Inoue Toru, Nagatoya Katsuyuki, Kagitani Maki, Shibahara Nobuhisa, Ueda Haruhiko, Katsuoka Yoji, Ohashi Seiji, Kitagawa Yoshiyuki, Nishimoto Kazuhiko, Yasuda Hideaki
Blood Purification Center, Osaka College of Medicine, Osaka, Japan.
Ther Apher Dial. 2007 Jun;11(3):210-4. doi: 10.1111/j.1744-9987.2007.00468.x.
In June 2003, sevelamer hydrochloride became widely available in Japan and was expected to control hyperphosphatemia in hemodialysis patients without inducing hypercalcemia. To evaluate the impact of sevelamer therapy on mineral metabolism, we recruited 954 hemodialysis patients from 21 renal units just before the general release of sevelamer in Japan. The serum calcium, phosphate, and parathyroid hormone levels determined on enrollment were compared with those later measured in June 2004. Sevelamer was prescribed for 169 of the 859 patients for whom data were available in 2004. The mean calcium level, phosphate level, and calcium x phosphate product were all significantly reduced during the 12-month study period, but the intact parathyroid hormone (iPTH) level did not change. As a result, the percentage of patients who achieved a calcium x phosphate product of <55 mg(2)/dL(2) was significantly increased, but there were no changes in that of patients who achieved the target ranges for phosphate (3.5-5.5 mg/dL) or iPTH (150-300 pg/mL). Among sevelamer-treated patients, iPTH significantly increased, and this change was more marked in the patients with an initial iPTH level <150 pg/mL. Sevelamer was useful for reducing the serum calcium level and calcium x phosphate product, but hyperphosphatemia and hyperparathyroidism were not improved in our study population at 12 months after the release of sevelamer. A decrease in the calcium load might result in the exacerbation of hyperparathyroidism. However, among patients with relative hypoparathyroidism, sevelamer therapy may be beneficial for the prevention of adynamic bone disease.
2003年6月，盐酸司维拉姆在日本广泛上市，有望在不引起高钙血症的情况下控制血液透析患者的高磷血症。为评估司维拉姆治疗对矿物质代谢的影响，在司维拉姆于日本全面上市前，我们从21个肾脏科室招募了954名血液透析患者。将入组时测定的血清钙、磷和甲状旁腺激素水平与2004年6月后来测定的水平进行比较。在2004年有数据的859名患者中，169名患者使用了司维拉姆。在为期12个月的研究期间，平均钙水平、磷水平和钙磷乘积均显著降低，但完整甲状旁腺激素（iPTH）水平未发生变化。结果，钙磷乘积<55mg²/dL²的患者百分比显著增加，但达到磷（3.5 - 5.5mg/dL）或iPTH（150 - 300pg/mL）目标范围的患者百分比没有变化。在接受司维拉姆治疗的患者中，iPTH显著升高，且这种变化在初始iPTH水平<150pg/mL的患者中更为明显。司维拉姆有助于降低血清钙水平和钙磷乘积，但在我们的研究人群中，司维拉姆上市12个月后，高磷血症和甲状旁腺功能亢进并未得到改善。钙负荷的降低可能导致甲状旁腺功能亢进加重。然而，在相对甲状旁腺功能减退的患者中，司维拉姆治疗可能有利于预防动力缺失性骨病。
