, and 62.8% achieved TSAT >20% and ferritin >200 ng/mL after 12 months of FCM initiation (P<0.01). Haemoglobin (Hb) levels were maintained at >11 g/dL with a lower dose of darbepoetin throughout the follow-up. The sub-analysis of patients naïve to IV iron and with absolute or relative iron deficiency ( = 51) showed that 76.5% reached ferritin >200 ng/mL, 80.4% TSAT >20% and Hb increased (1.2 g/dL) after 4 months of FCM treatment (P<0.01).
In this multicentre, retrospective, real-world study conducted in the PD population, FCM was effective, safe and easy to administer during routine clinical visits.
静脉注射羧麦芽糖铁（FCM）的疗效已在血液透析和非透析研究中得到证实，但腹膜透析（PD）患者缺乏相关证据。
这项多中心回顾性研究评估了FCM在PD患者中12个月的有效性和安全性。我们回顾性分析了2014年至2017年期间西班牙七个中心开始FCM治疗的PD患者的电子病历。
91例患者纳入安全性人群（平均年龄±标准差57.7±15.0岁），70例纳入有效性人群（平均年龄50.9±14.5岁）。安全性人群中未记录到因严重不良事件（SAE）导致的过敏反应、FCM停药或剂量调整。报告的最常见非SAE包括头痛（4例）、轻度低血压（3例）和高血压（2例）等。在有效性人群（n = 70）中，68.6%的患者在开始FCM治疗12个月后铁蛋白水平达到200 - 800 ng/mL，78.4%的患者转铁蛋白饱和度（TSAT）>20%，62.8%的患者TSAT>20%且铁蛋白>200 ng/mL（P<0.01）。在整个随访期间，较低剂量的促红细胞生成素可使血红蛋白（Hb）水平维持在>11 g/dL。对初次接受静脉铁剂治疗且存在绝对或相对缺铁的患者（n = 51）进行亚组分析显示，FCM治疗4个月后，76.5%的患者铁蛋白>200 ng/mL，80.4%的患者TSAT>20%且Hb升高（1.2 g/dL）（P<0.01）。
在这项针对PD人群的多中心回顾性真实世界研究中，FCM在常规临床访视期间有效、安全且易于给药。
