Nakayamadera Imai Clinic, Takarazuka, Hyogo, Japan.
Nephrol Dial Transplant. 2013 Oct;28(10):2526-34. doi: 10.1093/ndt/gft249. Epub 2013 Sep 7.
Proteinuria is a major predictor for progression of renal disease, including diabetic nephropathy. In a post hoc analysis of the ORIENT, a double-blinded randomized trial of 566 type 2 diabetic patients with nephropathy, we examined the risk association of composite renal outcome [end-stage renal disease, ESRD, doubling of serum creatinine (SCr) and death] with baseline, change and residual urinary protein/creatinine ratio (UPCR).
We estimated the hazard ratios (HRs) with 95% confidence interval (CI) of composite renal outcome with baseline UPCR (low <1.0 g/gCr; moderate ≥ 1.0 g/gCr, <3.0 g/gCr and high ≥ 3.0 g/gCr) as well as percentage reduction of UPCR (Δ) (worsening: <0%; moderate: ≥ 0%, <30% and high ≥ 30%) and residual UPCR at 24 weeks (remission <1.0 g/gCr; moderate ≥ 1.0 g/gCr, <3.0 g/gCr and heavy ≥ 3.0 g/gCr).
Compared with the low group with baseline UPCR < 1.0 g/gCr, the respective HRs with 95% CI in the moderate and high UPCR groups were 3.02 (1.76-5.19) and 9.24 (5.43-15.73). Compared with patients with a worsening UPCR (<0%) at 24 weeks, the HR was 0.54 (0.39-0.74) in those with ≥ 0%, <30% ΔUPCR and 0.43 (0.31-0.61) in those with ≥ 30% ΔUPCR. Compared with the remission at 24 weeks, the HR was 2.12 (1.28-3.49) in moderate residual proteinuria and 4.59 (2.74-7.69) in heavy residual proteinuria. Compared with patients with residual UPCR ≥ 1.0 g/gCr and ΔUPCR <30%, the HR in those with ΔUPCR ≥ 30% and residual UPCR<1.0 g/gCr was 0.38 (0.22-0.64).
In patients with type 2 diabetes and overt nephropathy, over 30% reduction of UPCR compared with baseline and/or residual UPCR<1.0 g/gCr at 24 weeks predicted renoprotection. These values may be used as targets to guide anti-proteinuric and renoprotective therapy in diabetic nephropathy.
ClinicalTrials.gov NCT00141453.
蛋白尿是肾脏疾病进展的主要预测因素，包括糖尿病肾病。在 ORIENT 的事后分析中，该研究是一项针对 566 例伴有肾病的 2 型糖尿病患者的双盲随机试验，我们检查了复合肾脏结局[终末期肾病（ESRD）、血清肌酐（SCr）加倍和死亡]与基线、变化和残余尿蛋白/肌酐比（UPCR）的风险关联。
我们使用 95%置信区间（CI）估计了复合肾脏结局的风险比（HR），并将基线 UPCR（低值 <1.0 g/gCr；中值≥1.0 g/gCr，<3.0 g/gCr 和高值≥3.0 g/gCr）以及 UPCR （Δ）的百分比降低（恶化：<0%；中值：≥0%，<30%和高值≥30%）和 24 周时的残余 UPCR（缓解<1.0 g/gCr；中值≥1.0 g/gCr，<3.0 g/gCr 和高值≥3.0 g/gCr）作为参考。
与基线 UPCR<1.0 g/gCr 的低值 UPCR 组相比，中值和高值 UPCR 组的相应 HR 分别为 3.02（1.76-5.19）和 9.24（5.43-15.73）。与 24 周时 UPCR 恶化（<0%）的患者相比，UPCR 降低≥0%，<30%（ΔUPCR）和 UPCR 降低≥30%的患者 HR 分别为 0.54（0.39-0.74）和 0.43（0.31-0.61）。与 24 周时缓解相比，中值残余蛋白尿患者的 HR 为 2.12（1.28-3.49），重度残余蛋白尿患者的 HR 为 4.59（2.74-7.69）。与残余 UPCR≥1.0 g/gCr 和ΔUPCR<30%的患者相比，ΔUPCR≥30%和残余 UPCR<1.0 g/gCr 的患者的 HR 为 0.38（0.22-0.64）。
在伴有显性肾病的 2 型糖尿病患者中，与基线相比，UPCR 降低超过 30%，且 24 周时残余 UPCR<1.0 g/gCr 预测肾脏保护作用。这些值可用于指导糖尿病肾病的抗蛋白尿和肾脏保护治疗。
ClinicalTrials.gov NCT00141453。
