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霉酚酸酯与环磷酰胺治疗儿童肾病范围蛋白尿型过敏性紫癜性肾炎的疗效与安全性:一项前瞻性随机对照试验

[Efficacy and safety of mycophenolate mofetil versus cyclophosphamide in the treatment of Henoch-Schönlein purpura nephritis with nephrotic-range proteinuria in children: a prospective randomized controlled trial].

作者信息

Geng Hai-Yun, Chen Chao-Ying, Li Hua-Rong, Tu Juan, DU Pei-Wei, Xia Hua

机构信息

Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics, Beijing 100020, China.

出版信息

Zhongguo Dang Dai Er Ke Za Zhi. 2021 Apr;23(4):338-342. doi: 10.7499/j.issn.1008-8830.2012145.

Abstract

OBJECTIVE

To study the efficacy and safety of mycophenolate mofetil (MMF) versus cyclophosphamide (CTX) in the treatment of children with Henoch-Schönlein purpura nephritis (HSPN) and nephrotic-range proteinuria.

METHODS

A prospective clinical trial was conducted in 68 pediatric patients who were admitted to the Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics and who were diagnosed with HSPN and nephrotic-range proteinuria from August 2016 to November 2019. The patients were randomly divided into two groups:MMF treatment (=33) and CTX treatment (=35). The two groups were compared in terms of complete remission rate, response rate (complete remission + partial remission), urinary protein clearance time, and adverse events.

RESULTS

At months 3, 6, and 12 of treatment, there was no significant difference in the complete remission rate and the response rate between the MMF treament and CTX treatment groups ( > 0.05). There was also no significant difference between the two groups in the urinary protein clearance time and the incidence rate of adverse events ( > 0.05).

CONCLUSIONS

MMF and CTX have similar efficacy and safety in the treatment of HSPN children with nephrotic-range proteinuria.

摘要

目的

研究霉酚酸酯(MMF)与环磷酰胺(CTX)治疗小儿紫癜性肾炎(HSPN)并肾病范围蛋白尿的疗效及安全性。

方法

对2016年8月至2019年11月首都儿科研究所附属儿童医院肾病科收治的68例诊断为HSPN并肾病范围蛋白尿的儿科患者进行前瞻性临床试验。将患者随机分为两组:MMF治疗组(n = 33)和CTX治疗组(n = 35)。比较两组的完全缓解率、有效率(完全缓解+部分缓解)、尿蛋白清除时间及不良事件。

结果

治疗3个月、6个月和12个月时,MMF治疗组与CTX治疗组的完全缓解率和有效率比较,差异无统计学意义(P>0.05)。两组尿蛋白清除时间及不良事件发生率比较,差异亦无统计学意义(P>0.05)。

结论

MMF与CTX治疗小儿HSPN并肾病范围蛋白尿的疗效及安全性相似。

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