| 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。 |
| 关键词: 利妥昔单抗 儿童 原发性肾病综合征 严重不良事件 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2023.04.006 |
|
| 基金项目:江苏省药学会-天晴医院药学基金,编号Q202120。 |
|
| 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 |
| ((Children’s Hospital of Soochow
University, Jiangsu Suzhou 215000, China)) |
| 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. |
| Key words: rituximab children primary nephrotic syndrome severe adverse event |
