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帕替罗姆与聚苯乙烯磺酸钠对慢性血液透析患者血钾水平的比较疗效:一项随机交叉试验。

Comparative efficacy of patiromer and sodium polystyrene sulfonate on potassium levels in chronic haemodialysis patients: a randomized crossover trial.

作者信息

Jaques David A, Stucker Fabien, Ernandez Thomas, Alves Cyrielle, Martin Pierre-Yves, De Seigneux Sophie, Saudan Patrick

机构信息

Division of Nephrology, Geneva University Hospitals, Geneva, Switzerland.

Division of Nephrology, Hôpital de la Providence, Neuchâtel, Switzerland.

出版信息

Clin Kidney J. 2022 May 10;15(10):1908-1914. doi: 10.1093/ckj/sfac129. eCollection 2022 Oct.

Abstract

BACKGROUND

Hyperkalaemia is frequent in haemodialysis (HD) patients and associated with increased cardiovascular mortality. Despite routine clinical use, evidence regarding the efficacy of potassium (K) binders in HD is scant. We wished to compare the efficacy of patiromer (PAT) and sodium polystyrene sulfonate (SPS) on K levels in this setting.

METHODS

We screened patients in three HD centres with pre-HD K value between 5.0 and 6.4 mmol/L, after an initial 2-week washout period for those previously on K binders. We included patients in an unblinded two-arm crossover trial comparing SPS 15 g before each meal on non-dialysis days with PAT 16.8 g once daily on non-dialysis days with randomized attribution order and a 2-week intermediate washout period. The primary outcome was the mean weekly K value.

RESULTS

We included 51 patients and analysed 48 with mean age of 66.4 ± 19.4 years, 72.9% men and 43.4% diabetics. Mean weekly K values were 5.00 ± 0.54 mmol/L, 4.55 ± 0.75 mmol/L and 5.17 ± 0.64 mmol/L under PAT ( = .003), SPS ( < .001) and washout, respectively. In direct comparison, K values and prevalence of hyperkalaemia were lower under SPS as compared with PAT ( < .001). While the incidence of gastrointestinal side effects was similar between treatments, SPS showed lower subjective tolerability score (6.0 ± 2.4 and 6.9 ± 1.9) and compliance (10.8 ± 20.4% and 2.4 ± 7.3% missed doses) as compared with PAT ( < .001 for both).

CONCLUSION

Both PAT and SPS are effective in decreasing K levels in chronic HD patients. However, at the tested doses, SPS was significantly more effective in doing so as compared with PAT, despite lower tolerability and compliance. Larger randomized controlled trials should be conducted in order to confirm our findings and determine whether they would impact clinical outcomes.

摘要

背景

高钾血症在血液透析(HD)患者中很常见,且与心血管死亡率增加相关。尽管钾结合剂在临床中常规使用,但关于其在血液透析中疗效的证据却很少。我们希望比较在这种情况下帕替罗莫(PAT)和聚苯乙烯磺酸钠(SPS)对血钾水平的疗效。

方法

我们在三个血液透析中心筛选了透析前血钾值在5.0至6.4 mmol/L之间的患者,对于之前使用过钾结合剂的患者,先经过为期2周的洗脱期。我们将患者纳入一项非盲双臂交叉试验,比较非透析日每餐饭前服用15 g SPS与非透析日每日服用一次16.8 g PAT,随机分配给药顺序,并设有为期2周的中间洗脱期。主要结局指标是每周血钾均值。

结果

我们纳入了51例患者,分析了48例,平均年龄为66.4±19.4岁,男性占72.9%,糖尿病患者占43.4%。在服用PAT(P = 0.003)、SPS(P < 0.001)及洗脱期时,每周血钾均值分别为5.00±0.54 mmol/L、4.55±0.75 mmol/L和5.17±0.64 mmol/L。直接比较时,与PAT相比,SPS治疗时血钾值及高钾血症患病率更低(P < 0.001)。虽然各治疗组胃肠道副作用发生率相似,但与PAT相比,SPS的主观耐受性评分更低(分别为6.0±2.4和6.9±1.9),依从性也更低(漏服剂量分别为10.8±20.4%和2.4±7.3%)(两者P均< 0.001)。

结论

PAT和SPS均可有效降低慢性血液透析患者的血钾水平。然而,在测试剂量下,尽管SPS耐受性和依从性较低,但与PAT相比,其降低血钾水平的效果显著更优。应开展更大规模的随机对照试验以证实我们的研究结果,并确定其是否会影响临床结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0329/9494516/218fc3e6ab76/sfac129fig1g.jpg

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