Renal Division, Fundación Instituto de Investigación Sanitaria Fundación Jiménez Díaz (FIIS-FJD), Avenida Reyes Católicos 2, 29040, Madrid, Spain.
Biostatistics and Epidemiology Unit, Fundación Instituto de Investigación Sanitaria Fundación Jiménez Díaz (FIIS-FJD), 29040, Madrid, Spain.
Nutrients. 2019 Apr 26;11(5):959. doi: 10.3390/nu11050959.
Epidemiological studies have suggested a survival benefit for hemodialysis patients on paricalcitol or calcitriol, but nutritional vitamin D supplementation of patients already on vitamin D receptor (VDR) activators is controversial.
This observational retrospective cohort study was conducted with prospectively collected data from all consecutive patients with chronic kidney disease (CKD) who underwent hemodialysis under routine clinical practice conditions for two years.
Of the 129 patients, 89 were treated with calcidiol, paricalcitol, and/or calcitriol. The patients with any vitamin D formulation had higher serum concentrations of 25-hydroxy vitamin D and fibroblast growth factor-23 and tended to have higher mortality rates (42% 25%, = 0.07). On subgroup analysis, any calcidiol treatment or calcidiol combined with paricalcitol associated with significantly higher mortality rates than no treatment (47% and 62.5%, = 0.043 and 0.008, respectively). The association between calcidiol/paricalcitol treatment and elevated mortality remained significant after adjusting for age, sex, diabetes, C-reactive protein, and hemodialysis vintage. Any calcidiol and calcidiol/paricalcitol treatment exhibited a dose-response relationship with mortality ( for trend: 0.002 and 0.005, respectively).
These data draw attention to the hitherto unexplored safety of calcidiol supplementation in patients on hemodialysis, especially in those already on vitamin D. Until clinical trials demonstrate the safety and efficacy of this approach, caution should be exercised when prescribing these patients ≥0.5 calcidiol mg/month.
流行病学研究表明，帕立骨化醇或骨化三醇治疗的血液透析患者具有生存获益，但对于已经使用维生素 D 受体（VDR）激动剂的患者进行营养性维生素 D 补充存在争议。
本观察性回顾性队列研究采用前瞻性收集数据，纳入了在常规临床实践条件下接受血液透析治疗且连续随访两年的慢性肾脏病（CKD）患者。
129 例患者中，89 例接受骨化二醇、帕立骨化醇和/或骨化三醇治疗。使用任何维生素 D 制剂的患者血清 25-羟维生素 D 和成纤维细胞生长因子 23 浓度更高，且死亡率更高（42%比 25%，=0.07）。亚组分析显示，任何骨化二醇治疗或骨化二醇联合帕立骨化醇治疗与无治疗相比，死亡率显著升高（47%和 62.5%，=0.043 和 0.008）。在调整年龄、性别、糖尿病、C 反应蛋白和血液透析龄后，骨化二醇/帕立骨化醇治疗与死亡率升高的相关性仍然显著。任何骨化二醇和骨化二醇/帕立骨化醇治疗与死亡率均呈剂量反应关系（趋势检验：0.002 和 0.005）。
这些数据提示我们，在血液透析患者中补充骨化二醇的安全性尚待探索，特别是在已经使用维生素 D 的患者中。在临床试验证明这种方法的安全性和疗效之前，对于这些患者，应谨慎处方每月≥0.5 毫克的骨化二醇。
