Kaisar Mohammed O, Wiggins Kathryn J, Sturtevant Joanne M, Hawley Carmel M, Campbell Scott B, Isbel Nicole M, Mudge David W, Bofinger Andrew, Petrie James J B, Johnson David W
Department of Renal Medicine, University of Queensland, Princess Alexandra Hospital, Brisbane, QLD, Australia.
Am J Kidney Dis. 2006 May;47(5):809-14. doi: 10.1053/j.ajkd.2006.01.014.
Previous small uncontrolled studies suggested that fludrocortisone may significantly decrease serum potassium concentrations in hemodialysis patients, possibly through enhancement of colonic potassium secretion. The aim of this study is to evaluate the effect of oral fludrocortisone on serum potassium concentrations in hyperkalemic hemodialysis patients in an open-label randomized controlled trial.
Thirty-seven hemodialysis patients with predialysis hyperkalemia were randomly allocated to administration of either oral fludrocortisone (0.1 mg/d; n = 18) or no treatment (control; n = 19) for 3 months. The primary outcome measure was midweek predialysis serum potassium concentration, which was measured monthly during the trial. Prospective power calculations indicated that the study had an 80% probability of detecting a decrease in serum potassium levels of 0.7 mEq/L (0.7 mmol/L).
Baseline patient characteristics were similar, except for slightly longer total weekly dialysis hours in the fludrocortisone group (13.0 +/- 1.3 versus 12.1 +/- 1.0; P = 0.02). At the end of the study period, no significant changes in serum potassium concentrations were observed between the fludrocortisone and control groups (4.8 +/- 0.5 versus 5.2 +/- 0.7 mEq/L [mmol/L], respectively; P = 0.10). Similar results were obtained when changes in serum potassium levels over time were examined between the 2 arms by using repeated-measures analysis of variance, with or without adjustment for total weekly dialysis hours. Secondary outcomes, including predialysis mean arterial pressure, interdialytic weight gain, serum sodium level, and hospitalization for hyperkalemia, were not significantly different between groups. There were no observed adverse events.
Administering fludrocortisone to hyperkalemic hemodialysis patients is safe and well tolerated, but does not achieve clinically important decreases in serum potassium levels.
先前的小型非对照研究表明，氟氢可的松可能会显著降低血液透析患者的血清钾浓度，可能是通过增强结肠钾分泌来实现的。本研究的目的是在一项开放标签随机对照试验中评估口服氟氢可的松对高钾血症血液透析患者血清钾浓度的影响。
37例透析前血钾过高的血液透析患者被随机分为两组，一组口服氟氢可的松（0.1毫克/天；n = 18），另一组不接受治疗（对照组；n = 19），为期3个月。主要结局指标是透析前周中血清钾浓度，在试验期间每月测量一次。前瞻性功效计算表明，该研究有80%的概率检测出血清钾水平降低0.7毫当量/升（0.7毫摩尔/升）。
除氟氢可的松组的每周总透析时间略长外（13.0±1.3对12.1±1.0；P = 0.02），两组患者的基线特征相似。在研究期结束时，氟氢可的松组和对照组的血清钾浓度没有显著变化（分别为4.8±0.5和5.2±0.7毫当量/升[毫摩尔/升]；P = 0.10）。当使用重复测量方差分析比较两组随时间的血清钾水平变化时，无论是否对每周总透析时间进行调整，都得到了相似的结果。次要结局，包括透析前平均动脉压、透析间期体重增加、血清钠水平和高钾血症住院情况，两组之间没有显著差异。未观察到不良事件。
对高钾血症血液透析患者使用氟氢可的松是安全且耐受性良好的，但并未使血清钾水平出现具有临床意义的降低。
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