中等剂量糖皮质激素治疗激素敏感肾病综合征复发患儿的前瞻性随机对照研究

Clinical assessment of moderate-dose glucocorticoid in the treatment of recurrence of primary nephrotic syndrome in children: a prospective randomized controlled trial

摘要:

目的 比较不同剂量糖皮质激素（glucocorticoid，GC）治疗激素敏感肾病综合征（steroid sensitive nephrotic syndrome，SSNS）复发患儿的有效性及药物不良反应。 方法 选取2017年11月至2019年12月在首都儿科研究所附属儿童医院肾脏内科住院并诊断为SSNS复发的患儿67例为研究对象，随机分为中量GC组（n=32）和足量GC组（n=35）。比较两组患儿尿蛋白转阴、6个月内复发和激素不良反应发生情况。 结果 中量GC组尿蛋白转阴率为91%，足量GC组为94%，两组比较差异无统计学意义（P>0.05）。6个月内中量GC组复发率为41%，足量GC组为36%，差异无统计学意义（P>0.05）。随访6个月时，中量GC组患儿泼尼松累积量为（87±18）mg/kg，显著低于足量GC组患儿［（98±16）mg/kg］（P=0.039）；中量GC组6%患儿出现体重异常增加，显著低于足量GC组（33%）（P=0.045）。logistic回归分析显示，入组复发时泼尼松剂量≥10 mg/隔日，是随访6个月内SSNS患儿复发的危险因素（P=0.018）。 结论 对于SSNS复发患儿，应用中剂量GC治疗方案，其6个月内诱导缓解、复发情况较足量GC治疗方案无显著差异，而6个月内GC累积剂量和不良反应较小。

Abstract:

Objective To study the clinical effect and adverse drug reactions of different doses of glucocorticoid (GC) in the treatment of children with recurrence of steroid-sensitive nephrotic syndrome (SSNS). Methods A total of 67 children who were hospitalized and diagnosed with SSNS recurrence in the Department of Nephrology, Children's Hospital, Capital Institute of Pediatrics, from November 2017 to December 2019 were enrolled. They were randomly divided into a moderate-dose GC group (32 children) and a full-dose GC group (35 children). The two groups were compared in terms of urinary protein clearance, recurrence rate within 6 months, and incidence rate of GC-associated adverse reactions. Results There was no significant difference in the urinary protein clearance rate between the moderate-dose GC and full-dose GC groups (91% vs 94%, P>0.05). There was also no significant difference in the recurrence rate within 6 months between the two groups (41% vs 36%, P>0.05). At 6 months of follow-up, compared with the full-dose GC group, the moderate-dose GC group had a significantly lower cumulative dose of prednisone [(87±18) mg/kg vs (98±16) mg/kg, P=0.039] and a significantly lower proportion of children with an abnormal increase in body weight (6% vs 33%, P=0.045). The logistic regression analysis showed that prednisone dose ≥10 mg/alternate day at enrollment was a risk factor for recurrence within 6 months in children with SSNS (P=0.018). Conclusions For children with SSNS recurrence, moderate-dose GC has similar effects to full-dose GC in the remission induction rate and the recurrence rate within 6 months, with a lower cumulative dose and fewer GC-associated adverse reactions within 6 months than full-dose GC. Citation:Chinese Journal of Contemporary Pediatrics, 2022, 24(5): 466-471