碳酸氢钠治疗对中年及老年慢性肾脏病患者认知和脑血管功能的影响：一项初步随机试验
Effects of sodium bicarbonate therapy on cognitive and cerebrovascular function in midlife and older adults with chronic kidney disease: a pilot randomized trial.
作者信息
Gu Fangning, You Zhiying, Hawkins Nell, Reddin Rachael, Hamour Rahaf, Shapiro Allison, Coughlan Christina, Seals Douglas, Furgeson Seth, Dixon Angelina, Nowak Kristen L, Kendrick Jessica
机构信息
Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, CO, 80045, USA.
Department of Pediatrics, Section of Pediatric Endocrinology, Children's Hospital Colorado, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
出版信息
BMC Nephrol. 2025 Aug 12;26(1):454. doi: 10.1186/s12882-025-04388-6.
INTRODUCTION
Metabolic acidosis may create a pathway to cognitive impairment in chronic kidney disease (CKD) by contributing to cerebrovascular dysfunction. Trials examining the effect of sodium bicarbonate (NaHCO) on cognitive function are lacking.
METHODS
We conducted a randomized, double-blind, placebo-controlled pilot study examining the effect of 12 months of NaHCO on cognitive function in 34 patients aged 50-80 years with CKD stage 3b-4 (eGFR 15-44 ml/min/1.73m) with metabolic acidosis (serum bicarbonate level 16-22 mEq/L). Participants were randomized 1:1 to NaHCO or placebo. The primary endpoint was change in overall cognition (Cognitive Function Composite score) assessed by the NIH Toolbox® Cognition Battery over 12 months. Secondary endpoints were change in cerebrovascular reactivity and pulsatility of the middle cerebral artery (MCA) assessed by Transcranial Doppler Ultrasonography over 12 months.
RESULTS
33 patients completed the study. After 12 months of treatment with NaHCO therapy, the Cognitive Function Composite score increased significantly from baseline (mean ± SD, 47.3 ± 8.5 to 49.3 ± 11.0, p = 0.03), however, there was no difference compared to placebo (p = 0.39). NaHCO therapy resulted in a significant reduction in time to perform the Trail Making Test-A (median [IQR], 31.3 [27.0, 36.3] to 29.0 [19.4, 38.2] seconds, p = 0.02), however there was no difference compared to placebo (p = 0.29). After 12 months of treatment, there was a significant increase in resting pulsatility index of the MCA in the placebo group, but there were no statistical differences between groups (p = 0.71). NaHCO treatment resulted in a significant decrease in baseline mean blood flow velocity of the MCA (p = 0.03), but there was no difference from placebo (p = 0.11).
CONCLUSIONS
Although there were trends supporting a role for sodium bicarbonate in having an effect on cognitive function, this was not significant in this underpowered study. A larger study is recommended.
TRIAL REGISTRATION
Clinicaltrials.gov (NCT04600323) on 10/19/2020.
引言
代谢性酸中毒可能通过导致脑血管功能障碍，为慢性肾脏病（CKD）的认知障碍创造一条途径。目前缺乏关于碳酸氢钠（NaHCO₃）对认知功能影响的试验。
方法
我们进行了一项随机、双盲、安慰剂对照的试点研究，以检验12个月的NaHCO₃对34例年龄在50 - 80岁、患有3b - 4期CKD（估算肾小球滤过率[eGFR]为15 - 44 ml/min/1.73m²）且伴有代谢性酸中毒（血清碳酸氢盐水平为16 - 22 mEq/L）患者认知功能的影响。参与者按1:1随机分为NaHCO₃组或安慰剂组。主要终点是通过美国国立卫生研究院（NIH）工具箱认知电池在12个月内评估的总体认知变化（认知功能综合评分）。次要终点是通过经颅多普勒超声在12个月内评估的脑血管反应性和大脑中动脉（MCA）搏动性的变化。
结果
33例患者完成了研究。在接受NaHCO₃治疗12个月后，认知功能综合评分较基线显著增加（均值±标准差，从47.3±8.5增至49.3±11.0，p = 0.03），然而，与安慰剂组相比无差异（p = 0.39）。NaHCO₃治疗使完成连线测验A的时间显著缩短（中位数[四分位间距]，从31.3[27.0, 36.3]秒降至29.0[19.4, 38.2]秒，p = 0.02），但与安慰剂组相比无差异（p = 0.29）。治疗12个月后，安慰剂组MCA的静息搏动指数显著增加，但两组间无统计学差异（p = 0.71）。NaHCO₃治疗使MCA的基线平均血流速度显著降低（p = 0.03），但与安慰剂组相比无差异（p = 0.11）。
结论
尽管有趋势支持碳酸氢钠对认知功能有影响，但在这项样本量不足的研究中这并不显著。建议进行更大规模的研究。
试验注册
Clinicaltrials.gov（NCT04600323），于2020年10月19日注册。
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