Penang Hospital, Georgetown, Malaysia.
Nephrology (Carlton). 2013 Mar;18(3):194-200. doi: 10.1111/nep.12029.
The objective of the study was to compare the efficacy and safety of oral paricalcitol with oral calcitriol for treating secondary hyperparathyroidism.
We conducted the first multicenter open-labelled parallel group randomized controlled trial in 66 patients on dialysis. Patients were randomized to paricalcitol or calcitriol at a 3:1 dose ratio and adjusted to maintain intact parathyroid hormone (iPTH) level between 150-300 pg/mL, serum calcium ≤2.74 mmol/L and calcium-phosphate product ≤5.63 mmol(2) /L(2). The primary end point was the proportion of patients who achieved >30% reduction in iPTH.
At 24 weeks, 22 (61.1%) patients in the paricalcitol and 22 (73.3%) in the calcitriol group had achieved the primary end-point (P-value = 0.29). The cumulative proportion of patients who achieved the end-point at 6 weeks, 12 weeks and 24 weeks were 50%, 80.6% and 86.1%, respectively, in paricalcitol and 53.3%, 86.7% and 86.7%, respectively, in the calcitriol group (P-value = 0.67). Median time to the end-point was 6 weeks in both groups. There were no significant differences in iPTH level at any time during the study. The median reduction in iPTH at 24 weeks was 48.4% in the paricalcitol group and 41.9% in the calcitriol group (P-value = 0.6). The median maximal iPTH reduction was 77.1% (paricalcitol) and 83.7% (calcitriol), P-value = 0.3. Serum calcium and incidence of hypercalcaemia did not differ between groups. 16.7% of patients in both groups had at least one episode of hypercalcaemia (serum calcium >2.74 mmol/L). Other adverse events were similar between groups.
Our study suggests that oral paricalcitol has similar efficacy and safety to oral calcitriol.
本研究旨在比较口服帕立骨化醇与口服骨化三醇治疗继发性甲状旁腺功能亢进症的疗效和安全性。
我们在 66 名透析患者中进行了首次多中心开放性平行组随机对照试验。患者按 3:1 的剂量比随机分配至帕立骨化醇或骨化三醇组，并调整剂量以维持全段甲状旁腺激素（iPTH）水平在 150-300pg/mL 之间、血清钙≤2.74mmol/L 及钙磷乘积≤5.63mmol²/L²。主要终点为 iPTH 降低幅度超过 30%的患者比例。
24 周时，帕立骨化醇组 22 例（61.1%）和骨化三醇组 22 例（73.3%）达到主要终点（P 值=0.29）。6 周、12 周和 24 周时达到终点的患者累积比例分别为帕立骨化醇组 50%、80.6%和 86.1%，骨化三醇组分别为 53.3%、86.7%和 86.7%（P 值=0.67）。两组达到终点的中位时间均为 6 周。研究期间，两组的 iPTH 水平在任何时间均无显著差异。帕立骨化醇组 24 周时 iPTH 降低的中位数为 48.4%，骨化三醇组为 41.9%（P 值=0.6）。最大 iPTH 降低的中位数分别为帕立骨化醇组 77.1%和骨化三醇组 83.7%（P 值=0.3）。两组均有 16.7%的患者至少发生一次高钙血症（血清钙>2.74mmol/L）。两组的其他不良反应相似。
本研究表明，口服帕立骨化醇与口服骨化三醇具有相似的疗效和安全性。
