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透析患者新旧钾结合剂的疗效差异:系统评价与荟萃分析

Differences in Efficacy Among New and Old Potassium Binders in Dialysis Patients: A Systematic Review and Meta-Analysis.

作者信息

Zirino Fortunata, Maressa Veronica, Messina Roberta Maria, Stancanelli Maria Rita, Gembillo Guido, Longhitano Elisa, Taverna Giovanni, Geraci Giulio, Cernaro Valeria, Santoro Domenico, Calabrese Vincenzo

机构信息

Unit of Nephrology and Dialysis, P.O. Maggiore "Nino Baglieri", Modica (RG), Italy.

Unit of Nephrology and Dialysis, Department of clinical and experimental medicine, University Hospital "G. Martino", Messina, 98100, Italy.

出版信息

G Ital Nefrol. 2025 Aug 29;42(4):2025-vol4. doi: 10.69097/42-04-2025-06.

Abstract

Hyperkalemia is a common and serious complication in dialysis patients, with increased incidence and severity over time. Newer potassium binders, patiromer and sodium zirconium cyclosilicate (SZC), offer improved tolerability compared to older agents. This meta-analysis aims to evaluate the efficacy and safety of these newer binders in dialysis patients. This systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted, adhering to PRISMA guidelines. Searches were performed in MEDLINE, PubMed, CINAHL, and EMBASE up to November 1, 2024. RCTs comparing patiromer or SZC to placebo, sodium polystyrene sulfonate (SPS), or calcium polystyrene sulfonate (CPS) in dialysis patients were included. Primary outcomes were differences in serum potassium levels. Secondary outcomes included adverse events (AEs) and mortality. Data were analyzed using fixed and random-effects models, and heterogeneity was assessed. Six RCTs, involving 3155 patients, were included. SZC and SPS significantly reduced pre-HD potassium levels compared to placebo (mean difference -0.68 mmol/L and -0.62 mmol/L, respectively; p<0.0001). Patiromer did not show a significant difference compared to placebo (mean difference -0.17 mmol/L; p=0.16). All treatments demonstrated a reduction in hyperkalemia events compared to placebo. Adverse event data were limited and not statistically analyzable, but no significant differences in total AEs were observed. Mortality data were sparse, with only one death reported in the placebo group. High heterogeneity was observed in the comparison between new and old binders/placebo. SZC and SPS effectively reduce pre-HD potassium levels in dialysis patients compared to placebo. Patiromer's effect was not statistically significant. All binders reduced hyperkalemia events. Safety profiles appeared comparable, but data were limited. The lack of sufficient RCTs, especially those directly comparing newer binders, highlights a significant knowledge gap. Further studies are needed to evaluate long-term outcomes, including quality of life and cardiovascular effects, and to directly compare the efficacy and safety of different potassium binders in this population.

摘要

高钾血症是透析患者常见且严重的并发症,其发病率和严重程度会随时间增加。与传统药物相比,新型钾结合剂帕替罗姆和环硅酸锆钠(SZC)的耐受性有所提高。本荟萃分析旨在评估这些新型结合剂在透析患者中的疗效和安全性。本研究按照PRISMA指南,对随机对照试验(RCT)进行了系统评价和荟萃分析。截至2024年11月1日,在MEDLINE、PubMed、CINAHL和EMBASE中进行了检索。纳入了在透析患者中将帕替罗姆或SZC与安慰剂、聚苯乙烯磺酸钠(SPS)或聚苯乙烯磺酸钙(CPS)进行比较的RCT。主要结局是血清钾水平的差异。次要结局包括不良事件(AE)和死亡率。使用固定效应模型和随机效应模型对数据进行分析,并评估异质性。纳入了6项RCT,涉及3155名患者。与安慰剂相比,SZC和SPS显著降低了透析前钾水平(平均差异分别为-0.68 mmol/L和-0.62 mmol/L;p<0.0001)。与安慰剂相比,帕替罗姆未显示出显著差异(平均差异-0.17 mmol/L;p=0.16)。与安慰剂相比,所有治疗均显示高钾血症事件减少。不良事件数据有限且无法进行统计学分析,但未观察到总不良事件有显著差异。死亡率数据稀少,安慰剂组仅报告1例死亡。在新型与传统结合剂/安慰剂的比较中观察到高度异质性。与安慰剂相比,SZC和SPS可有效降低透析患者透析前的钾水平。帕替罗姆的效果无统计学意义。所有结合剂均减少了高钾血症事件。安全性概况似乎相当,但数据有限。缺乏足够的RCT,尤其是那些直接比较新型结合剂的研究,凸显了显著的知识空白。需要进一步研究来评估长期结局,包括生活质量和心血管影响,并直接比较不同钾结合剂在该人群中的疗效和安全性。

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