Liu Yao-Lung, Lin Hsin-Hung, Yu Chun-Chen, Kuo Huey-Liang, Yang Ya-Fei, Chou Che-Yi, Lin Po-Wen, Liu Jiung-Hsiun, Liao Pen-Yuan, Huang Chiu-Ching
Division of Nephrology, Department of Medicine, China Medical University Hospital, No. 2 Yu-der Road, North District, Taichung City 404, Taiwan.
Ren Fail. 2006;28(8):701-7. doi: 10.1080/08860220600925388.
To evaluate the influence of sevelamer hydrochloride and calcium acetate on biomarkers of bone turnover in patients with hyperphosphatemia receiving hemodialysis.
In this prospective, open-label, randomized, active-controlled study, 70 patients (38 men and 32 women) with hyperphosphatemia (serum phosphorus level >6.0 mg/dL) underwent a two-week washout period and were randomly selected to receive sevelamer hydrochloride (n = 37) or calcium acetate (n = 33) for eight weeks. Changes in serum levels of intact parathyroid hormone (iPTH), alkaline phosphatase (Alk-P), phosphorus, and calcium were measured and compared.
After eight weeks of treatment, calcium acetate lowered iPTH levels significantly more than sevelamer hydrochloride did (-178.0 vs. -69.0 pg/mL, p = 0.0019). Levels of Alk-P were significantly elevated in patients given sevelamer hydrochloride compared with levels in those given calcium acetate treatment (24.09 vs. 7.45 U/L, p = 0.0014). Changes in serum phosphorus levels did not differ between sevelamer hydrochloride (-1.93 mg/dL) and calcium acetate (-2.5 mg/dL) at the end of the study (p = 0.0514). Changes in the calcium and phosphorous product did not significantly differ between the sevelamer-hydrochloride group (-18.06 mg2/dL2) and the calcium-acetate group (-19.05 mg2/dL2, p = 0.6764). Fifteen patients (45.5%) treated with calcium acetate had hypercalcemia (serum-adjusted calcium level >10.5 mg/dL); the rate was significantly higher than that of patients treated with sevelamer (five [13.5%] of 37, p = 0.0039).
Treatment with sevelamer hydrochloride had the advantage of maintaining stable iPTH levels and elevating Alk-P levels while lowering serum phosphorus levels and calcium-phosphorous product.
评估盐酸司维拉姆和醋酸钙对接受血液透析的高磷血症患者骨转换生物标志物的影响。
在这项前瞻性、开放标签、随机、活性对照研究中，70例高磷血症患者（38例男性和32例女性，血清磷水平>6.0mg/dL）经历了为期两周的洗脱期，然后被随机选择接受盐酸司维拉姆（n = 37）或醋酸钙（n = 33）治疗8周。测量并比较血清完整甲状旁腺激素（iPTH）、碱性磷酸酶（Alk-P）、磷和钙水平的变化。
治疗8周后，醋酸钙降低iPTH水平的幅度明显大于盐酸司维拉姆（-178.0对-69.0pg/mL，p = 0.0019）。与接受醋酸钙治疗的患者相比，接受盐酸司维拉姆治疗的患者Alk-P水平显著升高（24.09对7.45U/L，p = 0.0014）。在研究结束时，盐酸司维拉姆组（-1.93mg/dL）和醋酸钙组（-2.5mg/dL）的血清磷水平变化无差异（p = 0.0514）。盐酸司维拉姆组（-18.06mg²/dL²）和醋酸钙组（-19.05mg²/dL²，p = 0.6764）的钙磷乘积变化无显著差异。15例接受醋酸钙治疗的患者（45.5%）出现高钙血症（血清校正钙水平>10.5mg/dL）；该发生率显著高于接受司维拉姆治疗的患者（37例中的5例[13.5%]，p = 0.0039）。
盐酸司维拉姆治疗具有维持iPTH水平稳定、提高Alk-P水平，同时降低血清磷水平和钙磷乘积的优势。
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