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蔗糖铁氧羟化物治疗慢性肾脏病高磷血症的疗效和安全性。FOSFASTUR 研究。

Efficacy and safety of sucroferric oxyhydroxide in the treatment of hyperphosphataemia in chronic kidney disease. FOSFASTUR study.

机构信息

Servicio de Nefrología, Hospital Universitario de Cabueñes, Gijón, Asturias, España.

Servicio de Otorrinolaringología, Hospital Universitario Central de Asturias, Oviedo, Asturias, España.

出版信息

Nefrologia (Engl Ed). 2021 Jan-Feb;41(1):45-52. doi: 10.1016/j.nefro.2020.06.008. Epub 2020 Nov 22.

DOI:10.1016/j.nefro.2020.06.008
PMID:33239181
Abstract

INTRODUCTION

Alterations in bone and mineral metabolism are very common in chronic kidney disease (CKD). The increase in phosphate levels leads to bone disease, risk of calcification and greater mortality, so any strategy aimed at reducing them should be welcomed. The latest drug incorporated into the therapeutic arsenal to treat hyperphosphataemia in CKD is sucroferric oxyhydroxide (SFO).

OBJECTIVE

To analyse the efficacy and safety of SFO in 3 cohorts of patients, one with advanced CKD not on dialysis, another on peritoneal dialysis and the last on haemodialysis, followed for 6 months.

METHODS

A prospective, observational, multicentre study in clinical practice. Clinical and epidemiological variables were analysed. The evolution of parameters relating to alterations in bone and mineral metabolism and anaemia was analysed.

RESULTS

Eighty-five patients were included in the study (62±12 years, 64% male, 34% diabetic), 25 with advanced CKD not on dialysis, 25 on peritoneal dialysis and lastly, 35 on haemodialysis. In 66 patients (78%), SFO was the first phosphate binder; in the other 19, SFO replaced a previous phosphate binder due to poor tolerance or efficacy. The initial dose of SFO was 964±323mg/day. Overall, serum phosphate levels saw a significant reduction at 3 months of treatment (19.6%; P<.001). There were no differences in the efficacy of the drug when the different populations analysed were compared. Over the course of the study, there were no changes to levels of calcium, PTHi, ferritin, transferrin saturation index or haemoglobin, although there was a tendency for the last 2 to increase. Twelve patients (14%) withdrew from follow-up, 10 due to gastrointestinal adverse effects (primarily diarrhoea) and 2 were lost to follow-up (kidney transplant). The mean dose of the drug that the patients received increased over time, up to 1,147±371mg/day.

CONCLUSIONS

SFO is an effective option for the treatment of hyperphosphataemia in patients with CKD both in the advanced phases of the disease and on dialysis. We found similar efficacy across the 3 groups analysed. The higher their baseline phosphate level, the greater the reduction in the serum levels. A notable reduction in phosphate levels can be achieved with doses of around 1,000mg/day. Diarrhoea was the most common side effect, although it generally was not significant.

摘要

简介

慢性肾脏病(CKD)患者的骨骼和矿物质代谢会发生严重改变。血磷酸盐水平升高会导致骨骼疾病、钙化风险和更高的死亡率,因此任何旨在降低磷酸盐水平的策略都应该受到欢迎。最新加入 CKD 治疗高磷酸盐血症药物是蔗糖铁氧羟化物(SFO)。

目的

分析 SFO 在 3 组患者中的疗效和安全性,一组为未进行透析的晚期 CKD 患者,另一组为腹膜透析患者,最后一组为血液透析患者,随访 6 个月。

方法

这是一项在临床实践中进行的前瞻性、观察性、多中心研究。分析了临床和流行病学变量。分析了与骨骼和矿物质代谢及贫血改变相关的参数变化。

结果

研究纳入了 85 名患者(62±12 岁,64%为男性,34%为糖尿病患者),其中 25 名未进行透析的晚期 CKD 患者,25 名腹膜透析患者,最后 35 名血液透析患者。在 66 名患者(78%)中,SFO 是第一种磷酸盐结合剂;在其余 19 名患者中,由于耐受性或疗效不佳,SFO 替代了之前的磷酸盐结合剂。SFO 的初始剂量为 964±323mg/天。总体而言,治疗 3 个月后血清磷酸盐水平显著降低(19.6%;P<.001)。比较分析的不同人群之间,药物疗效无差异。在研究过程中,钙、iPTH、铁蛋白、转铁蛋白饱和度指数或血红蛋白水平没有变化,尽管最后两项有升高趋势。12 名患者(14%)退出随访,10 名因胃肠道不良反应(主要为腹泻),2 名失访(肾移植)。患者接受药物的平均剂量随时间推移而增加,最高可达 1147±371mg/天。

结论

SFO 是治疗 CKD 患者高磷酸盐血症的有效选择,无论是在疾病晚期还是透析患者中。我们发现 3 组分析的疗效相似。基线磷酸盐水平越高,血清水平降低幅度越大。每天约 1000mg 的剂量即可显著降低磷酸盐水平。腹泻是最常见的副作用,但通常不严重。

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