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单次剂量的硅酸锆钠与聚苯乙烯磺酸纳在住院高钾血症患者中的疗效比较。

Single Dose of Sodium Zirconium Cyclosilicate Versus Sodium Polystyrene Sulfonate in Hospitalized Patients With Hyperkalemia.

机构信息

JFK University Medical Center, Hackensack Meridian Health, Edison, NJ, USA.

出版信息

Ann Pharmacother. 2023 Sep;57(9):1044-1052. doi: 10.1177/10600280221141918. Epub 2023 Jan 13.

Abstract

BACKGROUND

Sodium zirconium cyclosilicate (SZC) is an inorganic zirconium silicate compound that selectively exchanges potassium for hydrogen and sodium. "Once" doses of SZC (with option to redose) in patients with hyperkalemia in hospitalized settings have not been evaluated. We hypothesized that a once dose of SZC would be non-inferior to sodium polystyrene sulfonate (SPS) in reducing serum potassium.

OBJECTIVE

The objective of our study is to evaluate the effect of a "once" dose of SZC when compared with SPS in reducing serum potassium levels.

METHODS

This was a retrospective analysis of patients who received either a "once" dose of SZC or single or repeated doses of SPS for hyperkalemia. The primary endpoint was mean absolute reduction in the first serum potassium value at least 4 hours after administration. The secondary efficacy endpoints were the rate of additional potassium-lowering therapies and the rate of normokalemia within 48 hours. Safety endpoints were the incidence of electrolyte abnormalities, hypoglycemia, hypertension, hypotension, and colonic necrosis.

RESULTS

A total of 260 patients were included in the analysis. The mean initial serum potassium was similar between groups (5.6 ± 0.4). The absolute serum potassium reduction was -0.88 ± 0.64 mEq/L and -0.75 ± 0.65 mEq/L with SZC and SPS, respectively. The "once" regimen of SZC demonstrated non-inferiority compared with SPS ( < 0.0001). The proportion of patients achieving normokalemia within 48 hours and the proportion of patients receiving additional potassium-lowering therapies did not differ between groups.

CONCLUSION AND RELEVANCE

The "once" dose regimen (with redose option) of SZC was non-inferior to the "once" or repeated dosing regimen of SPS with regard to absolute potassium reduction. There were no significant differences in the rate of additional potassium-lowering therapies and the rate of normokalemia at 48 hours. The incidence of hypertension was less common among patients who received SZC.

摘要

背景

硅酸锆酸钠(SZC)是一种无机硅锆化合物,可选择性地将钾交换为氢和钠。尚未评估过在住院环境中患有高钾血症的患者中使用 SZC 的“一次”剂量(可选择再次给药)。我们假设 SZC 的一次剂量在降低血清钾方面不亚于聚苯乙烯磺酸(SPS)。

目的

本研究的目的是评估与 SPS 相比,SZC 的“一次”剂量在降低血清钾水平方面的效果。

方法

这是一项回顾性分析,纳入了接受 SZC 的“一次”剂量或 SPS 的单次或多次剂量治疗高钾血症的患者。主要终点是给药后至少 4 小时第一次血清钾值的平均绝对降低。次要疗效终点是额外降低血钾治疗的比率和 48 小时内正常血钾的比率。安全性终点是电解质异常、低血糖、高血压、低血压和结肠坏死的发生率。

结果

共纳入 260 例患者进行分析。两组的平均初始血清钾相似(5.6±0.4)。SZC 和 SPS 的绝对血清钾降低分别为-0.88±0.64mEq/L 和-0.75±0.65mEq/L。与 SPS 相比,SZC 的“一次”方案显示出非劣效性(<0.0001)。48 小时内达到正常血钾的患者比例和需要额外降低血钾治疗的患者比例在两组之间没有差异。

结论和相关性

SZC 的“一次”剂量方案(可选择再次给药)在绝对血钾降低方面与 SPS 的“一次”或重复剂量方案不劣效。在额外降低血钾治疗的比率和 48 小时内达到正常血钾的比率方面没有显著差异。接受 SZC 的患者中高血压的发生率较低。

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