Department of Nephrology, San Cecilio University Hospital, Miguel Ruiz del Castillo 4, Granada,
Nefrologia. 2011;31(6):697-706. doi: 10.3265/Nefrologia.pre2011.Aug.11030.
Secondary hyperparathyroidism is a common complication in patients with chronic kidney disease. Treatment with paricalcitol, a selective vitamin D receptor (VDR) activator, has shown benefits in these patients by adequately reducing PTH levels with minimal changes in serum calcium and phosphorus. The aim of this study was to assess the effectiveness and safety of paricalcitol in chronic renal disease patients (CKD grades 3 and 4).
A study of our experience with paricalcitol was conducted in normal clinical practice in patients over 18 years diagnosed with grade 3 or 4 chronic kidney disease. Patients were periodically evaluated every 3 months. The primary endpoint of effectiveness was to obtain two consecutive decreases of ≥30% in iPTH with respect to baseline values. The secondary endpoints were fulfilment of the objectives in accordance with the Spanish Society of Nephrology (SEN) and Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines, as well as the relationship between the effectiveness of the treatment and different patient variables. Safety was studied by means of hypercalcaemia events.
The primary study endpoint was achieved in 54.3% of patients. In addition, another 16.3% of patients had reduced iPTH by more than 30% at the 3rd visit. Therefore, 70.6% of patients reduced their iPTH levels by more than 30% in 6 months. The relationship between treatment success and both glomerular filtration rate and body mass index was significant. There were few adverse events, although hypercalcaemia was found in 5.4% of patients.
Treatment with paricalcitol is effective in controlling secondary hyperparathyroidism in non-dialysed patients with a wide safety margin.
继发性甲状旁腺功能亢进症是慢性肾脏病患者的常见并发症。使用选择性维生素 D 受体（VDR）激活剂帕立骨化醇治疗可通过充分降低 PTH 水平，同时使血清钙和磷的变化最小，从而为这些患者带来益处。本研究旨在评估帕立骨化醇在慢性肾脏病患者（CKD 3 期和 4 期）中的疗效和安全性。
我们在正常临床实践中对帕立骨化醇在年龄大于 18 岁、被诊断为 CKD 3 或 4 期的患者中的使用经验进行了研究。患者定期每 3 个月进行评估。有效性的主要终点是获得相对于基线值连续两次下降≥30%的 iPTH。次要终点是根据西班牙肾脏病学会（SEN）和肾脏病预后质量倡议（K/DOQI）指南达到目标，以及治疗效果与不同患者变量之间的关系。通过高钙血症事件来研究安全性。
54.3%的患者达到了主要研究终点。此外，还有 16.3%的患者在第 3 次就诊时 iPTH 降低了超过 30%。因此，70.6%的患者在 6 个月内 iPTH 水平降低了超过 30%。治疗成功与肾小球滤过率和体重指数之间存在显著关系。虽然有 5.4%的患者出现高钙血症，但不良事件很少。
帕立骨化醇治疗可有效控制未透析的继发性甲状旁腺功能亢进症患者，安全性高。
