环硅酸锆钠（Lokelma）使acei / arb用于糖尿病肾病患者的治疗。

IF 7.4 3区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes research and clinical practice Pub Date : 2025-08-09 DOI:10.1016/j.diabres.2025.112413

Xu Hao , Jian Liu , Leyi Gu , Xiujuan Zang , Na Liu , Yangbin Pan , Chunming Jiang , Ying Li , Gengru Jiang , Zhiguo Mao , Jun Xue , Rong Zhou , Weiming Wang

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引用次数: 0

摘要

目的：在糖尿病肾病（DKD）中，血管紧张素转换酶抑制剂(ACEIs)/血管紧张素受体阻滞剂（ARBs）是关键的治疗方法，但可能导致高钾血症。本随机对照试验（RCT）首次评估了环硅酸锆钠（SZC）优化肾素-血管紧张素-醛固酮系统抑制剂（RAASi）在DKD中的应用，解决了该领域的证据空白。方法：这项为期24周的前瞻性多中心研究纳入了86例有SZC + ACEIs/ arb或单独使用ACEIs/ arb的高钾血症风险的DKD患者。主要结局：第12周ACEIs/ arb剂量增加。探索性结果包括尿白蛋白与肌酐比（UACR）、血清肌酐和血压（BP）。结果:在12周,55.81 %的患者SZC + acei / arb手臂up-titrated acei / arb剂量(95 %可信区间[CI]: 39.88 % -70.92 %),相比27.91 % acei / arb手臂(95 % CI: 15.33  % % -43.67,P = 0.009)。在第24周，SZC + ACEIs/ARBs组的UACR下降了63.46 mg/g，而ACEIs/ARBs组的UACR增加了316.87 mg/g(最小二乘平均差[LSMD]: -333.63 mg/g[95 % CI: -1148.73至481.47]；按方案组)。SZC + ACEIs/ARBs组血压下降幅度更大(收缩压：-1.7 mmHg；舒张期:-1.4 毫米汞柱)。结论：SZC降低了高钾血症相关的RAASi停药风险，改善了蛋白尿和血压，支持DKD患者在RAASi中预防性使用SZC。

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Sodium zirconium cyclosilicate (Lokelma) to enable ACEIs/ARBs use in the treatment of patients with diabetic kidney disease

Aims

In diabetic kidney disease (DKD), Angiotensin-converting enzyme inhibitors (ACEIs)/ angiotensin receptor blockers (ARBs) are key treatments but may cause hyperkalemia. This randomized controlled trial (RCT) firstly evaluates sodium zirconium cyclosilicate (SZC) to optimize renin-angiotensin-aldosterone system inhibitor (RAASi) use in DKD, addressing evidence gaps in this field.

Methods

This 24-weeks prospective multicenter study enrolled 86 DKD patients at hyperkalemia risk to SZC + ACEIs/ARBs or ACEIs/ARBs alone. Primary outcome: ACEIs/ARBs dose up-titration at week 12. Exploratory outcomes included urinary albumin-to-creatinine ratio (UACR), serum creatinine, and blood pressure (BP).

Results

At week 12, 55.81 % of patients in the SZC + ACEIs/ARBs arm up-titrated their ACEIs/ARBs dosage (95 % confidence interval [CI]: 39.88 %-70.92 %), compared to 27.91 % in the ACEIs/ARBs arm (95 % CI: 15.33 %-43.67 %, P = 0.009). UACR decreased by 63.46 mg/g in the SZC + ACEIs/ARBs arm at week 24, while increasing by 316.87 mg/g in the ACEIs/ARBs arm (least squares mean difference [LSMD]: –333.63 mg/g [95 % CI: −1148.73 to 481.47]; Per-Protocol Set). BP reductions were greater numerically in the SZC + ACEIs/ARBs arm (systolic: −1.7 mmHg; diastolic: −1.4 mmHg).

Conclusions

SZC reduced hyperkalemia-related RAASi discontinuation risk, improved proteinuria and BP, supporting its prophylactic use in DKD patients on RAASi.

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来源期刊

Diabetes research and clinical practice 医学-内分泌学与代谢

CiteScore

10.30

自引率

3.90%

发文量

862

审稿时长

32 days

期刊介绍： Diabetes Research and Clinical Practice is an international journal for health-care providers and clinically oriented researchers that publishes high-quality original research articles and expert reviews in diabetes and related areas. The role of the journal is to provide a venue for dissemination of knowledge and discussion of topics related to diabetes clinical research and patient care. Topics of focus include translational science, genetics, immunology, nutrition, psychosocial research, epidemiology, prevention, socio-economic research, complications, new treatments, technologies and therapy.