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利妥昔单抗治疗激素依赖型或频繁复发型儿童肾病综合征的疗效与安全性:一项随机对照试验的荟萃分析

Efficacy and safety of rituximab in children with steroid-dependent or frequently relapsing nephrotic syndrome: a meta-analysis of randomized controlled trials.

作者信息

Luo Ningxin, Shen Xiaoyu, Xia Hui, Xu Yazhen, Zhong Shuwen, Shan Hongmei, Zhao Li

机构信息

Shanghai Children's Medical Center (SCMC) affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.

出版信息

Arch Med Sci. 2023 Feb 27;21(2):588-596. doi: 10.5114/aoms/161675. eCollection 2025.

DOI:10.5114/aoms/161675
PMID:40395883
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12087312/
Abstract

INTRODUCTION

To explore the efficacy and safety of rituximab (RTX) in children with steroid-dependent nephrotic syndrome (SDNS) or frequently relapsing nephrotic syndrome (FRNS) through meta-analysis.

MATERIAL AND METHODS

Meta-analysis searches were performed before November 30th, 2021, using the PubMed, Embase, Web of Science, and Cochrane Library databases to collect randomized controlled trials (RCTs). FRNS or SDNS children younger than 18 years of age were included. The RTX group was treated with RTX combined with conventional therapy, whereas the control group was given conventional therapy. Review Manager 5.3 and STATA 15.0 were used to perform the statistical analyses.

RESULTS

Of 1450 screened articles, a total of eight studies eligible for inclusion involving 476 patients were included. As compared to the control group (RR = 1.91, 95% CI: 1.16, 3.14, < 0.05), RTX did not show significant improvement in the short term (RR = 2.48, 95% CI: 0.85, 7.25, = 0.10). However, the RTX group achieved a higher short-term complete remission rate when two studies with heterogeneity were excluded (RR = 2.17, 95% CI: 1.65, 2.84, < 0.001). Proteinuria levels were reduced more effectively in the RTX group (MD = -1.84, 95% CI: -2.42, -1.26, < 0.001). The RTX group and the control group had no significant differences in adverse events.

CONCLUSIONS

RTX can be considered as an effective and safe treatment option for children with SDNS or FRNS. However, it is necessary to conduct further studies via RCTs to evaluate the persistent long-term effects.

摘要

引言

通过荟萃分析探讨利妥昔单抗(RTX)治疗激素依赖型肾病综合征(SDNS)或频繁复发型肾病综合征(FRNS)患儿的疗效和安全性。

材料与方法

于2021年11月30日前进行荟萃分析检索,使用PubMed、Embase、科学网和考克兰图书馆数据库收集随机对照试验(RCT)。纳入年龄小于18岁的FRNS或SDNS患儿。RTX组采用RTX联合传统疗法治疗,而对照组给予传统疗法。使用Review Manager 5.3和STATA 15.0进行统计分析。

结果

在筛选的1450篇文章中,共纳入8项符合纳入标准的研究,涉及476例患者。与对照组相比(RR = 1.91,95% CI:1.16,3.14,P < 0.05),RTX在短期内未显示出显著改善(RR = 2.48,95% CI:0.85,7.25,P = 0.10)。然而,排除两项存在异质性的研究后,RTX组的短期完全缓解率更高(RR = 2.17,95% CI:1.65,2.84,P < 0.001)。RTX组的蛋白尿水平降低更有效(MD = -1.84,95% CI:-2.42,-1.26,P < 0.001)。RTX组和对照组在不良事件方面无显著差异。

结论

RTX可被视为治疗SDNS或FRNS患儿的一种有效且安全的治疗选择。然而,有必要通过RCT进行进一步研究以评估持续的长期效果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5ff/12087312/f66facae4ead/AMS-21-2-161675-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5ff/12087312/e80af916f1b1/AMS-21-2-161675-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5ff/12087312/3fdbc8751bde/AMS-21-2-161675-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5ff/12087312/7a9b0ee54e30/AMS-21-2-161675-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5ff/12087312/f66facae4ead/AMS-21-2-161675-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5ff/12087312/e80af916f1b1/AMS-21-2-161675-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5ff/12087312/3fdbc8751bde/AMS-21-2-161675-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5ff/12087312/7a9b0ee54e30/AMS-21-2-161675-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5ff/12087312/f66facae4ead/AMS-21-2-161675-g004.jpg

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Arch Med Sci. 2022 Jan 14;18(1):275-278. doi: 10.5114/aoms/145587. eCollection 2022.
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The Efficacy and Safety of Rituximab for Childhood Steroid-Dependent Nephrotic Syndrome: A Systematic Review and Meta-Analysis.利妥昔单抗治疗儿童激素依赖型肾病综合征的疗效与安全性:一项系统评价和荟萃分析
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