Dheerendra P C, Sakhuja V, Kohli H S, Jha V
Department of Nephrology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Indian J Nephrol. 2013 Jul;23(4):271-5. doi: 10.4103/0971-4065.114492.
This study was carried out to evaluate the efficacy and safety of doxercalciferol as therapy for secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stage 4 in a prospective clinical trial. A total of 35 CKD-4 patients who had a baseline parathyroid hormone (iPTH) >150 pg/mL and had not received any vitamin D analog in the preceding 8 weeks were followed up at intervals of 6 weeks for 18 weeks on oral therapy with doxercalciferol. The starting dose was 1.5 μg/day, and the dose was increased in steps of 1 μg/day if iPTH did not decrease by at least 30% on the subsequent visit. Doxercalciferol was stopped temporarily if low iPTH (<70 pg/mL), hypercalcemia (>10.7 mg/dL), or severe hyperphosphatemia (>8.0 mg/dL) occurred, and was restarted at a lower dose on reversal of these abnormalities. Calcium acetate was the only phosphate binder used. Mean iPTH decreased by 35.4 ± 4.4% from 381.7 ± 31.3 pg/mL to 237.9 ± 25.7 pg/mL (P < 0.001). The proportion of patients who achieved 30% and 50% suppression of iPTH levels was 83% and 72%, respectively. Mean serum calcium, phosphorus, and calcium-phosphorus product values did not differ significantly from the baseline values. Four, two, and nine patients developed hypercalcemia, severe hyperphosphatemia, and high CaxP (>55), respectively. Almost all patients recovered to an acceptable level within 2 weeks of stopping doxercalciferol and adjusting the phosphate binder dose. In all, 21 patients required temporary stoppage of therapy. Most of them were restarted on therapy at a reduced dose during the study. It can, therefore, be concluded that doxercalciferol is effective in controlling SHPT in CKD-4 patients with an acceptable risk of hyperphosphatemia and hypercalcemia.
本研究旨在通过一项前瞻性临床试验，评估多西骨化醇治疗4期慢性肾脏病（CKD）患者继发性甲状旁腺功能亢进（SHPT）的疗效和安全性。共有35例4期CKD患者，其基线甲状旁腺激素（iPTH）>150 pg/mL，且在之前8周内未接受任何维生素D类似物治疗，接受多西骨化醇口服治疗，每6周随访一次，共随访18周。起始剂量为1.5μg/天，如果下次就诊时iPTH未降低至少30%，则剂量以1μg/天的幅度递增。如果出现低iPTH（<70 pg/mL）、高钙血症（>10.7 mg/dL）或严重高磷血症（>8.0 mg/dL），则暂时停用多西骨化醇，待这些异常情况逆转后，以较低剂量重新开始用药。醋酸钙是唯一使用的磷结合剂。iPTH均值从381.7±31.3 pg/mL降至237.9±25.7 pg/mL，降幅为35.4±4.4%（P<0.001）。iPTH水平抑制30%和50%的患者比例分别为83%和72%。血清钙、磷及钙磷乘积均值与基线值相比无显著差异。分别有4例、2例和9例患者出现高钙血症、严重高磷血症和高钙磷乘积（>55）。几乎所有患者在停用多西骨化醇并调整磷结合剂剂量后2周内恢复到可接受水平。共有21例患者需要暂时停药。他们中的大多数在研究期间以较低剂量重新开始治疗。因此，可以得出结论，多西骨化醇在控制4期CKD患者的SHPT方面有效，且高磷血症和高钙血症风险可接受。
