Mantan Mukta, Kansal Aparajita, Swarnim Swarnim
Department of Pediatrics, Maulana Azad Medical College and Associated Lok Nayak Hospital, University of Delhi, New Delhi, India.
Indian J Nephrol. 2022 Nov-Dec;32(6):588-594. doi: 10.4103/ijn.ijn_463_21. Epub 2022 Jul 16.
There may be a role of reducing the total steroid doses for the treatment of relapses of nephrotic syndrome in children with milder and more stable disease. The primary objective of this study was to compare the effectiveness of a low-dose prednisolone regimen with standard therapy for the treatment of relapses in steroid-sensitive nephrotic syndrome (SSNS) at the end of treatment, the secondary objectives being time to remission and sustained remission after 3 months.
This randomized controlled trial included a total of 40 children (20 in each group) with SSNS (presently infrequently relapsing course) and with a relapse. Both groups received prednisolone at a dose of 2 mg/kg/day until remission; subsequently, the patients in the study group received 1 mg/kg, and the control group participants received 1.5 mg/kg prednisolone on alternate days for 4 weeks. The patients were followed up till 3 months after stopping the therapy.
The median (IQR) age of children enrolled was 7.5 (range: 5-9.65) years, and the age at onset of nephrotic syndrome was 4 (range: 2.3-5.5) years. The median time to achieve remission was 9 days (comparable in low dose vs. standard therapy group; = 0.14). All patients were in remission at the end of therapy; 85% of patients were in the low-dose group and 90% in the standard therapy group after 1 month ( = 0.32). At the end of 3 months, 60% continued to be in remission in the low-dose group and 65% with standard therapy ( = 0.37). Hazard ratios for relapse at the end of 1, 2, and 3 months were 1.05, 1.08, and 1.13, respectively. Patients who were infrequently relapsing (79%) from the onset of nephrotic syndrome had higher remission rates at the end of 3 months (80% in the low-dose group vs. 76.9% in the standard therapy group). Hazard ratios for relapse in these patients at the end of 1, 2, and 3 months were 1.01, 1.03, and 1.08, respectively.
Lower doses of prednisolone can be used for the treatment of relapse of steroid sensitive nephrotic syndrome, with an infrequently relapsing course.
对于病情较轻且更稳定的儿童肾病综合征复发的治疗，减少类固醇总剂量可能会起到一定作用。本研究的主要目的是比较低剂量泼尼松龙方案与标准疗法在治疗类固醇敏感性肾病综合征（SSNS）复发时治疗结束时的有效性，次要目标是缓解时间以及3个月后的持续缓解情况。
这项随机对照试验共纳入40名患有SSNS（目前复发频率较低病程）且复发的儿童（每组20名）。两组均接受2mg/kg/天的泼尼松龙治疗直至缓解；随后，研究组患者接受1mg/kg，对照组参与者隔天接受1.5mg/kg泼尼松龙治疗，共4周。对患者随访至停药后3个月。
入组儿童的中位（IQR）年龄为7.5岁（范围：5 - 9.65岁），肾病综合征发病年龄为4岁（范围：2.3 - 5.5岁）。达到缓解的中位时间为9天（低剂量组与标准治疗组相当；P = 0.14）。治疗结束时所有患者均缓解；1个月后，低剂量组85%的患者缓解，标准治疗组为90%（P = 0.32）。3个月末，低剂量组60%的患者持续缓解，标准治疗组为65%（P = 0.37）。1、2和3个月末复发的风险比分别为1.05、1.08和1.13。从肾病综合征起病就复发频率较低的患者（79%）在3个月末有更高的缓解率（低剂量组80% vs. 标准治疗组76.9%）。这些患者在1、2和3个月末复发的风险比分别为1.01、1.03和1.08。
较低剂量的泼尼松龙可用于治疗复发频率较低病程的类固醇敏感性肾病综合征复发。
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