Huang Jianni, Lin Li, Xie Jingyuan, Li Xiao, Shen Pingyan, Pan Xiaoxia, Ren Hong, Chen Nan
Department of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, China.
Clin Exp Nephrol. 2018 Dec;22(6):1315-1323. doi: 10.1007/s10157-018-1585-z. Epub 2018 May 14.
To compare the efficacy of glucocorticoids in primary focal segmental glomerulosclerosis (pFSGS) patients with moderate proteinuria. Registered at http://www.chictr.org.cn/ , study No. ChiCTR-OPN-17012789.
pFSGS patients with urine protein between 1.0 and 3.5 g/24 h were recruited from 2006 to 2016. No decline in urine protein > 50% was observed after 2 months of run-in angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (ACEI/ARB) treatment. Patients were assigned to study group (glucocorticoids with ACEI/ARB) or control group (ACEI/ARB without glucocorticoids). Variables including 24-h urinary protein, serum albumin and serum creatinine during the trial were recorded. Remission was defined as proteinuria < 0.3 g/24 h or declined > 50%, and our composite end point as > 30% decrease of eGFR or eGFR < 30 ml/min.
A total of 102 patients were enrolled (study group N = 52, control group N = 50), and the median follow-up time was 36 (12-117) months without significant difference between groups. During the 12-month follow-up, the remission rate was significantly higher in study group [73.1 vs 50.0% (P = 0.01)], and the initial median response time was 3 months in the study group while 6 in the control group. The end point was reached by 22.2% cases in study group, and 42.0% in control. The medium survival times were study group 72 months and control 57 (P = 0.03). Minor adverse reactions were observed in 10 patients (study group N = 8, control group N = 2).
Additional glucocorticoids therapy is more efficacious compared to ACEI/ARB alone in the treatment of patients with pFSGS and moderate proteinuria.
比较糖皮质激素对中度蛋白尿的原发性局灶节段性肾小球硬化（pFSGS）患者的疗效。注册于http://www.chictr.org.cn/，研究编号ChiCTR-OPN-17012789。
招募2006年至2016年期间尿蛋白在1.0至3.5 g/24小时之间的pFSGS患者。在进行2个月的血管紧张素转换酶抑制剂/血管紧张素受体阻滞剂（ACEI/ARB）治疗后，未观察到尿蛋白下降超过50%。患者被分配到研究组（糖皮质激素联合ACEI/ARB）或对照组（不使用糖皮质激素的ACEI/ARB）。记录试验期间包括24小时尿蛋白、血清白蛋白和血清肌酐在内的变量。缓解定义为蛋白尿<0.3 g/24小时或下降超过50%，我们的复合终点为eGFR下降>30%或eGFR<30 ml/min。
共纳入102例患者（研究组N = 52，对照组N = 50），中位随访时间为36（12 - 117）个月，两组间无显著差异。在12个月的随访期间，研究组的缓解率显著更高[73.1%对50.0%（P = 0.01）]，研究组的初始中位反应时间为3个月，而对照组为6个月。研究组22.2%的病例达到终点，对照组为42.0%。中位生存时间研究组为72个月，对照组为57个月（P = 0.03）。10例患者出现轻微不良反应（研究组N = 8，对照组N = 2）。
在治疗pFSGS和中度蛋白尿患者时，额外的糖皮质激素治疗比单独使用ACEI/ARB更有效。
