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聚苯乙烯磺酸钙和环硅酸锆钠作为血液透析患者慢性高钾血症钾结合剂的疗效和安全性:一项前瞻性研究。

Efficacy and safety of calcium polystyrene sulphonate and sodium zirconium cyclosilicate as potassium binders for chronic hyperkalemia in hemodialysis patients: A prospective study.

作者信息

Yu Feng, Rong Deng, Yongmei Yin, Di Pan, Jingru Yang

出版信息

Clin Nephrol. 2025 Jun;103(6):384-392. doi: 10.5414/CN111619.

Abstract

OBJECTIVE

Sodium zirconium cyclosilicate (SZC) and calcium polystyrene sulfonate (CPS) are indicated for treating hyperkalemia in chronic renal disease. Individuals undergoing maintenance hemodialysis (HD) are at significantly increased risk of developing hyperkalemia, clinically defined as serum potassium concentrations of > 5.0 mmol/L. The objective of this study was the evaluation and comparison of the efficacy and safety of two potassium binders (SZC and CPS) in HD patients with hyperkalemia.

MATERIALS AND METHODS

This research utilized a prospective non-randomized controlled clinical trial design. Patients with chronic hyperkalemia were enrolled at a tertiary care hospital in China from September 2021 to May 2022. HD patients received SZC (5 g) or CPS (5 g) once daily, later adjusted to 10 g. Serum potassium levels were quantified at a specified timepoint at 0, 2, 4, 8, and 12 weeks.

RESULTS

The mean serum K+ levels for SZC- and CPS-treated participants were 5.93 ± 0.46 and 5.88 ± 0.54 mmol/L, respectively, at baseline (p = 0.683) and 4.94 ± 0.44 vs. 5.12 ± 0.49 mmol/L respectively after 12 weeks (p = 0.017). A serum potassium concentration of less than 5.3 mmol/L was achieved in 81% of treated patients who received SZC treatment over 12 weeks, compared to 65% of those treated with CPS. Additionally, SZC also achieved a higher percentage of patients exhibiting serum potassium levels below 6.0 mmol/L at the 2-week timepoint (28/28 vs. 27/31, p = 0.015). The mean daily doses were 6.8 g for SZC and 7.42 g for CPS, with no serious adverse events attributable to the study drug.

CONCLUSION

SZC demonstrated superior effectiveness in reducing potassium levels and controlling severe hyperkalemia in patients undergoing maintenance HD. It also facilitated more rapid control of serum potassium levels offering an improved long-term management strategy for chronic hyperkalemia.

摘要

目的

环硅酸锆钠(SZC)和聚苯乙烯磺酸钙(CPS)适用于治疗慢性肾脏病中的高钾血症。接受维持性血液透析(HD)的个体发生高钾血症的风险显著增加,临床上将高钾血症定义为血清钾浓度>5.0 mmol/L。本研究的目的是评估和比较两种钾结合剂(SZC和CPS)在HD高钾血症患者中的疗效和安全性。

材料与方法

本研究采用前瞻性非随机对照临床试验设计。2021年9月至2022年5月,在中国一家三级医院招募慢性高钾血症患者。HD患者每天接受一次SZC(5 g)或CPS(5 g)治疗,随后调整至10 g。在第0、2、4、8和12周的指定时间点对血清钾水平进行定量。

结果

在基线时,接受SZC和CPS治疗的参与者的平均血清钾水平分别为5.93±0.46和5.88±0.54 mmol/L(p = 0.683),12周后分别为4.94±0.44和5.12±0.49 mmol/L(p = 0.017)。在接受SZC治疗12周的患者中,81%的患者血清钾浓度低于5.3 mmol/L,而接受CPS治疗的患者中这一比例为65%。此外,在2周时间点,SZC组血清钾水平低于6.0 mmol/L的患者百分比也更高(28/28 vs. 27/31,p = 0.015)。SZC的平均日剂量为6.8 g,CPS为7.42 g,未出现与研究药物相关的严重不良事件。

结论

SZC在降低维持性HD患者的血钾水平和控制严重高钾血症方面显示出卓越疗效。它还能更快地控制血清钾水平,为慢性高钾血症提供了更好的长期管理策略。

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