Department of Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, California.
Fresenius Medical Care North America, Waltham, Massachusetts; and.
Clin J Am Soc Nephrol. 2020 Mar 6;15(3):384-391. doi: 10.2215/CJN.07960719. Epub 2020 Feb 28.
In the United States, intravenous vitamin D analogs are the first-line therapy for management of secondary hyperparathyroidism in hemodialysis patients. Outside the United States, oral calcitriol (1,25-dihydroxyvitamin D) is routinely used. We examined standard laboratory parameters of patients on in-center hemodialysis receiving intravenous vitamin D who switched to oral calcitriol.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We conducted a retrospective cohort study of adult patients treated within Fresenius Kidney Care clinics. During a 6-month period (December 2013 to May 2014), we identified patients on an intravenous vitamin D analog (doxercalciferol or paricalcitol) who switched to oral calcitriol and matched them to patients receiving an intravenous vitamin D analog. Mean serum calcium, phosphate, and intact parathyroid hormone (iPTH) concentrations were examined for up to 12 months of follow-up. We used Poisson and Cox proportional hazards regression models to examine hospitalization and survival rates. The primary analysis was conducted as intention-to-treat; secondary analyses included an as-treated evaluation.
A total of 2280 patients who switched to oral calcitriol were matched to 2280 patients receiving intravenous vitamin D. Compared with patients on intravenous vitamin D, mean calcium and phosphate levels in the oral calcitriol group were lower after the change to oral calcitriol. In contrast, iPTH levels were higher in the oral calcitriol group. At 12 months, the percentage of patients with composite laboratories in target range (calcium <10 mg/dl, phosphate 3.0-5.5 mg/dl, and iPTH 150-600 pg/ml) were comparable between groups (45% versus 45%; =0.96). Hospital admissions, length of hospital stay, and survival were comparable between groups. An as-treated analysis and excluding those receiving cinacalcet did not reveal significant between-group differences.
Among patients receiving in-center hemodialysis who were switched to oral calcitriol versus those on an intravenous vitamin D analog, the aggregate of all mineral and bone laboratory parameters in range was largely similar between groups.
在美国，静脉内维生素 D 类似物是治疗血液透析患者继发性甲状旁腺功能亢进的一线治疗药物。在美国以外，口服骨化三醇（1,25-二羟维生素 D）常规使用。我们检查了接受静脉内维生素 D 治疗的中心血液透析患者的标准实验室参数，这些患者转为口服骨化三醇。
设计、地点、参与者和测量：我们对 Fresenius Kidney Care 诊所治疗的成年患者进行了回顾性队列研究。在 6 个月期间（2013 年 12 月至 2014 年 5 月），我们确定了正在接受静脉内维生素 D 类似物（ doxercalciferol 或 paricalcitol）治疗的患者转为口服骨化三醇，并将他们与接受静脉内维生素 D 类似物治疗的患者相匹配。在随访的最多 12 个月内，检查了血清钙、磷和全段甲状旁腺激素（iPTH）的浓度。我们使用泊松和 Cox 比例风险回归模型来检查住院率和生存率。主要分析为意向治疗；次要分析包括治疗评估。
共有 2280 名转为口服骨化三醇的患者与 2280 名接受静脉内维生素 D 治疗的患者相匹配。与接受静脉内维生素 D 的患者相比，转为口服骨化三醇后，口服骨化三醇组的平均钙和磷水平较低。相反，口服骨化三醇组的 iPTH 水平较高。在 12 个月时，复合实验室指标在目标范围内的患者百分比（钙<10mg/dl，磷 3.0-5.5mg/dl，iPTH 150-600pg/ml）在两组之间相似（45%对 45%；=0.96）。组间住院率、住院时间和生存率无显著差异。治疗分析和排除使用 cinacalcet 的患者后，两组之间也没有显著差异。
在接受中心血液透析治疗的患者中，与接受静脉内维生素 D 类似物治疗的患者相比，转为口服骨化三醇的患者的所有矿物质和骨实验室参数总体上在目标范围内相似。
