研究人员进行一项多中心二阶段的双盲3期试验,对比接受不同剂量环状硅酸锆(ZS-9)对降低高钾血症病人血钾的效果,发现病人接受ZS-9治疗后在第48小时,血钾水平明显降低;在维持治疗的12天中,血钾水平均保持正常。

                                                                                                                                                                      —2014年11月21日《新英格兰医学杂志》

中文译文


【题目】环状硅酸锆治疗高钾血症

【译文】
背景:高钾血症(血清钾水平 >5.0 mmol/L)与心衰、慢性肾病和糖尿病病人的死亡率增加有关。我们研究新型的选择性阳离子交换器——环状硅酸锆(ZS-9)是否能降低高钾血症病人的血清钾水平。
方法:在一个多中心二阶段的双盲3期试验中,我们对753个高钾血症病人进行随机分配,接受ZS-9(剂量为1.25g, 2.5g, 5g和10g)或安慰剂治疗,每天3次,使用48小时。血钾正常(3.5-4.9 mmol/L)的病人在第48小时进行随机分配,在第3到14天接受ZS-9或安慰剂治疗,每日1次。主要终点是第48小时平均血钾水平的指数变化率。
结果:在第48小时,在接受2.5g ZS-9病例组,平均血钾水平从基本水平5.3mmol/L降至4.9mmol/L;5g 病例组降至4.8mmol/L;10g 病例组降至4.6mmol/L;各组分别平均减少0.5、0.5、0.7mmol/L(P均<0.001);1.25g 病例组和安慰剂组降至5.1mmol/L(平均降低0.3mmol/L)。在分别接受5g和10g ZS-9治疗的病人,在第3到15天,血钾水平分别保持在4.7mmol/L和4.5mmol/L水平,而安慰剂组的血钾高于5.0mmol/L(P均<0.001)。ZS-9组和安慰剂组出现副反应事件的比率相同(初始阶段分别为12.9%和10.8%,维持阶段分别为25.1%和24.5%)。腹泻是两组最常见的并发症。
结论:与对照组相比,高钾血症病人接受ZS-9治疗后在第48小时,血钾水平明显降低;在维持治疗的12天中,血钾水平均保持正常。

 

英文原稿


[Title] Sodium Zirconium Cyclosilicate in Hyperkalemia

[Authors] Packham DK, Rasmussen HS, Lavin PT, El-Shahawy MA, Roger SD, Block G, Qunibi W, Pergola P, Singh B.
[Abstract]
BACKGROUND: Hyperkalemia (serum potassium level, >5.0 mmol per liter) is associated with increased mortality among patients with heart failure, chronic kidney disease, or diabetes. We investigated whether sodium zirconium cyclosilicate (ZS-9), a novel selective cation exchanger, could lower serum potassium levels in patients with hyperkalemia.
METHODS: In this multicenter, two-stage, double-blind, phase 3 trial, we randomly assigned 753 patients with hyperkalemia to receive either ZS-9 (at a dose of 1.25 g, 2.5 g, 5 g, or 10 g) or placebo three times daily for 48 hours. Patients with normokalemia (serum potassium level, 3.5 to 4.9 mmol per liter) at 48 hours were randomly assigned to receive either ZS-9 or placebo once daily on days 3 to 14. The primary end point was the exponential rate of change in the mean serum potassium level at 48 hours.
RESULTS: At 48 hours, the mean serum potassium level had decreased from 5.3 mmol per liter at baseline to 4.9 mmol per liter in the group of patients who received 2.5 g of ZS-9, 4.8 mmol per liter in the 5-g group, and 4.6 mmol per liter in the 10-g group, for mean reductions of 0.5, 0.5, and 0.7 mmol per liter, respectively (P<0.001 for all comparisons) and to 5.1 mmol per liter in the 1.25-g group and the placebo group (mean reduction, 0.3 mmol per liter). In patients who received 5 g of ZS-9 and those who received 10 g of ZS-9, serum potassium levels were maintained at 4.7 mmol per liter and 4.5 mmol per liter, respectively, during days 3 to 15, as compared with a level of more than 5.0 mmol per liter in the placebo group (P<0.01 for all comparisons). Rates of adverse events were similar in the ZS-9 group and the placebo group (12.9% and 10.8%, respectively, in the initial phase; 25.1% and 24.5%, respectively, in the maintenance phase). Diarrhea was the most common complication in the two study groups.
CONCLUSIONS: Patients with hyperkalemia who received ZS-9, as compared with those who received placebo, had a significant reduction in potassium levels at 48 hours, with normokalemia maintained during 12 days of maintenance therapy.

 

原文网址:
http://www.nejm.org/doi/full/10.1056/NEJMoa1411487

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