• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

硅酸锆钠:高钾血症治疗中的研究进展。

Sodium Zirconium Cyclosilicate: A Review in Hyperkalaemia.

机构信息

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Drugs. 2018 Oct;78(15):1605-1613. doi: 10.1007/s40265-018-0991-6.

DOI:10.1007/s40265-018-0991-6
PMID:30306338
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6433811/
Abstract

Sodium zirconium cyclosilicate (Lokelma™) [hereafter referred to as SZC] is a non-absorbed, non-polymer zirconium silicate compound that preferentially exchanges hydrogen and sodium for potassium and ammonium ions in the gastrointestinal tract (GIT), thereby increasing faecal potassium excretion and lowering serum potassium levels. It is available as a powder for oral suspension (in water) and is approved in the EU and the USA for the treatment of hyperkalaemia in adults. In two multinational, phase III studies in adults with hyperkalaemia, SZC 10 g three times daily lowered serum potassium levels to within the normal range (3.5-5.0 mmol/L) during the first 48 h of treatment, and SZC 5 and 10 g once daily maintained normokalaemia over ≤ 28 days' therapy. These beneficial effects were consistent across all patient subgroups (e.g. chronic kidney disease, diabetes, heart failure, concomitant use of RAAS inhibitor therapy), and appeared to be maintained over the longer term (≤ 12 months). SZC was generally well tolerated in adults with hyperkalaemia. Its tolerability profile was generally similar to that seen with placebo over ≤ 28 day, and its safety profile appeared to remain consistent over the longer term (≤ 12 months). Moreover, the incidence of hypokalemia was low. Current evidence indicates that SZC is a promising therapy for the management of hyperkalaemia in adults.

摘要

硅酸锆酸钠(Lokelma™)[以下简称 SZC]是一种不被吸收的非聚合硅酸锆化合物,它在胃肠道(GI)中优先将氢和钠与钾和铵离子交换,从而增加粪便中钾的排泄并降低血清钾水平。它以粉末形式用于口服混悬液(在水中),在欧盟和美国被批准用于治疗成人高钾血症。在两项针对成人高钾血症的多中心 III 期研究中,SZC 每日三次 10g 可在治疗的前 48 小时内将血清钾水平降低至正常范围(3.5-5.0mmol/L),而每日一次 5g 和 10g 可维持≤28 天的正常血钾水平。这些有益的效果在所有患者亚组中都是一致的(例如,慢性肾脏病、糖尿病、心力衰竭、同时使用 RAAS 抑制剂治疗),并且似乎在较长时间内(≤12 个月)保持稳定。SZC 在成人高钾血症中通常具有良好的耐受性。其耐受性与安慰剂在≤28 天内的情况相似,其安全性在较长时间内(≤12 个月)似乎保持一致。此外,低钾血症的发生率较低。目前的证据表明,SZC 是治疗成人高钾血症的一种很有前途的治疗方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b69/6433811/89a1945b14f7/40265_2018_991_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b69/6433811/89a1945b14f7/40265_2018_991_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b69/6433811/89a1945b14f7/40265_2018_991_Fig1_HTML.jpg

相似文献

1
Sodium Zirconium Cyclosilicate: A Review in Hyperkalaemia.硅酸锆钠:高钾血症治疗中的研究进展。
Drugs. 2018 Oct;78(15):1605-1613. doi: 10.1007/s40265-018-0991-6.
2
Effects and Safety of a Novel Oral Potassium-Lowering Drug-Sodium Zirconium Cyclosilicate for the Treatment of Hyperkalemia: a Systematic Review and Meta-Analysis.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。
Cardiovasc Drugs Ther. 2021 Oct;35(5):1057-1066. doi: 10.1007/s10557-020-07134-2. Epub 2021 Jan 18.
3
Long-term safety and efficacy of sodium zirconium cyclosilicate for hyperkalaemia in patients with mild/moderate versus severe/end-stage chronic kidney disease: comparative results from an open-label, Phase 3 study.环硅酸锆钠治疗轻/中度与严重/终末期慢性肾脏病高钾血症患者的长期安全性和疗效:一项开放标签、3 期研究的比较结果。
Nephrol Dial Transplant. 2021 Jan 1;36(1):137-150. doi: 10.1093/ndt/gfz285.
4
Sodium zirconium cyclosilicate increases serum bicarbonate concentrations among patients with hyperkalaemia: exploratory analyses from three randomized, multi-dose, placebo-controlled trials.硅酸锆酸钠可升高高钾血症患者的血清碳酸氢盐浓度:三项随机、多剂量、安慰剂对照试验的探索性分析。
Nephrol Dial Transplant. 2021 Apr 26;36(5):871-883. doi: 10.1093/ndt/gfaa158.
5
HARMONIZE Asia: A Phase III Randomized Study to Investigate the Efficacy and Safety of Sodium Zirconium Cyclosilicate in Patients with Hyperkalemia in China.HARMONIZE Asia:一项在中国进行的评估钠锆石环硅酸治疗高钾血症有效性和安全性的 III 期随机研究
Clin Ther. 2024 Sep;46(9):702-710. doi: 10.1016/j.clinthera.2024.07.004. Epub 2024 Aug 6.
6
Efficacy and safety of sodium zirconium cyclosilicate for hyperkalaemia: the randomized, placebo-controlled HARMONIZE-Global study.环硅酸锆钠治疗高钾血症的疗效和安全性:一项随机、安慰剂对照的 HARMONIZE-Global 研究。
ESC Heart Fail. 2020 Feb;7(1):54-64. doi: 10.1002/ehf2.12561. Epub 2020 Jan 15.
7
Correction of serum potassium with sodium zirconium cyclosilicate in Japanese patients with hyperkalemia: a randomized, dose-response, phase 2/3 study.日本高钾血症患者用硅酸锆钠纠正血清钾:一项随机、剂量反应、2/3 期研究。
Clin Exp Nephrol. 2020 Dec;24(12):1144-1153. doi: 10.1007/s10157-020-01937-1. Epub 2020 Aug 10.
8
A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study of Sodium Zirconium Cyclosilicate for Reducing the Incidence of Predialysis Hyperkalemia.一项评估钠锆石环硅酸钠减少透析前高钾血症发生率的 3b 期、随机、双盲、安慰剂对照研究。
J Am Soc Nephrol. 2019 Sep;30(9):1723-1733. doi: 10.1681/ASN.2019050450. Epub 2019 Jun 14.
9
An evaluation of sodium zirconium cyclosilicate as a treatment option for hyperkalemia.评估环硅酸锆钠作为高钾血症治疗选择的价值。
Expert Opin Pharmacother. 2021 Jan;22(1):19-28. doi: 10.1080/14656566.2020.1810234. Epub 2020 Sep 7.
10
An evaluation of sodium zirconium cyclosilicate: a new treatment option for hyperkalaemia in China.评估硅酸锆酸钠:一种中国高钾血症的新治疗选择。
Expert Opin Pharmacother. 2023 Feb;24(3):301-308. doi: 10.1080/14656566.2022.2161884. Epub 2023 Jan 8.

引用本文的文献

1
Adverse drug events associated with sodium zirconium cyclosilicate: A real-world pharmacovigilance study based on the FAERS database.与环硅酸锆钠相关的药物不良事件:一项基于FAERS数据库的真实世界药物警戒研究。
PLoS One. 2025 Sep 2;20(9):e0330340. doi: 10.1371/journal.pone.0330340. eCollection 2025.
2
Sodium Zirconium Cyclosilicate in the Gastrointestinal Tract Mimicking an Acute Gastrointestinal Bleed on CT.胃肠道中的环硅酸锆钠在CT上模拟急性胃肠道出血
Reports (MDPI). 2025 Apr 10;8(2):45. doi: 10.3390/reports8020045.
3
Prevalence, practice pattern, and mortality of hyperkalemia in Chinese patients undergoing hemodialysis in the visualize HD study.

本文引用的文献

1
Long-term safety and efficacy of sodium zirconium cyclosilicate for hyperkalaemia in patients with mild/moderate versus severe/end-stage chronic kidney disease: comparative results from an open-label, Phase 3 study.环硅酸锆钠治疗轻/中度与严重/终末期慢性肾脏病高钾血症患者的长期安全性和疗效:一项开放标签、3 期研究的比较结果。
Nephrol Dial Transplant. 2021 Jan 1;36(1):137-150. doi: 10.1093/ndt/gfz285.
2
Controversies in Management of Hyperkalemia.高钾血症管理中的争议
J Emerg Med. 2018 Aug;55(2):192-205. doi: 10.1016/j.jemermed.2018.04.004. Epub 2018 May 3.
3
New Therapeutic Approaches for the Treatment of Hyperkalemia in Patients Treated with Renin-Angiotensin-Aldosterone System Inhibitors.
可视化血液透析研究中接受血液透析的中国患者高钾血症的患病率、治疗模式及死亡率
Sci Rep. 2025 Jul 1;15(1):22405. doi: 10.1038/s41598-025-92609-1.
4
Calcium Ion Sensors with Unrivaled Stability and Selectivity Using a Bilayer Approach with Ionically Imprinted Nanocomposites.采用离子印迹纳米复合材料双层方法的具有无与伦比稳定性和选择性的钙离子传感器。
Nanomaterials (Basel). 2025 May 15;15(10):741. doi: 10.3390/nano15100741.
5
Prognostic Impact of Long-Term Sodium Zirconium Cyclosilicate-Integrated Medical Therapy in Patients with Systolic Heart Failure.长期使用环硅酸钠锆钠联合药物治疗对收缩性心力衰竭患者的预后影响
J Clin Med. 2025 Apr 20;14(8):2836. doi: 10.3390/jcm14082836.
6
Safety assessment of sodium zirconium cyclosilicate: A FAERS-based disproportionality analysis.环硅酸锆钠的安全性评估:基于美国食品药品监督管理局不良事件报告系统的不成比例性分析
PLoS One. 2025 Mar 25;20(3):e0320585. doi: 10.1371/journal.pone.0320585. eCollection 2025.
7
A Case of Sigmoid Colon Perforation Associated with Sodium Zirconium Cyclosilicate in a Patient with Advanced Rectal Cancer.晚期直肠癌患者中一例与环硅酸锆钠相关的乙状结肠穿孔病例
Surg Case Rep. 2025;11(1). doi: 10.70352/scrj.cr.24-0123. Epub 2025 Mar 11.
8
Effect of sodium zirconium cyclosilicate on hyperkalemia after parathyroidectomy in secondary hyperparathyroidism patients with maintenance hemodialysis: A randomized trial.环硅酸锆钠对维持性血液透析的继发性甲状旁腺功能亢进患者甲状旁腺切除术后高钾血症的影响:一项随机试验。
Medicine (Baltimore). 2024 Dec 27;103(52):e40917. doi: 10.1097/MD.0000000000040917.
9
Effect of Gastric pH on the Pharmacokinetics of Atorvastatin and its Metabolites in Healthy Participants.胃内pH值对健康受试者中阿托伐他汀及其代谢产物药代动力学的影响。
Eur J Drug Metab Pharmacokinet. 2025 Mar;50(2):175-186. doi: 10.1007/s13318-025-00937-4. Epub 2025 Feb 16.
10
Rescue RM/CS-AKI by blocking strategy with one-dose anti-myoglobin RabMAb.通过单剂量抗肌红蛋白兔单克隆抗体阻断策略挽救肾损伤分子-1/胱抑素C急性肾损伤
Nat Commun. 2025 Jan 26;16(1):1044. doi: 10.1038/s41467-025-56353-4.
治疗肾素-血管紧张素-醛固酮系统抑制剂治疗患者高钾血症的新治疗方法。
Cardiovasc Drugs Ther. 2018 Feb;32(1):99-119. doi: 10.1007/s10557-017-6767-5.
4
Revisiting RAAS blockade in CKD with newer potassium-binding drugs.重新审视新型钾结合药物在 CKD 中的 RAAS 阻断作用。
Kidney Int. 2018 Feb;93(2):325-334. doi: 10.1016/j.kint.2017.08.038. Epub 2017 Dec 21.
5
Potassium Homeostasis in Health and Disease: A Scientific Workshop Cosponsored by the National Kidney Foundation and the American Society of Hypertension.健康与疾病中的钾稳态:由国家肾脏基金会和美国高血压学会联合主办的科学研讨会。
Am J Kidney Dis. 2017 Dec;70(6):844-858. doi: 10.1053/j.ajkd.2017.09.003. Epub 2017 Oct 10.
6
An Integrated View of Potassium Homeostasis.钾稳态的综合观点。
N Engl J Med. 2015 Jul 2;373(1):60-72. doi: 10.1056/NEJMra1313341.
7
Maintenance of serum potassium with sodium zirconium cyclosilicate (ZS-9) in heart failure patients: results from a phase 3 randomized, double-blind, placebo-controlled trial.心力衰竭患者使用环硅锆酸钠(ZS-9)维持血清钾水平:一项3期随机、双盲、安慰剂对照试验的结果
Eur J Heart Fail. 2015 Oct;17(10):1050-6. doi: 10.1002/ejhf.300. Epub 2015 Jun 16.
8
A phase 2 study on the treatment of hyperkalemia in patients with chronic kidney disease suggests that the selective potassium trap, ZS-9, is safe and efficient.一项针对慢性肾病患者高钾血症治疗的2期研究表明,选择性钾离子捕获剂ZS-9安全且有效。
Kidney Int. 2015 Aug;88(2):404-11. doi: 10.1038/ki.2014.382. Epub 2015 Feb 4.
9
Characterization of structure and function of ZS-9, a K+ selective ion trap.钾离子选择性离子阱ZS-9的结构与功能表征
PLoS One. 2014 Dec 22;9(12):e114686. doi: 10.1371/journal.pone.0114686. eCollection 2014.
10
Sodium zirconium cyclosilicate in hyperkalemia.硅酸锆钠治疗高钾血症。
N Engl J Med. 2015 Jan 15;372(3):222-31. doi: 10.1056/NEJMoa1411487. Epub 2014 Nov 21.