D'Haese Patrick C, Spasovski Goce B, Sikole Aleksander, Hutchison Alastair, Freemont Tony J, Sulkova Sylvie, Swanepoel Charles, Pejanovic Svetlana, Djukanovic Llubica, Balducci Alessandro, Coen Giorgio, Sulowicz Waldysaw, Ferreira Anibal, Torres Armando, Curic Slobodan, Popovic Milan, Dimkovic Nada, De Broe Marc E
Department of Nephrology-Hypertension, University of Antwerp, Belgium.
Kidney Int Suppl. 2003 Jun(85):S73-8. doi: 10.1046/j.1523-1755.63.s85.18.x.
Lanthanum carbonate (LC) (Fosrenol) is a novel new treatment for hyperphosphatemia. In this phase III, open-label study, we compared the effects of LC and calcium carbonate (CC) on the evolution of renal osteodystrophy (ROD) in dialysis patients.
Ninety-eight patients were randomized to LC (N = 49) or CC (N = 49). Bone biopsies were taken at baseline and after one year of treatment. Acceptable paired biopsies were available for static and dynamic histomorphometry studies in 33 LC and 30 CC patients. Blood samples were taken at regular intervals for biochemical analysis and adverse events were monitored.
LC was well tolerated and serum phosphate levels were well controlled in both treatment groups. The incidence of hypercalcemia was lower in the LC group (6% vs. 49% for CC). At baseline, subtypes of ROD were similarly distributed in both groups, with mixed ROD being most common. At one-year follow-up in the LC group, 5 of 7 patients with baseline low bone turnover (either adynamic bone or osteomalacia), and 4 of 5 patients with baseline hyperparathyroidism, had evolved toward a normalization of their bone turnover. Only one lanthanum-treated patient evolved toward adynamic bone compared with 6 patients in the CC group. In the LC group, the number of patients having either adynamic bone, osteomalacia, or hyperpara decreased overall from 12 (36%) at baseline to 6 (18%), while in the calcium group, the number of patients with these types of ROD increased from 13 (43%) to 16 (53%).
LC is a poorly absorbed, well-tolerated, and efficient phosphate binder. LC-treated dialysis patients show almost no evolution toward low bone turnover over one year (unlike CC-treated patients), nor do they experience any aluminum-like effects on bone.
碳酸镧（LC）（福斯利诺）是一种治疗高磷血症的新型药物。在这项III期开放标签研究中，我们比较了LC和碳酸钙（CC）对透析患者肾性骨营养不良（ROD）进展的影响。
98例患者被随机分为LC组（N = 49）或CC组（N = 49）。在基线期和治疗一年后进行骨活检。33例LC组患者和30例CC组患者的配对活检样本可用于静态和动态组织形态计量学研究。定期采集血样进行生化分析，并监测不良事件。
两个治疗组对LC的耐受性均良好，血清磷酸盐水平得到良好控制。LC组高钙血症的发生率较低（6%，而CC组为49%）。在基线期，两组ROD的亚型分布相似，混合性ROD最为常见。在LC组一年的随访中，7例基线期骨转换率低（动力缺失性骨或骨软化症）的患者中有5例，以及5例基线期甲状旁腺功能亢进的患者中有4例，其骨转换率已恢复正常。与CC组的6例患者相比，接受镧治疗的患者中只有1例发展为动力缺失性骨。在LC组，患有动力缺失性骨、骨软化症或甲状旁腺功能亢进的患者总数从基线期的12例（36%）降至6例（18%），而在钙组，这些类型ROD的患者数量从13例（43%）增加至16例（53%）。
LC是一种吸收性差、耐受性良好且有效的磷酸盐结合剂。接受LC治疗的透析患者在一年中几乎没有发展为低骨转换率（与接受CC治疗的患者不同），也未出现任何类似铝对骨骼的影响。
