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羟基氧化铁蔗糖与碳酸司维拉姆的疗效和安全性:一项系统评价与荟萃分析。

Efficacy and safety of sucroferric oxyhydroxide versus sevelamer carbonate: A systematic review and meta-analysis.

作者信息

Georgopoulos Christos, Duni Anila, Stamellou Eleni, Kitsos Athanasios, Gouva Charikleia, Dounousi Evangelia

机构信息

Department of Nephrology, University Hospital of Ioannina, Ioannina, Greece.

Department of Nephrology and Clinical Immunology, RWTH Aachen University Hospital, Aachen, Germany.

出版信息

Hemodial Int. 2025 Jan;29(1):6-16. doi: 10.1111/hdi.13187. Epub 2024 Oct 18.

Abstract

INTRODUCTION

Phosphate binders are commonly used in patients receiving kidney replacement therapy (KRT), aiming to reduce and maintain serum phosphorus. Chronic kidney disease-mineral and bone disorder has been linked to reduced lifespan and worsened quality of life. This study aims to examine the efficacy and safety of sucroferric oxyhydroxide versus sevelamer carbonate in patients receiving KRT.

METHODS

The data sources examined were MEDLINE (PubMed), Scopus, and the Cochrane Central Register of Controlled Clinical Trials with a search deadline of October 2023. We examined randomized controlled trials that compared sucroferric oxyhydroxide versus sevelamer carbonate in the adult population receiving KRT. We performed a meta-analysis combining the data from trials, using R-studio.

FINDINGS

Inclusion criteria were met by five randomized trials. There was no statistically significant difference in the reduction of serum phosphorus between the two groups (MD: -0.07 mmol/L, 95% CI-random effects: -0.15 to 0.02). In the same line, a non-statistically significant difference was observed in serum i-PTH reduction between the two drugs (MD = -1.53 mg/dL, 95% CI = (-4.45, 1.4), p = 0.26, random effects model). No statistically significant difference was observed in all adverse events between the two groups (odds ratio: 1.11, 95% CI: 0.65-1.88, random effects model). Further analysis of gastrointestinal adverse events revealed that sevelamer carbonate increases gastrointestinal adverse events by up to 60% (odds ratio: 1.60, 95% CI: 1.31-1.97, common (fixed) effect model).

DISCUSSION

This meta-analysis of randomized trials showed that both drugs, sucroferric oxyhydroxide and sevelamer equally and effectively controlled serum phosphorus levels, whereas sucroferric oxyhydroxide revealed a better profile in terms of gastrointestinal adverse events. Sucroferric oxyhydroxide is a valuable option for patients receiving KRT when sevelamer carbonate is more difficult to tolerate.

摘要

引言

磷结合剂常用于接受肾脏替代治疗(KRT)的患者,旨在降低并维持血清磷水平。慢性肾脏病-矿物质和骨异常与寿命缩短及生活质量恶化有关。本研究旨在探讨羟基氧化铁蔗糖与碳酸司维拉姆在接受KRT的患者中的疗效和安全性。

方法

所检索的数据源包括MEDLINE(PubMed)、Scopus以及截至2023年10月的Cochrane临床对照试验中心注册库。我们检索了比较羟基氧化铁蔗糖与碳酸司维拉姆在接受KRT的成年人群中的随机对照试验。我们使用R-studio对试验数据进行荟萃分析。

结果

五项随机试验符合纳入标准。两组在降低血清磷方面无统计学显著差异(MD:-0.07 mmol/L,95% CI-随机效应:-0.15至0.02)。同样,两种药物在降低血清i-PTH方面无统计学显著差异(MD = -1.53 mg/dL,95% CI =(-4.45,1.4),p = 0.26,随机效应模型)。两组在所有不良事件方面无统计学显著差异(优势比:1.11,95% CI:0.65 - 1.88,随机效应模型)。对胃肠道不良事件的进一步分析显示,碳酸司维拉姆使胃肠道不良事件增加多达60%(优势比:1.60,95% CI:1.31 - 1.97,共同(固定)效应模型)。

讨论

这项对随机试验的荟萃分析表明,羟基氧化铁蔗糖和碳酸司维拉姆这两种药物在控制血清磷水平方面同样有效,而羟基氧化铁蔗糖在胃肠道不良事件方面表现更佳。当碳酸司维拉姆更难以耐受时,羟基氧化铁蔗糖是接受KRT患者的一个有价值的选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c7c2/11730771/8ad05a9126f0/HDI-29-6-g005.jpg

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