Wang Jing, Lv Meng-Meng, Zach Odeh, Wang Ling-Yu, Zhou Meng-Ying, Song Gui-Rong, Zhang Xu, Lin Hong-Li
Graduate School of Dalian Medical University, Dalian, China.
Department of Nephrology, Liaoning Translational Medicine Center of Nephrology, the First Affiliated Hospital of Dalian Medical University, Dalian, China.
Ther Apher Dial. 2018 Dec;22(6):609-616. doi: 10.1111/1744-9987.12723. Epub 2018 Aug 14.
Hyperkalemia is a life-threatening emergency in maintenance hemodialysis (MHD) patients. This clinical trial investigated the efficacy and safety of calcium-polystyrene sulfonate (Ca-PS) in MHD patients with interdialytic hyperkalemia. A total of 58 hemodialysis patients with hyperkalemia (≥5.5 mol/L) were selected and administered either a 3-week Ca-PS (3 × 5 g/day) or a blank control following the model of a prospective, randomized, crossover clinical trial with a 1-week washout period. All patients were followed up for another 3 weeks for safety evaluations. The primary outcome was the magnitude of the change in serum potassium levels. The secondary outcomes were electrocardiography (ECG) changes and treatment safety (volume overload, electrolyte imbalance). Compared with the control group, Ca-PS treatment significantly reduced serum potassium levels (P <0.01). More patients in the Ca-PS group had lower serum potassium levels than the safety level of <5.5 mmol/L (32% for control vs. 61% for Ca-PS, P <0.01). Peaked T-wave occurred less frequently in patients in the Ca-PS group (13.8% for Ca-PS vs. 31.03% for control, P <0.01). In addition, Ca-PS reduced serum phosphorus levels with no effects on serum levels of calcium and sodium, fluid volume, blood pressure, or interdialytic weight gain. Ca-PS treatment decreases serum levels of potassium and phosphorus in MHD patients with interdialytic hyperkalemia. Ca-PS does not induce volume overload or disrupt electrolyte balance.
高钾血症是维持性血液透析(MHD)患者危及生命的紧急情况。本临床试验研究了聚苯乙烯磺酸钙(Ca-PS)在伴有透析间期高钾血症的MHD患者中的疗效和安全性。按照前瞻性、随机、交叉临床试验模式,选择58例高钾血症(≥5.5 mol/L)血液透析患者,给予3周Ca-PS(3×5 g/天)或空白对照,有1周洗脱期。所有患者再随访3周进行安全性评估。主要结局是血清钾水平变化幅度。次要结局是心电图(ECG)变化和治疗安全性(容量超负荷、电解质失衡)。与对照组相比,Ca-PS治疗显著降低血清钾水平(P <0.01)。Ca-PS组血清钾水平低于<5.5 mmol/L安全水平的患者更多(对照组为32%,Ca-PS组为61%,P <0.01)。Ca-PS组患者出现尖峰T波的频率较低(Ca-PS组为13.8%,对照组为31.03%,P <0.01)。此外,Ca-PS降低血清磷水平,对血清钙、钠水平、液体量、血压或透析间期体重增加无影响。Ca-PS治疗可降低伴有透析间期高钾血症的MHD患者的血清钾和磷水平。Ca-PS不会导致容量超负荷或破坏电解质平衡。