Kidney Disease Center, The First Affiliated Hospital, Medical School of Zhejiang University, Hangzhou, China.
Clin J Am Soc Nephrol. 2012 Mar;7(3):391-400. doi: 10.2215/CJN.03000311. Epub 2012 Jan 5.
Observational data indicate that newer vitamin D compounds such as paricalcitol can suppress serum intact parathyroid hormone (iPTH) and reduce proteinuria in patients with CKD. To systematically evaluate the efficacy and safety of paricalcitol for CKD, we conducted a meta-analysis of the published randomized controlled trials (RCTs).
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: MEDLINE, Embase, the Cochrane Library, and article reference lists were searched for RCTs that compared paricalcitol with placebo in the treatment of patients with stage 2-5 CKD. The quality of the studies was evaluated using the Jadad method. The results are summarized as risk ratios (RRs) for dichotomous outcomes or mean differences for continuous outcomes.
Nine studies (832 patients) were included. Compared with placebo, paricalcitol suppressed serum iPTH (RR, 6.37; 95% confidence interval [95% CI], 4.64-8.74; P<0.001) and reduced proteinuria (RR, 1.68; 95% CI, 1.25-2.25; P<0.001). Compared with the control group, the RR for hypercalcemia associated with paricalcitol use was 2.25 (95% CI, 0.81-6.26; P=0.12). Patients receiving paricalcitol therapy did not have an increased risk of endocrine system and cardiovascular system adverse effects (RR, 1.07; 95% CI, 0.84-1.36; P=0.58).
We confirm that paricalcitol suppresses iPTH and lowers proteinuria in patients with stage 2-5 CKD without an increased risk of adverse events. A trend toward increased hypercalcemia did not reach statistical significance, but may be clinically relevant. A randomized trial is needed to determine if paricalcitol affects the development of ESRD or mortality.
观察性数据表明，新型维生素 D 化合物如帕立骨化醇可抑制血清全段甲状旁腺激素（iPTH）并减少 CKD 患者的蛋白尿。为了系统评估帕立骨化醇治疗 CKD 的疗效和安全性，我们对已发表的随机对照试验（RCT）进行了荟萃分析。
设计、设置、参与者和测量：检索 MEDLINE、Embase、Cochrane 图书馆和文章参考文献列表，以查找比较帕立骨化醇与安慰剂治疗 2-5 期 CKD 患者的 RCT。使用 Jadad 方法评估研究质量。结果以二分类结局的风险比（RR）或连续结局的均数差表示。
纳入 9 项研究（832 例患者）。与安慰剂相比，帕立骨化醇抑制血清 iPTH（RR，6.37；95%置信区间[95%CI]，4.64-8.74；P<0.001）和减少蛋白尿（RR，1.68；95%CI，1.25-2.25；P<0.001）。与对照组相比，帕立骨化醇相关高钙血症的 RR 为 2.25（95%CI，0.81-6.26；P=0.12）。接受帕立骨化醇治疗的患者发生内分泌和心血管系统不良事件的风险无增加（RR，1.07；95%CI，0.84-1.36；P=0.58）。
我们证实帕立骨化醇可抑制 2-5 期 CKD 患者的 iPTH 并降低蛋白尿，且不增加不良事件风险。高钙血症风险增加的趋势虽未达到统计学意义，但可能具有临床意义。需要进行随机试验来确定帕立骨化醇是否会影响 ESRD 或死亡率的发生。
