目的 探讨足量泼尼松应用4周与6周方案治疗初发原发性肾病综合征患儿的疗效及对缓解后复发的影响。 方法 采用非随机对照临床研究法，前瞻性纳入2017年12月至2019年5月住院并诊断为初发原发性肾病综合征的89例患儿为研究对象，分别予泼尼松2 mg/(kg·d)（最多60 mg）应用4周（4周组）或6周（6周组）治疗。之后均改为2 mg/kg（最多60 mg）隔日应用4周，之后逐渐减停。定期随访1年。比较两组维持缓解时间、复发率等指标，并采用Cox回归分析复发的危险因素。 结果 泼尼松治疗后3个月内4周组复发率高于6周组（P<0.05）；随访1年时，两组复发率、维持缓解时间及复发频率的比较差异无统计学意义（P>0.05）。起病年龄≥6岁及24 h尿蛋白定量升高是复发的危险因素（P<0.05）。 结论 足量泼尼松治疗初发原发性肾病综合征的方案由4周延至6周可减少患儿前3个月内的复发。临床上应高度关注起病年龄≥6岁和高水平尿蛋白量患儿，建议给予足量泼尼松治疗6周以降低复发风险。
Abstract
Objective 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. Methods 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. Results Within 3 months after prednisone treatment, the 4-week group had a significantly higher recurrence rate than the 6-week group (P<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 (P>0.05). The risk of recurrence increased in children with an onset age of ≥6 years or increased 24-hour urinary protein (P<0.05). Conclusions 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.
关键词
原发性肾病综合征 /
泼尼松 /
复发 /
儿童
Key words
Primary nephrotic syndrome /
Prednisone /
Recurrence /
Child
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参考文献
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