Department of Nephrology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
Department of Nephrology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
Clin Ther. 2021 May;43(5):859-870. doi: 10.1016/j.clinthera.2021.03.009. Epub 2021 Apr 15.
This study assessed the long-term (10-year) tolerability and efficacy of a low-dose corticosteroid combined with mycophenolate mofetil (CS + MMF) in the treatment of immunoglobulin A nephropathy (IgAN) with stage 3/4 chronic kidney disease and proteinuria in clinical practice in China.
Data from patients with biopsy-proven IgAN, stage 3/4 chronic kidney disease (estimated glomerular filtration rate 15-59 mL/min/1.73 m), and proteinuria (urinary protein excretion ≥1.0 g/d) and who were treated with uncontrolled supportive care (USC), CS, or CS + MMF between January 2008 and December 2017 were included. The primary end point was the prevalence of the composite outcome of any of the following conditions: a reduction in estimated glomerular filtration rate of ≥50%, end-stage renal disease, and death.
Of the 120 enrolled patients, 44, 25, and 51 were treated with USC, CS, and CS + MMF, respectively. The median follow-up time was 40.1 months (IQR, 29.1-67.8 months). The prevalences of the composite outcome were 63.6%, 56.0%, and 19.6%, respectively (P < 0.001). The cumulative 5-year renal function-preservation rates were 48.1%, 51.4%, and 83.7%. After adjustment for covariates, the prevalence of the composite outcome was significantly decreased with CS + MMF (HR = 0.094; 95% CI, 0.026-0.335; P < 0.001), but not with CS (HR = 0.749; 95% CI, 0.354-1.583; P = 0.449), compared with USC. However, 4 patients in the CS + MMF group died, of whom 3 had severe pneumonia.
CS + MMF may have more promising efficacy than USC or CS in renal-function preservation in patients with IgAN and chronic kidney disease in the Chinese population. However, attention should be paid to the increased risk for death due to severe pneumonia.
本研究评估了在中国临床实践中，低剂量皮质类固醇联合吗替麦考酚酯（CS+MMF）治疗伴有 3/4 期慢性肾脏病和蛋白尿的免疫球蛋白 A 肾病（IgAN）患者的长期（10 年）耐受性和疗效，这些患者的蛋白尿为 1.0g/d 以上。
本研究纳入了 2008 年 1 月至 2017 年 12 月期间接受未控制的支持性治疗（USC）、CS 或 CS+MMF 治疗的经活检证实的 IgAN、3/4 期慢性肾脏病（估计肾小球滤过率 15-59ml/min/1.73m2）和蛋白尿（尿蛋白排泄量≥1.0g/d）患者。主要终点是以下任何一种情况的复合结果的发生率：肾小球滤过率下降≥50%、终末期肾病和死亡。
在纳入的 120 名患者中，分别有 44、25 和 51 名患者接受 USC、CS 和 CS+MMF 治疗。中位随访时间为 40.1 个月（IQR，29.1-67.8 个月）。复合结果的发生率分别为 63.6%、56.0%和 19.6%（P<0.001）。5 年的累积肾功能保留率分别为 48.1%、51.4%和 83.7%。调整协变量后，CS+MMF 组的复合结果发生率显著降低（HR=0.094；95%CI，0.026-0.335；P<0.001），而 CS 组则无显著降低（HR=0.749；95%CI，0.354-1.583；P=0.449）。然而，CS+MMF 组有 4 例患者死亡，其中 3 例死于重症肺炎。
CS+MMF 可能比 USC 或 CS 更能在中国 IgAN 合并慢性肾脏病患者中实现肾功能保护，但应注意因重症肺炎导致死亡风险增加。
