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。
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.
作者
姚华
朱增燕
王文娟
桂环
王凤娇
张旭升
Yao Hua;Zhu Zengyan;Wang Wenjuan;Gui Huan;Wang Fengjiao;Zhang Xusheng(Children’s Hospital of Soochow University,Jiangsu Suzhou 215000,China)
出处
《儿科药学杂志》
CAS
2023年第4期21-24,共4页
Journal of Pediatric Pharmacy
基金
江苏省药学会-天晴医院药学基金,编号Q202120。
