真实世界中利妥昔单抗治疗儿童难治性肾病综合征的有效性与安全性的Meta分析  

Meta-analysis of efficacy and safety of rituximab for children with refractory nephrotic syndrome based on the real world

作　　者：任相阁 禹欣 张佳伟 赵沛东 翟文生[1,2] REN Xiangge;YU Xin;ZHANG Jiawei;ZHAO Peidong;ZHAI Wensheng(Pediatric Hospital,the First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450014,China;College of Pediatrics,Henan University of Chinese Medicine,Zhengzhou 450046,China)

机构地区：[1]河南中医药大学第一附属医院儿科医院,郑州450014 [2]河南中医药大学儿科医学院,郑州450046

出　　处：《中国药房》2024年第21期2668-2675,共8页China Pharmacy

基　　金：国家自然科学基金项目(No.81873339,No.82274577);中华中医药学会《儿童肾病综合征中医诊疗指南(修订)》项目(No.20210908-BZ-CACM)。

摘　　要：目的评价利妥昔单抗(RTX)在真实世界中治疗儿童难治性肾病综合征(RNS)的有效性和安全性。方法系统检索中国知网、万方、维普、PubMed、Embase、Web of Science、the Cochrane Library以及CINAHL数据库,筛选文献、评价质量并提取资料后,使用R 4.2.2和RStudio软件对提取的文献数据进行Meta分析。使用逐一剔除法进行敏感性分析来评估合并结果的稳健性。绘制漏斗图和Egger检验检测纳入文献是否存在发表偏倚。结果本研究共纳入26篇真实世界研究,涉及激素依赖型肾病综合征/频繁复发型肾病综合征(SDNS/FRNS)患儿996例,激素耐药型肾病综合征(SRNS)患儿205例。Meta分析结果表明,RTX治疗RNS的完全缓解(CR)率为46%(95%CI为37%~56%)、部分缓解(PR)率为22%(95%CI为14%~31%)、停药率为35%(95%CI为25%~44%)。亚组分析结果显示,RTX治疗SDNS/FRNS患儿的CR率为49%(95%CI为37%~62%)、PR率为25%(95%CI为0~50%)、停药率为41%(95%CI为29%~52%),治疗SRNS患儿的CR率为42%(95%CI为27%~56%)、PR率为22%(95%CI为12%~32%)、停药率为21%(95%CI为4%~38%)。使用RTX治疗SDNS/FRNS患儿1年及以内的复发率为39%(95%CI为21%~57%),2年及以上的复发率为18%(95%CI为18%~98%)。安全性方面,不良反应以轻微输液反应为主,发生率为13%(95%CI为8%~22%)。敏感性分析提示本研究结果稳健。轻微输液反应发生率存在发表偏倚。结论RTX治疗儿童RNS有效且安全。OBJECTIVE To evaluate the efficacy and safety of rituximab(RTX)in the treatment of children with refractory nephrotic syndrome(RNS)based on the real world by meta-analysis.METHODS A systematic search was conducted on CNKI,Wanfang,VIP,PubMed,Embase,Web of Science,the Cochrane Library,and CINAHL databases to strictly screen the literature and evaluate their quality.A meta-analysis was performed on the extracted literature data using R 4.2.2 and RStudio software.RESULTS A total of 26 real-world studies were included in this study,involving 996 children with steroid-dependent nephrotic syndrome/frequente-relapse nephrotic syndrome(SDNS/FRNS)and 205 children with steroid-resistant nephrotic syndrome(SRNS).The results of the meta-analysis showed that the complete remission(CR)rate of RTX treatment for RNS was 46%(95%CI:37%-56%),the partial remission(PR)rate was 22%(95%CI:14%-31%),and the discontinuation rate was 35%(95%CI:25%-44%).The results of subgroup analysis showed that the CR rate of RTX treatment in SDNS/FRNS children was 49%(95%CI:37%-62%),PR rate was 25%(95%CI:0-50%),discontinuation rate was 41%(95%CI:29%-52%);the CR rate in SRNS children was 42%(95%CI:27%-56%),PR rate was 22%(95%CI:12%-32%),discontinuation rate was 21%(95%CI:4%-38%).The recurrence rate in children with SDNS/FRNS was 39%(95%CI:21%-57%)within 1 year or less,18%(95%CI:18%-98%)in 2 years and more.As for safety,the majority of adverse reactions were mild infusion reactions,with an incidence of 13%(95%CI:8%-22%).Sensitivity analysis suggested that the results were robust.There was publication bias in mild infusion reaction rate.CONCLUSIONS RTX is effective and safe in the treatment of RNS in children.

关 键 词：难治性肾病综合征 频繁复发 激素依赖 激素耐药 真实世界 儿童 

分 类 号：R969.3[医药卫生—药理学] R726.9[医药卫生—药学]