口服骨化三醇减少 IgA 肾病患者蛋白尿：一项随机对照试验。
Oral calcitriol for reduction of proteinuria in patients with IgA nephropathy: a randomized controlled trial.
机构信息
Renal Division, Peking University First Hospital, Institute of Nephrology, Peking University, Key Laboratory of Renal Disease, Ministry of Health of China, Beijing, PR China.
出版信息
Am J Kidney Dis. 2012 Jan;59(1):67-74. doi: 10.1053/j.ajkd.2011.09.014. Epub 2011 Oct 22.
BACKGROUND
Vitamin D has shown efficacy in the reduction of proteinuria in patients with chronic kidney disease. This study aimed to determine the effect of calcitriol on urinary protein excretion in patients with immunoglobulin A (IgA) nephropathy.
STUDY DESIGN
Open-label, non-placebo-controlled, randomized study.
SETTING & PARTICIPANTS: 50 patients with IgA nephropathy were enrolled. The main criterion for inclusion was urinary protein excretion >0.8 g/d after renin-angiotensin system-inhibitor treatment for at least 3 months.
INTERVENTION
Patients were randomly assigned (1:1) to receive 2 doses (0.5 μg) of calcitriol per week or no treatment for 48 weeks.
OUTCOMES
The primary end point was to compare change in 24-hour urinary protein excretion from baseline to last measurement during treatment.
MEASUREMENTS
Every 8 weeks, there was measurement of 24-hour urinary protein excretion, serum calcium, serum phosphorus, serum creatinine, and intact parathyroid hormone.
RESULTS
Measurement of the primary end point showed changes in urinary protein excretion of +21% (from 1.29 to 1.58 g/24 h; 95% CI, -9% to +52%) in the control group and -19% (from 1.60 to 1.30 g/24 h; 95% CI, -42% to +4%) in the calcitriol-treated group. There was a significant decrease in proteinuria in the calcitriol-treated group compared with the control group (difference between groups, 41%; 95% CI, 5%-79%; P = 0.03). The secondary end point of achieving at least a 15% decrease in proteinuria was attained by 7 of 24 (29%) controls and 17 of 26 (65%) of those treated with calcitriol (P = 0.02). No significant differences were observed in decrease in estimated glomerular filtration rate and change in blood pressure between the 2 groups. The incidence of recorded adverse events was similar between the 2 groups.
LIMITATIONS
Small and non-placebo-controlled study.
CONCLUSIONS
The addition of calcitriol to a renin-angiotensin system inhibitor resulted in a safe decrease in proteinuria in patients with IgA nephropathy.
背景
维生素 D 已被证明可有效减少慢性肾脏病患者的蛋白尿。本研究旨在确定骨化三醇对 IgA 肾病患者尿蛋白排泄的影响。
研究设计
开放标签、非安慰剂对照、随机研究。
研究地点和参与者
纳入 50 例 IgA 肾病患者。主要纳入标准为肾素-血管紧张素系统抑制剂治疗至少 3 个月后，尿蛋白排泄量>0.8 g/d。
干预措施
患者被随机分为（1:1）每周接受 2 次（0.5 μg）骨化三醇或 48 周不治疗。
主要终点
比较治疗期间从基线到最后一次测量时 24 小时尿蛋白排泄量的变化。
测量
每 8 周测量 24 小时尿蛋白排泄量、血清钙、血清磷、血清肌酐和全段甲状旁腺激素。
结果
主要终点的测量显示，对照组尿蛋白排泄量增加 21%（从 1.29 增加到 1.58 g/24 h；95%CI，-9%至+52%），而骨化三醇治疗组下降 19%（从 1.60 减少到 1.30 g/24 h；95%CI，-42%至+4%）。与对照组相比，骨化三醇治疗组的蛋白尿明显减少（组间差异，41%；95%CI，5%-79%；P=0.03）。达到至少 15%尿蛋白减少的次要终点的患者在对照组中为 7 例（29%），在接受骨化三醇治疗的患者中为 17 例（65%）（P=0.02）。两组间估计肾小球滤过率的下降和血压的变化无显著差异。两组记录的不良事件发生率相似。
局限性
样本量小且非安慰剂对照研究。
结论
在肾素-血管紧张素系统抑制剂的基础上加用骨化三醇可安全降低 IgA 肾病患者的蛋白尿。
Zotero 插件