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新型口服降钾药物-硅酸锆钠治疗高钾血症的疗效和安全性:系统评价和荟萃分析。

Effects and Safety of a Novel Oral Potassium-Lowering Drug-Sodium Zirconium Cyclosilicate for the Treatment of Hyperkalemia: a Systematic Review and Meta-Analysis.

机构信息

Department of Nephrology, Hunan Provincial Second People's Hospital, Hunan, China.

Department of Pharmacy, Xiji County People's Hospital, Ningxia, China.

出版信息

Cardiovasc Drugs Ther. 2021 Oct;35(5):1057-1066. doi: 10.1007/s10557-020-07134-2. Epub 2021 Jan 18.

DOI:10.1007/s10557-020-07134-2
PMID:33459923
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8452568/
Abstract

BACKGROUND

Oral sodium zirconium cyclosilicate (SZC) is a novel potassium binder capable of achieving a rapid reduction of serum potassium (sK) and maintaining a long-term normokalemia. We undertook a meta-analysis to summarize and evaluate the effects surrounding SZC in patients with hyperkalemia.

METHOD

We searched data sources from MEDLINE (from 1950 to Sep 2020), EMBASE (from 1970 to Sep 2020), and the Cochrane Library database (from 1950 to Sep 2020) for eligible studies. All randomized controlled trials (RCTs) regarding comparison of therapeutic effects of SZC in hyperkalemia participants were included.

RESULTS

Seven studies, including 1697 patients with hyperkalemia, were analyzed. SZC significantly reduced mean sK (-0.42 mmol/L; 95% CI: -0.63 to -0.20 mmol/L, p = 0.0001) compared with placebo, with a significantly greater proportion of patients with normokalemia (RR 3.48, 95% CI 1.49 to 8.11, p = 0.004). Subgroup analyses showed that the longer durations of SZC treatment, the greater magnitudes of potassium reduction when compared with those of placebo (p between subgroups = 0.01) at correction phase. Besides, it also demonstrated sK tended to decrease more in patients who got longer treatment or larger dosage of SZC at maintenance phase; however, the difference did not reach statistical significance. Additionally, the drug was equally effective in studies with larger than 50% of patients with chronic kidney disease (CKD) or diabetes or patients using renin-angiotensin aldosterone system inhibitor (RAAS) inhibitors (all p < 0.05). The risk of edema (4.30, 1.17 to 15.84; p = 0.03) in SZC group was higher than those of placebo group. No statistically significant differences in the risks of other adverse events were observed between the two groups.

CONCLUSIONS

SZC effectively decreased the sK level in patients with hyperkalemia within 48 h and had benefits in the long-term control of serum potassium in patients who continued to receive SZC with a favorable safety profile from available data.

摘要

背景

口服硅酸锆钠(SZC)是一种新型的钾结合剂,能够快速降低血清钾(sK)并维持长期血钾正常。我们进行了一项荟萃分析,以总结和评估 SZC 在高钾血症患者中的作用。

方法

我们从 MEDLINE(从 1950 年到 2020 年 9 月)、EMBASE(从 1970 年到 2020 年 9 月)和 Cochrane 图书馆数据库(从 1950 年到 2020 年 9 月)中搜索了符合条件的研究数据。纳入了比较 SZC 在高钾血症患者中治疗效果的所有随机对照试验(RCT)。

结果

共纳入了 7 项研究,包括 1697 例高钾血症患者。与安慰剂相比,SZC 显著降低了平均 sK(-0.42mmol/L;95%CI:-0.63 至 -0.20mmol/L,p=0.0001),且具有正常血钾的患者比例显著更高(RR 3.48,95%CI 1.49 至 8.11,p=0.004)。亚组分析显示,在校正阶段,SZC 治疗时间较长的患者,与安慰剂相比,钾降低的幅度更大(亚组间 p=0.01)。此外,在维持阶段,接受 SZC 治疗时间更长或剂量更大的患者,sK 也呈下降趋势,但差异无统计学意义。此外,该药物在接受肾素-血管紧张素-醛固酮系统抑制剂(RAAS)抑制剂治疗的患者或慢性肾脏病(CKD)或糖尿病患者比例大于 50%的研究中同样有效(所有 p<0.05)。SZC 组水肿的风险(4.30,1.17 至 15.84;p=0.03)高于安慰剂组。但两组间其他不良反应的风险无统计学差异。

结论

SZC 可在 48 小时内有效降低高钾血症患者的 sK 水平,并在继续接受 SZC 治疗的患者中具有长期控制血清钾的作用,且现有数据显示安全性良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4403/8452568/21c0cbaba835/10557_2020_7134_Fig7_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4403/8452568/21c0cbaba835/10557_2020_7134_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4403/8452568/f438b23a0dea/10557_2020_7134_Fig1_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4403/8452568/b18b13133240/10557_2020_7134_Fig5_HTML.jpg
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