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Randomized Controlled Trial
. 2021 Apr;23(4):338-342.
doi: 10.7499/j.issn.1008-8830.2012145.

[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]

[Article in Chinese]
Hai-Yun Geng  1 , Chao-Ying Chen  1 , Hua-Rong Li  1 , Juan Tu  1 , Pei-Wei DU  1 , Hua Xia  1
Affiliations
Randomized Controlled Trial

[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]

[Article in Chinese]
Hai-Yun Geng et al. Zhongguo Dang Dai Er Ke Za Zhi. 2021 Apr.

Abstract
in English, Chinese

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 (n=33) and CTX treatment (n=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 (P > 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 (P > 0.05).

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

目的: 探讨霉酚酸酯（MMF）和环磷酰胺（CTX）分别治疗具有大量蛋白尿[24 h尿蛋白定量≥50 mg/kg或晨尿蛋白/肌酐（mg/mg）≥2.0]的过敏性紫癜性肾炎（HSPN）患儿的疗效和安全性。

方法: 前瞻性纳入2016年8月至2019年11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有大量蛋白尿的HSPN患儿68例，随机分为MMF组（n=33）、CTX组（n=35），比较两组患儿完全缓解率、有效（完全缓解+部分缓解）率、尿蛋白转阴时间及不良反应等指标。

结果: 治疗3个月、6个月、12个月，MMF组与CTX组完全缓解率、有效率差异无统计学意义（P > 0.05）。两组尿蛋白转阴时间差异无统计学意义（P > 0.05）。两组患儿治疗期间不良反应发生率差异无统计学意义（P > 0.05）。

结论: MMF和CTX治疗具有大量蛋白尿的HSPN患儿的疗效和安全性相当。

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Conflict of interest statement

利益冲突声明：所有作者均声明不存在利益冲突。

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