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利妥昔单抗早期治疗儿童初发激素敏感型肾病综合征临床研究
张晓悦,邓芳
0
(安徽医科大学儿童医学中心/ 安徽医科大学第五临床医学院/ 安徽省儿童医院,合肥 230051)
摘要:
目的:探讨利妥昔单抗(RTX)早期治疗初发激素敏感型肾病综合征(SSNS)的疗效和安全性。方法:选取2021 年6 月至 2022 年2 月安徽省儿童医院诊断为初发SSNS 的28 例患儿,随机均分为RTX 组和激素对照组。RTX 组患儿1 周内予以 375 mg/ m2 RTX 治疗,激素对照组则按照循证指南进行规范诊疗,采用Kaplan-Meier 法对两组患儿的无复发生存率和无频复发 肾病综合征/ 激素依赖肾病综合征(FRNS/ SDNS)发生率进行比较,采用方差分析对治疗前后的白细胞介素-18(IL-18)水平进行 分析,采用秩和检验对RTX 治疗前后患儿的体质量指数(BMI) 进行比较。结果:以复发为终点事件,RTX 组和激素对照组的 2 年生存曲线差异有统计学意义(c2 =5. 49,P<0. 05),其2 年内无复发生存率分别为57. 14%和21. 42%。在RTX 组中,治疗1 个月 后的IL-18 水平较治疗前降低(P<0. 05),而患儿BMI 在治疗前与治疗后6 个月比较差异无统计学意义(P>0. 05)。结论:早期使用 RTX 治疗可提高SSNS 患儿无复发生存率,且IL-18 水平在RTX 治疗1 个月后降低,安全性较高,且无严重不良反应发生。
关键词:  肾病综合征  儿童  利妥昔单抗  白细胞介素-18
DOI:10.13407/j.cnki.jpp.1672-108X.2025.06.003
基金项目:2023 年安徽省临床医学研究转化专项项目,编号202304295107020063。
Clinical Study of Rituximab in the Early Treatment of Children with Initial Episode of Steroid-SensitiveNephrotic Syndrome
Zhang Xiaoyue, Deng Fang
(Children’s Medical Center of Anhui Medical University / The Fifth Clinical Medical College of Anhui Medical University / Anhui Provincial Children’s Hospital, Hefei 230051, China)
Abstract:
Objective: To probe into the efficacy and safety of rituximab (RTX) in the early treatment of children with initial episode of steroid-sensitive nephrotic syndrome (SSNS). Methods: A total of 28 children diagnosed with initial episode of SSNS in Anhui Children’s Hospital from Jun. 2021 to Feb. 2022 were extracted to be divided into the RTX group and steroid control group. The RTX group received 375 mg/ m2 RTX within one week, while the control group was treated with standard treatment based on current evidencebased guidelines. Kaplan-Meier analysis was performed to compare the relapse-free survival rates and incidence of frequent relapsing nephrotic syndrome/ steroid-dependent nephrotic syndrome ( FRNS/ SDNS). Analysis of variance was employed to compare the interleukin-18 (IL-18) levels before and after treatment. The Wilcoxon signed-rank test was used to compare body mass index (BMI) before and after RTX treatment. Results: Taking recurrence as the endpoint event, there was significant difference in the 2-year survival curves between the RTX group and steroid control group (c2 = 5. 49, P <0. 05), and the 2-year recurrence-free survival rates were 57. 14% and 21. 42%, respectively. In the RTX group, the IL-18 levels after treatment of one month was significantly lower than those before treatment (P<0. 05), while there was no significant difference in BMI between before treatment and after treatment of 6 months (P>0. 05). Conclusion: Early treatment of RTX can improve relapse-free survival rates in children with SSNS. Moreover, the IL-18 levels decrease after RTX treatment of one month, with higher safety and no severe adverse drug reactions.
Key words:  nephrotic syndrome  children  rituximab  interleukin-18

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