低钠饮食联合螺内酯治疗 1-3a 期慢性肾脏病患者的疗效及安全性：一项初步研究。
Efficacy and safety of a low-sodium diet and spironolactone in patients with stage 1-3a chronic kidney disease: a pilot study.
机构信息
Department of Nephrology, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University, 453 Tiyuchang Road, Hangzhou, 310007, China.
出版信息
BMC Nephrol. 2022 Mar 5;23(1):95. doi: 10.1186/s12882-022-02711-z.
BACKGROUND
Excessive salt intake is associated with the deterioration of chronic kidney disease (CKD). Aldosterone is also known as an independent risk factor for kidney injury. Dietary sodium intake acts as a main stimulator in aldosterone-mediated kidney injury. Hence, this study aimed to further investigate the renal protective effects and safety of a low-sodium diet in combination with spironolactone (SPL) in stage 1-3a CKD.
METHODS
This single-center, SPL-blinded randomized controlled trial recruited patients with stage 1-3a CKD, randomized into three groups, low-sodium (3 g/d salt) + placebo, medium-sodium (5 g/d salt) + SPL, and low-sodium (3 g/d salt) + SPL. Patients received 12 weeks of intervention. The primary and secondary endpoints were 24-h urine protein and estimated glomerular filtration rate (eGFR) at the end of the intervention, respectively.
RESULTS
A total of 74 patients were analyzed eventually. Significantly decreased 24-h urine protein was found in all three groups, from 0.37 to 0.23 g/d (P = 0.004) in the low-sodium+placebo group, from 0.44 to 0.29 g/d (P = 0.020) in the medium-sodium+SPL group, and from 0.35 to 0.31 g/d (P = 0.013) in the low-sodium +SPL group. There were no significant differences among the three groups in 24-h urine protein amount change after intervention from pre-treatment values (P = 0.760, ITT set). The results of the 24-h urine protein by using PP set analysis was similar to the ITT set. No significant differences in eGFR, nutritional, metabolic, inflammatory, and other biomarkers were observed across all three groups (P > 0.05). No safety signal was observed.
CONCLUSION
No additional benefit was observed when SPL was prescribed to patients already on a low-sodium diet (3.0 g/d). Still, small doses of SPL may benefit patients with poor sodium restriction. A combination of short-term low-dose SPL and ARB is safe for patients with stage 1-3a CKD, but blood potassium must be regularly monitored.
TRIAL REGISTRATION
Name of the registry: Chinese clinical trial registry.
TRIAL REGISTRATION NUMBER
ChiCTR1900026991. Date of registration: Retrospectively registered 28 October 2019. URL of trial registry record: http://www.chictr.org.cn/searchproj.aspx?title=&officialname=&subjectid=&secondaryid=&applier=&studyleader=ðicalcommitteesanction=&spo.
背景
过量的盐摄入与慢性肾脏病（CKD）的恶化有关。醛固酮也被认为是肾脏损伤的一个独立危险因素。膳食钠摄入量是醛固酮介导的肾脏损伤的主要刺激因素。因此，本研究旨在进一步探讨低钠饮食联合螺内酯（SPL）在 1-3a 期 CKD 患者中的肾脏保护作用和安全性。
方法
这是一项单中心、SPL 设盲的随机对照试验，招募了 1-3a 期 CKD 患者，随机分为三组，低钠（3g/d 盐）+安慰剂、中钠（5g/d 盐）+SPL 和低钠（3g/d 盐）+SPL。患者接受 12 周的干预。主要和次要终点分别为干预结束时的 24 小时尿蛋白和估算肾小球滤过率（eGFR）。
结果
最终分析了 74 例患者。所有三组的 24 小时尿蛋白均显著下降，从低钠+安慰剂组的 0.37 降至 0.23g/d（P=0.004），从中钠+SPL 组的 0.44 降至 0.29g/d（P=0.020），从低钠+SPL 组的 0.35 降至 0.31g/d（P=0.013）。从治疗前值到干预后 24 小时尿蛋白量变化，三组间无显著差异（P=0.760，ITT 集）。PP 集分析的 24 小时尿蛋白结果与 ITT 集相似。三组间 eGFR、营养、代谢、炎症等生物标志物均无显著差异（P>0.05）。未观察到安全性信号。
结论
对于已经接受低钠饮食（3.0g/d）的患者，给予 SPL 并没有额外的益处。然而，小剂量的 SPL 可能对钠限制不良的患者有益。短期小剂量 SPL 联合 ARB 治疗 1-3a 期 CKD 患者是安全的，但必须定期监测血钾。
试验注册
名称：中国临床试验注册中心。
试验注册号
ChiCTR1900026991。注册日期：2019 年 10 月 28 日。试验注册网址：http://www.chictr.org.cn/searchproj.aspx?title=&officialname=&subjectid=&secondaryid=&applier=&studyleader=&institutionreviewboardapproval=&sponsor=&funding=&funding_source=&briefsummary=&startdate=&enddate=&condition=&keyword=&ncit_cancer_staging_system=&ncit_cancer_stage_group=&ncit_cancer_stage_number=&ncit_cancer_stage_semantics=&search_type=0。
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