Zhang Dongliang, Li He, Yin Daoxin, Wang LiYan, Ma Yao
Department of Nephrology, Peking University International Hospital, No.1 Life Park Road, Zhongguancun Life Park, Changping District, Beijing, PR China.
Faculty of Nephrology, Capital Medical University, PR China; Department of Nephrology, Beijing Friendship Hospital of Capital Medical University, PR China.
Eur J Pharmacol. 2016 Oct 15;789:127-133. doi: 10.1016/j.ejphar.2016.07.019. Epub 2016 Jul 9.
To compare the efficacy and safety of ergocalciferol and calcitriol in stage 3 to 5 chronic kidney disease (CKD) patients, a randomized, prospective, controlled, open-labeled study was designed. 204 patients were enrolled into the present study with following-up duration of 33.2±3.8 months. Patients in Group VitD2 (n=104) and Group aVitD3 (n=100) were treated by ergocalciferol and calcitriol, respectively. The 25-hydroxyvitamin D levels of group VitD2 increased significantly from 15.14±7.46 to 37.32±10.49ng/ml (P<0.001, t=-19.692) and increased more (P<0.001, t=-14.982) than those of group aVitD3, which increased from 14.90±6.15 to 18.08±7.55ng/ml. Maintenance target levels of serum calcium, phosphorus, and intact parathyroid hormone as the primary outcome measure did not show significant difference in frequencies between two groups. In summary, treatment of CKD-mineral and bone disorders in CKD patients at stages 3 to 5 using ergocalciferol has a similar long-term efficacy and safety profile as calcitriol.
为比较骨化醇和骨化三醇对3至5期慢性肾脏病（CKD）患者的疗效和安全性，设计了一项随机、前瞻性、对照、开放标签研究。204例患者纳入本研究，随访时间为33.2±3.8个月。维生素D2组（n = 104）和阿法骨化醇组（n = 100）患者分别接受骨化醇和骨化三醇治疗。维生素D2组的25-羟维生素D水平从15.14±7.46显著升至37.32±10.49ng/ml（P<0.001，t = -19.692），且升高幅度大于阿法骨化醇组（P<0.001，t = -14.982），后者从14.90±6.15升至18.08±7.55ng/ml。作为主要结局指标的血清钙、磷和完整甲状旁腺激素的维持目标水平在两组间的频率上未显示出显著差异。总之，对3至5期CKD患者使用骨化醇治疗CKD-矿物质和骨异常的长期疗效和安全性与骨化三醇相似。
