Analysis of Severe Adverse Drug Events of Rituximab Treatment in Children with Nephrotic Syndrome

Yao Hua; Zhu Zengyan; Wang Wenjuan; Gui Huan; Wang Fengjiao; Zhang Xusheng

doi:10.13407/j.cnki.jpp.1672-108X.2023.04.006

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Analysis of Severe Adverse Drug Events of Rituximab Treatment in Children with Nephrotic Syndrome

更新时间：2023-04-28

- Analysis of Severe Adverse Drug Events of Rituximab Treatment in Children with Nephrotic Syndrome
- Vol. 29, Issue 4, Pages: 21-24(2023)
- 作者机构：
  
  苏州大学附属儿童医院,江苏,苏州,215000
- 作者简介：
- 基金信息：
- DOI：10.13407/j.cnki.jpp.1672-108X.2023.04.006
  CLC：
- Published：2023，
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Yao Hua, Zhu Zengyan, Wang Wenjuan, et al. Analysis of Severe Adverse Drug Events of Rituximab Treatment in Children with Nephrotic Syndrome. [J]. 29(4):21-24(2023)
DOI：

Yao Hua, Zhu Zengyan, Wang Wenjuan, et al. Analysis of Severe Adverse Drug Events of Rituximab Treatment in Children with Nephrotic Syndrome. [J]. 29(4):21-24(2023) DOI： 10.13407/j.cnki.jpp.1672-108X.2023.04.006.

摘要

目的:通过分析利妥昔单抗(RTX)治疗儿童原发性肾病综合征(PNS)时出现的相关严重不良事件(SAE)

探讨RTX 治疗儿童PNS 时发生SAE 的相关危险因素

为临床安全使用RTX 提供参考。方法:收集苏州大学附属儿童医院肾脏免疫科2016 年12 月至2020 年12 月应用RTX 治疗PNS 患儿的临床资料

包括患儿性别、年龄、发生SAE 的名称及具体临床表现

对可能引起SAE 的相关因素

使用Cox 回归进行多因素分析。用Kaplan-Meier 曲线描述生存变化情况

并采用Log-Rank 检验比较生存曲线的差异。结果:共收集44 例PNS 患儿

起病年龄(4. 73±0. 35) 岁

初始使用RTX 年龄(10. 16±3. 47) 岁

随访时间1. 50 (2. 05)年。44 例患儿中

12 例患儿至少出现1 次可能与RTX 相关的SAE

其中男10 例(83. 33%)

女2 例(16. 67%)。超敏反应与感染为较常见的SAE。初始使用RTX 的年龄是发生SAE 的危险因素。初始使用RTX 的年龄每增加1 岁

发生SAE 的风险减少23. 8%。结论:RTX 在儿童中

总体安全性较好。年龄越小的患儿使用RTX 发生SAE 的风险越高。

Abstract

Objective: To analyze the related severe adverse events (SAE) of rituximab (RTX) in children with primary nephrotic syndrome (PNS)

explore the related risk factors of SAE in the treatment of children with RTX during PNS

and provide a reference for the safe use of RTX in clinical practice. Methods: A retrospective study was carried out based on the data of children with PNS treated with RTX from December 2016 to December 2020 in the Department of Kidney and Immunology

Children’ s Hospital of Soochow University

including the patient’s gender

age

name of SAE and specific clinical manifestations. Multivariate analysis was performed using Cox regression to analyze the SAE related causes. Kaplan-Meier curve was used to describe the changes of survival

and Log-Rank test was used to compare the differences of survival curves. Results: A total of 44 children with PNS were collected. The age of onset was 4. 73±0. 35 years old

the age of initial RTX use was 10. 16±3. 47 years old

and the follow-up time was 1. 50(2. 05)years. Of the 44 patients

12 had at least one SAE that may be related to RTX. There were 10 male patients (83. 33%) and 2 female patients (16. 67%). Hypersensitivity reactions and infections were the more common SAE. Age at initial RTX use was a risk factor for SAE. The risk of SAE was reduced by 23. 8% for each 1-year increase in age at initiation of RTX. Conclusion: RTX is generally considered safe in children. Younger children are at higher risk of SAE with RTX.

关键词

利妥昔单抗儿童原发性肾病综合征严重不良事件

Keywords

rituximabchildrenprimary nephrotic syndromesevere adverse event

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