【摘要】 目的 评估聚苯乙烯磺酸钙（CPS）和聚苯乙烯磺酸钠（SPS）在中国肾功能不全患者高钾血症（HK）治疗中的安全性、耐受性、治疗模式和有效性。方法以中国26家医院有HK的慢性肾病（CKD）或急性肾损伤（AKI）患者纳入为研究对象。研究共定义2个全分析集（FAS）,FAS-P1（阶段1，随访3 d）和FAS-P2（阶段2，随访6个月）。FAS-P1包括在CPS/SPS起始治疗后1～3 d服用至少1剂CPS/SPS的所有新使用者，FAS-P2包括正在使用者组中入组后至少接受1剂CPS/SPS的所有患者，以及新使用者（FAS-P1）中起始治疗期完成后至少接受1剂CPS/SPS的患者。观察2个数据集的用药情况、血清钾（s K⁺）水平及临床疗效，并进行安全性评价。结果 研究共筛选892例患者，FAS-P1和FAS-P2分别纳入390例（CPS 385例，SPS 5例）和814例（CPS 811例，SPS 3例）患者。FAS-P1和FAS-P2中，患者的CPS日均剂量分别为（7.28±6.24）和（5.13±5.15） g,SPS日均剂量分别为（10.75±6.23）和（8.36±7.59） g。FAS-P1中，s K⁺从基线至第3天的变化值为（-0.72±0.61） mmol·L^-1; FAS-P2中，研究期间患者s K⁺均值为（5.17±0.68） mmol·L^-1（95%CI:5.12～5.22）。FAS-P1和FAS-P2中，分别有56.15%和55.16%的患者发生了不良事件（AEs），严重不良事件（SAEs）发生率分别为29.23%和29.24%。经研究者判定与CPS/SPS相关的不良事件发生率较低，在FAS-P1和FAS-P2中分别为2.56%和2.09%。最常见的CPS/SPS相关AE为胃肠道不适（FAS-P1:2.05%; FAS-P2:1.70/100人-年）和低钾血症（FAS-P1:0.51%; FAS-P2:2.10/100人-年）。结论 本研究中，超过50%的肾功能不全合并高钾血症患者发生了AEs，反映了该人群疾病负担较重。但与CPS/SPS相关的AEs发生率较低（约2%），主要表现为胃肠道不适和低钾血症。更多还原

【Abstract】 Objective To evaluate the safety,tolerability,treatment patterns,and effectiveness of calcium polystyrene sulfonate（ CPS） and sodium polystyrene sulfonate（ SPS） in the management of hyperkalemia（ HK） among Chinese patients with renal insufficiency. Methods Patients with chronic kidney disease（ CKD） or acute kidney injury（ AKI） with HK in 26 hospitals in China were included in the study. Two full analysis sets（ FAS）,FAS-P1（ stage 1,followed up for 3 days）and FAS-P2（ stage 2,followed up for 6 months） were defined. Fas-P1 includes all new users taking at least one dose of CPS/SPS 1-3 days after the initial treatment of CPS/SPS,FAS-P2 includes all patients receiving at least one dose of CPS/SPS after enrollment in the user group,and patients receiving at least one dose of CPS/SPS after the initial treatment period in the new user（ Fas-P1）. The drug use,serum potassium（ s K⁺） level and clinical efficacy of the two data sets were observed,and the safety was evaluated. Results A total of 892 patients were selected in the study. 390 patients（ CPS 385 cases,SPS 5 cases） and 814 patients（ CPS 811 cases,SPS 3 cases） were included in FAS-P1 and FAS-P2,respectively. In FAS-P1 and FAS-P2,the average daily doses of CPS were（ 7. 28 ± 6. 24） and（ 5. 13 ± 5. 15） g, respectively; and the average daily doses of SPS were（ 10. 75 ± 6. 23） and（ 8. 36 ± 7. 59） g,respectively. In FAS-P1,the change of s K⁺from baseline to day 3 was（-0. 72 ±0. 61） mmol·L^-1; in FAS-P2,the mean value of s K⁺was（ 5. 17 ± 0. 68） mmol·L^-1（ 95% CI: 5. 12-5. 22）. In FAS-P1 and FAS-P2,56. 15% and 55. 16% patients had adverse events（ AEs）,respectively,and the incidence of serious adverse events（ SAEs） were 29. 23% and 29. 24%,respectively. The researchers determined that the incidence of adverse events related to CPS/SPS was low,which was 2. 56% in FAS-P1 and 2. 09% in FAS-P2.The most common CPS/SPS related AEs were gastrointestinal discomfort（ FAS-P1: 2. 05%; FAS-P2: 1. 70/100 person years） and hypokalemia（ FAS-P1: 0. 51%; FAS-P2: 2. 10/100 person years）. Conclusion In this study,over 50% of patients with renal insufficiency and hyperkalemia experienced AEs,reflecting the high burden of underlying disease in this population. However,the incidence of AEs related to CPS/SPS was low（ approximately2%）,predominantly presenting as gastrointestinal discomfort and hypokalemia.更多还原