Hospital Marques de Valdecilla, Universidad de Cantabria, Santander, Spain.
Nephrol Dial Transplant. 2010 Nov;25(11):3707-17. doi: 10.1093/ndt/gfq292. Epub 2010 Jun 7.
Phosphate binders are required to control serum phosphorus in dialysis patients. A phosphate binder combining calcium and magnesium offers an interesting therapeutic option.
This controlled randomized, investigator-masked, multicentre trial investigated the effect of calcium acetate/magnesium carbonate (CaMg) on serum phosphorus levels compared with sevelamer hydrochloride (HCl). The study aim was to show non-inferiority of CaMg in lowering serum phosphorus levels into Kidney Disease Outcome Quality Initiative (K/DOQI) target level range after 24 weeks. Three hundred and twenty-six patients from five European countries were included. After a phosphate binder washout period, 255 patients were randomized in a 1:1 fashion. Two hundred and four patients completed the study per protocol (CaMg, N = 105; dropouts N = 18; sevelamer-HCl, N = 99; dropouts N = 34). Patient baseline characteristics were similar in both groups.
Serum phosphorus levels had decreased significantly with both drugs at week 25, and the study hypothesis of CaMg not being inferior to sevelamer-HCl was confirmed. The area under the curve for serum phosphorus (P = 0.0042) and the number of visits above K/DOQI (≤1.78 mmol/L, P = 0.0198) and Kidney disease: Improving global outcomes (KDIGO) targets (≤1.45 mmol/L, P = 0.0067) were significantly lower with CaMg. Ionized serum calcium did not differ between groups; total serum calcium increased in the CaMg group (treatment difference 0.0477 mmol/L; P = 0.0032) but was not associated with a higher risk of hypercalcaemia. An asymptomatic increase in serum magnesium occurred in CaMg-treated patients (treatment difference 0.2597 mmol/L, P < 0.0001). There was no difference in the number of patients with adverse events.
CaMg was non-inferior to the comparator at controlling serum phosphorus levels at Week 25. There was no change in ionized calcium; there was minimal increase in total serum calcium and a small increase in serum magnesium. It had a good tolerability profile and thus may represent an effective treatment of hyperphosphataemia.
磷结合剂是透析患者控制血清磷所必需的。钙镁结合的磷结合剂提供了一种有趣的治疗选择。
本研究为一项对照、随机、研究者设盲、多中心试验，旨在评估醋酸钙/碳酸镁（CaMg）与盐酸司维拉姆（HCl）相比，在降低血清磷水平方面的疗效，以达到肾脏病预后质量倡议（K/DOQI）目标范围。该研究的主要目的是证明在 24 周时，CaMg 在降低血清磷水平方面不劣于 HCl。来自欧洲五个国家的 326 名患者参与了该研究。经过磷结合剂洗脱期后，255 名患者以 1:1 的比例随机分组。204 名患者按方案完成了研究（CaMg 组：N = 105；脱落：N = 18；司维拉姆-HCl 组：N = 99；脱落：N = 34）。两组患者的基线特征相似。
两组患者在第 25 周时血清磷水平均显著下降，且 CaMg 不劣于司维拉姆-HCl 的研究假设得到了验证。血清磷的曲线下面积（P = 0.0042）以及超过 K/DOQI（≤1.78mmol/L，P = 0.0198）和肾脏病：改善全球结果（KDIGO）（≤1.45mmol/L，P = 0.0067）的就诊次数均显著低于 CaMg 组。两组间离子钙无差异；CaMg 组总血清钙增加（治疗差异 0.0477mmol/L；P = 0.0032），但与高钙血症风险增加无关。CaMg 治疗的患者血清镁出现无症状升高（治疗差异 0.2597mmol/L，P<0.0001）。两组患者不良事件的发生次数无差异。
CaMg 在第 25 周时控制血清磷水平与对照药物相当。离子钙无变化；总血清钙略有增加，血清镁略有增加。其具有良好的耐受性，因此可能是治疗高磷血症的有效方法。
