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利妥昔单抗治疗儿童难治性肾病综合征的疗效和安全性:一项随机对照试验的荟萃分析。

Efficacy and safety of rituximab for childhood refractory nephrotic syndrome: A meta-analysis of randomized controlled trials.

机构信息

Department of Nephrology, University of Electronic Science and Technology, Sichuan Academy of Sciences & Sichuan Provincial People's Hospital, Chengdu 610072, Sichuan China.

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.

出版信息

Med Clin (Barc). 2021 Nov 12;157(9):418-426. doi: 10.1016/j.medcli.2020.07.039. Epub 2020 Oct 16.

Abstract

BACKGROUND

Idiopathic nephrotic syndrome is the most common glomerular disease in children, but there are still some difficulties in treating childhood steroid-dependent or steroid-resistant nephrotic syndrome (SDNS/SRNS). Rituximab (RTX) might be an effective and safe choice.

METHODS

Studies were searched from PubMed, Web of Science, Cochrane library and some Chinese databases up to April 2020. Only randomized controlled trials (RCT) were included.

RESULTS

Of 1383 screened articles, 6 RCTs with 334 participants were included. RTX was better than the control group at improving relapse-free rate in the short term [RR (risk ratio) (95% CI (confidence interval)), 1.84(1.41, 2.39)]. As for long-term, RTX did not show significant improvement [RR (95% CI), 4.43(.57, 34.67)]; but in subgroup analysis, RTX was still better than conventional drugs and tacrolimus [RR (95% CI), 9.91(1.95, 50.52) and 1.42(1.15, 1.75), respectively]. And there was a difference between the two groups of prednisolone dose after treatment [MD (mean difference) (95% CI), -.22(-.36, -.09) mg/kg/d)]. However, RTX did not significantly improve serum albumin and creatinine [MD (95% CI), 3.46(-1.40, 8.32)g/L and -3.66(-11.79, 4.48)μmol/L, respectively]. No significant differences between the RTX and the control group were found in total adverse events (AEs) or serious AEs.

CONCLUSION

Childhood SDNS/SRNS patients appear to benefit from RTX in relapse-free rate and dose of prednisolone use. Also, RTX did not significantly increase the incidence of AEs. But RTX did not show improvements in biological indicators, more studies are required to explain the effect of RTX.

摘要

背景

特发性肾病综合征是儿童中最常见的肾小球疾病,但在治疗儿童激素依赖性或激素抵抗性肾病综合征(SDNS/SRNS)方面仍存在一些困难。利妥昔单抗(RTX)可能是一种有效且安全的选择。

方法

从 PubMed、Web of Science、Cochrane 图书馆和一些中文数据库中检索到 2020 年 4 月前的研究。仅纳入随机对照试验(RCT)。

结果

在筛选出的 1383 篇文章中,纳入了 6 项 RCT 共 334 名参与者。RTX 组在短期内改善无复发生存率方面优于对照组[RR(风险比)(95%CI),1.84(1.41,2.39)]。而在长期来看,RTX 并未显示出显著改善[RR(95%CI),4.43(0.57,34.67)];但在亚组分析中,RTX 仍优于常规药物和他克莫司[RR(95%CI),9.91(1.95,50.52)和 1.42(1.15,1.75)]。而且两组治疗后泼尼松剂量也存在差异[MD(均数差)(95%CI),-2.22(-0.36,-0.09)mg/kg/d]。然而,RTX 对血清白蛋白和肌酐的改善不明显[MD(95%CI),3.46(-1.40,8.32)g/L 和-3.66(-11.79,4.48)μmol/L]。RTX 组和对照组的总不良事件(AE)或严重 AE 发生率无显著差异。

结论

儿童 SDNS/SRNS 患者似乎从 RTX 的无复发生存率和泼尼松剂量获益。而且,RTX 并未显著增加 AE 的发生率。但是,RTX 对生物标志物的改善不明显,需要更多的研究来解释 RTX 的作用。

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