Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics, Beijing l00020, China (Chen C, Email: chenchaoying484@126. com).
Zhongguo Dang Dai Er Ke Za Zhi. 2022 Aug 15;24(8):853-857. doi: 10.7499/j.issn.1008-8830.2203029.
To study the clinical effect of full-dose prednisone for 4 or 6 weeks in the treatment of children with primary nephrotic syndrome and its effect on recurrence.
A prospective non-randomized controlled clinical trial was performed on 89 children who were hospitalized and diagnosed with incipient primary nephrotic syndrome from December 2017 to May 2019. The children were given prednisone of 2 mg/(kg·day) (maximum 60 mg) for 4 weeks (4-week group) or 6 weeks (6-week group), followed by 2 mg/(kg·day) (maximum 60 mg) every other day for 4 weeks and then a gradual reduction in dose until drug withdrawal. The children were regularly followed up for 1 year. The two groups were compared in terms of the indices including remission maintenance time and recurrence rate. A Cox regression analysis was used to assess the risk factors for recurrence.
Within 3 months after prednisone treatment, the 4-week group had a significantly higher recurrence rate than the 6-week group (<0.05). After 1-year of follow-up, there was no significant difference between the two groups in the recurrence rate, remission maintenance time, and recurrence frequency (>0.05). The risk of recurrence increased in children with an onset age of ≥6 years or increased 24-hour urinary protein (<0.05).
For the treatment of incipient primary nephrotic syndrome, full-dose prednisone regimen extended from 4 weeks to 6 weeks can reduce recurrence within 3 months. The children with an onset age of ≥6 years or a high level of urinary protein should be taken seriously in clinical practice, and full-dose prednisone treatment for 6 weeks is recommended to reduce the risk of recurrence.
研究大剂量泼尼松治疗儿童原发性肾病综合征 4 周与 6 周的临床疗效及其对复发的影响。
采用前瞻性非随机对照临床试验，纳入 2017 年 12 月至 2019 年 5 月在我院住院并诊断为初发原发性肾病综合征的 89 例患儿，给予泼尼松 2mg/（kg·d）（最大 60mg）治疗 4 周（4 周组）或 6 周（6 周组），随后给予 2mg/（kg·d）（最大 60mg）隔日 1 次治疗 4 周，然后逐渐减量直至停药。定期随访 1 年。比较两组患儿的缓解维持时间和复发率等指标。采用 Cox 回归分析评估复发的危险因素。
泼尼松治疗 3 个月内，4 周组的复发率明显高于 6 周组（<0.05）。随访 1 年时，两组患儿的复发率、缓解维持时间、复发次数差异均无统计学意义（>0.05）。起病年龄≥6 岁或 24 小时尿蛋白增加的患儿复发风险增加（<0.05）。
对于初发原发性肾病综合征的治疗，大剂量泼尼松方案由 4 周延长至 6 周可降低治疗 3 个月内的复发风险。起病年龄≥6 岁或尿蛋白水平较高的患儿在临床实践中应予以重视，建议给予大剂量泼尼松治疗 6 周，以降低复发风险。
