口服苏糖酸铁羟化物长期治疗对透析患者铁及贫血标志物的影响

Chronic Therapy with Sucroferric Oxyhydroxide Does Not Affect Iron and Anemia Markers in Dialysis Patients.

机构信息

Department of Nephrology, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece,

Department of Nephrology, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece.

出版信息

Blood Purif. 2020;49(4):440-447. doi: 10.1159/000505432. Epub 2020 Feb 12.

DOI:10.1159/000505432

PMID:32050202

Abstract

INTRODUCTION

Sucroferric oxyhydroxide (SOH) is an iron-based phosphate binder (PB), and its use has been widely expanded since its initial approval in 2014. Based on the existing data, however, it remains yet unclear whether its long-term administration is followed by iron overload in dialysis patients. The purpose of this observational study was to evaluate the longstanding effects of SOH on the anemia and iron indices in patients on dialysis.

METHODS

A total of 110 patients from 3 dialysis centers were included in the study; 49 were under chronic treatment with SOH (cohort A), while 61 were either receiving other PB or no treatment for hyperphosphatemia (cohort B). We initially compared the hematologic profile of patients in 2 cohorts (phase I), and subsequently, we evaluated modifications of the above parameters in the SOH treated patients over a period of 6 months (phase II).

RESULTS

There were no statistically significant differences between 2 cohorts in terms of hemoglobin (Hb; 11.4 ± 1.3 vs. 11.6 ± 0.9 g/dL, p = 0.375), ferritin (473 ± 230 vs. 436 ± 235 ng/mL, p = 0.419) and transferrin saturation (TSAT;26.6 ± 13.2 vs. 26.5 ± 10.6%, p = 0.675), serum phosphate concentration (4.57 ± 1.05 vs. 4.3 ± 0.96 mg/dL, p = ns), and intact PTH (286 ± 313 vs. 239 ± 296 pg/mL, p = ns). Marginally, but significantly higher calcium levels were found in cohort A compared to cohort B (9.18 ± 0.58 vs. 8.9 ± 0.51 mg/dL, respectively, p = 0.008). In phase II, no significant changes were observed in hematological parameters after a 6-month treatment with SOH (Hb: from 11.5 ± 1.1 to 11.4 ± 1.3 g/dL, p = 0.4, serum ferritin levels: from 475 ± 264 to 473 ± 230 ng/mL, p = 0.951, TSAT: from 26.5 ± 16.7 to 26.6 ± 13.2%, p = 0.933). There were also no significant changes in the administration of iron supplements or erythropoietin dose during this period.

CONCLUSIONS

SOH is an effective PB, and its long-term use is not complicated by iron overload.

摘要

简介

蔗糖铁氧体（SOH）是一种铁基磷酸盐结合剂（PB），自 2014 年最初获得批准以来，其应用已得到广泛扩展。然而，根据现有数据，其在透析患者中的长期应用是否会导致铁过载仍不清楚。本观察性研究的目的是评估 SOH 对透析患者的贫血和铁指标的长期影响。

方法

共有 3 个透析中心的 110 名患者纳入本研究；49 名患者接受慢性 SOH 治疗（A 队列），而 61 名患者接受其他 PB 治疗或未治疗高磷血症（B 队列）。我们首先比较了 2 个队列的血液学特征（I 期），然后在 6 个月的时间内评估了 SOH 治疗患者的上述参数的变化（II 期）。

结果

2 个队列之间的血红蛋白（Hb；11.4 ± 1.3 与 11.6 ± 0.9 g/dL，p = 0.375）、铁蛋白（473 ± 230 与 436 ± 235 ng/mL，p = 0.419）和转铁蛋白饱和度（TSAT；26.6 ± 13.2 与 26.5 ± 10.6%，p = 0.675）、血清磷酸盐浓度（4.57 ± 1.05 与 4.3 ± 0.96 mg/dL，p = ns）和完整甲状旁腺激素（iPTH；286 ± 313 与 239 ± 296 pg/mL，p = ns）均无统计学差异。钙水平略有但显著升高，A 队列为 9.18 ± 0.58 mg/dL，B 队列为 8.9 ± 0.51 mg/dL（分别为 p = 0.008）。在 II 期，SOH 治疗 6 个月后，血液学参数无显著变化（Hb：从 11.5 ± 1.1 至 11.4 ± 1.3 g/dL，p = 0.4，血清铁蛋白水平：从 475 ± 264 至 473 ± 230 ng/mL，p = 0.951，TSAT：从 26.5 ± 16.7 至 26.6 ± 13.2%，p = 0.933）。在此期间，铁补充剂或促红细胞生成素剂量的使用也没有明显变化。