非透析依赖型慢性肾脏病或腹膜透析患者中麦芽糖铁复合物的评估

Ferric Derisomaltose Evaluation in Patients with Non-Dialysis-Dependent Chronic Kidney Disease or Peritoneal Dialysis.

作者信息

England Emma, Sheffield Maneka, Poyah Penelope, Clark David, Wilson Jo-Anne

机构信息

, BScPharm, was, at the time of this study, a student with the College of Pharmacy, Faculty of Health, Dalhousie University, Halifax, Nova Scotia. She is now a Pharmacy Resident with the Kingston Health Sciences Centre, Kingston, Ontario, and is a candidate for the ACPR credential.

, BScPharm, is a Clinical Pharmacist with the Renal Program of Nova Scotia Health, Halifax, Nova Scotia.

出版信息

Can J Hosp Pharm. 2023 Mar 1;76(2):94-101. doi: 10.4212/cjhp.3310. eCollection 2023 Spring.

DOI:10.4212/cjhp.3310

PMID:36998753

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10049766/

Abstract

BACKGROUND

Iron deficiency anemia is common in patients with advanced chronic kidney disease (CKD). Ferric derisomaltose (FDI) enables iron repletion in a single dose, unlike other forms of iron for IV administration, which require multiple doses. Protocols are commonly used with other IV irons, but there are limited Canadian data for FDI, and no protocol exists.

OBJECTIVES

To evaluate the efficacy and safety of FDI for patients with CKD and to ascertain information related to its use in Canadian provinces.

METHODS

This retrospective cohort study involved patients with non-dialysis-dependent CKD (NDD-CKD) and patients undergoing peritoneal dialysis (PD) who received FDI in a tertiary hospital in Nova Scotia between June 2020 and May 2021. Each patient was followed for a minimum of 6 months. The efficacy outcomes were the changes from baseline in hemoglobin, transferrin saturation (TSAT), and ferritin after the first dose of FDI and at 3 and 6 months. The safety outcomes were the frequency and types of adverse reactions to FDI. Electronic surveys were sent to 33 Canadian renal pharmacists to gather information about FDI use, dosing, administration, monitoring, funding, and safety in their respective organizations.

RESULTS

A total of 52 infusions were administered to 35 patients during the study period. The median times between doses 1 and 2 and between doses 2 and 3 were 19.1 and 6.6 weeks, respectively. The median change from baseline to first post-FDI follow-up blood work was significant for hemoglobin (9.0 g/L, = 0.023), TSAT (11 percentage points, < 0.001), and ferritin (271.4 μg/L, < 0.001). Median darbepoetin doses decreased from baseline to 6 months ( < 0.001). Three adverse reactions occurred. At least 15 (65%) of the 23 survey respondents reported that FDI was funded by their province or was listed on their hospital drug formulary.

CONCLUSION

This study provides evidence that FDI is an effective and safe treatment for anemia in NDD-CKD and PD patients.

摘要

背景

缺铁性贫血在晚期慢性肾脏病（CKD）患者中很常见。与其他需要多次给药的静脉注射铁剂不同，去铁胺麦芽糖铁（FDI）单剂量即可补充铁。其他静脉铁剂通常使用方案，但加拿大关于FDI的数据有限，且尚无相关方案。

目的

评估FDI对CKD患者的疗效和安全性，并确定其在加拿大各省使用的相关信息。

方法

这项回顾性队列研究纳入了2020年6月至2021年5月在新斯科舍省一家三级医院接受FDI的非透析依赖型CKD（NDD-CKD）患者和接受腹膜透析（PD）的患者。每位患者至少随访6个月。疗效指标为首次FDI给药后以及3个月和6个月时血红蛋白、转铁蛋白饱和度（TSAT）和铁蛋白相对于基线的变化。安全性指标为对FDI不良反应的频率和类型。向33名加拿大肾脏药剂师发送了电子调查问卷，以收集有关其各自机构中FDI使用、剂量、给药、监测、资金和安全性的信息。

结果

在研究期间，共对35名患者进行了52次输注。第1剂和第2剂之间以及第2剂和第3剂之间的中位时间分别为19.1周和6.6周。从基线到首次FDI后随访血液检查，血红蛋白（9.0 g/L，P = 0.023）、TSAT（11个百分点，P < 0.001）和铁蛋白（271.4 μg/L，P < 0.001）的中位变化具有显著性。从基线到6个月，促红细胞生成素的中位剂量下降（P < 0.001）。发生了3例不良反应。23名调查受访者中至少有15名（65%）报告称FDI由其所在省份资助或列在其医院药品处方集上。