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长期评估首剂利妥昔单抗治疗儿童激素依赖型微小病变肾病综合征。

Long Term Evaluations of First Single-dose Rituximab in Children with Steroid-Dependent Minimal-Change Nephrotic Syndrome.

机构信息

Department of Nephrology, Rheumatology and Immunology, Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.

出版信息

Ren Fail. 2024 Dec;46(2):2427173. doi: 10.1080/0886022X.2024.2427173. Epub 2024 Nov 26.

DOI:10.1080/0886022X.2024.2427173
PMID:39593209
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11610296/
Abstract

OBJECTIVE

To explore the long-term efficacy and safety of the first single dose of rituximab in children with steroid-dependent minimal-change nephrotic syndrome (SD-MCNS) over a two-year period after infusion.

METHODS

A 2-year retrospective observational study was performed on children with SD-MCNS who received the first single dose of rituximab (375 mg/m) from October 2011 to December 2018.

RESULTS

Seventy-seven patients (median age 8.17 years) were included. The efficacy of the first single-dose rituximab in children with SD-MCNS was 90.91% (70/77). An overall relapse rate of 78.33% was achieved. Older age at rituximab treatment onset (>8.46 years), a lower steroid-dependent dosage (<18.76 mg/m·d) and a higher CD4 T-cell count before rituximab treatment (>31.22%) were positively related to treatment efficacy (0.05). Male sex, younger age at rituximab treatment onset, a higher IgE level before rituximab treatment, and a higher white blood cell count and CD3 T-cell count at the time of steroid withdrawal were associated with disease relapse (0.05). A model for predicting relapse after rituximab treatment in SD-MCNS patients was established.

CONCLUSIONS

The first single-dose rituximab treatment for children with SD-MCNS was effective and safe. Greater efficacy was observed in patients who were older at rituximab treatment onset, had a lower steroid-dependent dosage, or had a higher CD4 T-cell count before rituximab treatment. In contrast, younger male patients with a higher IgE level experienced an increased occurrence of relapse.

摘要

目的

探讨首剂利妥昔单抗治疗儿童激素依赖性微小病变肾病综合征(SD-MCNS)患者在输注后 2 年内的长期疗效和安全性。

方法

对 2011 年 10 月至 2018 年 12 月接受首剂利妥昔单抗(375mg/m)治疗的 SD-MCNS 患儿进行了一项为期 2 年的回顾性观察研究。

结果

共纳入 77 例患儿(中位年龄 8.17 岁)。首剂利妥昔单抗治疗 SD-MCNS 患儿的疗效为 90.91%(70/77)。总复发率为 78.33%。利妥昔单抗治疗起始年龄较大(>8.46 岁)、激素依赖性剂量较低(<18.76mg/m·d)和利妥昔单抗治疗前 CD4 T 细胞计数较高(>31.22%)与治疗疗效呈正相关(0.05)。男性、利妥昔单抗治疗起始年龄较小、利妥昔单抗治疗前 IgE 水平较高、激素撤药时白细胞计数和 CD3 T 细胞计数较高与疾病复发相关(0.05)。建立了预测 SD-MCNS 患者利妥昔单抗治疗后复发的模型。

结论

首剂利妥昔单抗治疗儿童 SD-MCNS 有效且安全。利妥昔单抗治疗起始年龄较大、激素依赖性剂量较低或利妥昔单抗治疗前 CD4 T 细胞计数较高的患者疗效较好。相反,IgE 水平较高的年轻男性患儿复发发生率较高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6167/11610296/173ce453f7da/IRNF_A_2427173_F0002_C.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6167/11610296/551ee4817df9/IRNF_A_2427173_F0001_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6167/11610296/173ce453f7da/IRNF_A_2427173_F0002_C.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6167/11610296/551ee4817df9/IRNF_A_2427173_F0001_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6167/11610296/173ce453f7da/IRNF_A_2427173_F0002_C.jpg

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Long Term Evaluations of First Single-dose Rituximab in Children with Steroid-Dependent Minimal-Change Nephrotic Syndrome.长期评估首剂利妥昔单抗治疗儿童激素依赖型微小病变肾病综合征。
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本文引用的文献

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Pediatr Nephrol. 2023 Sep;38(9):3035-3042. doi: 10.1007/s00467-023-05913-1. Epub 2023 Apr 4.
2
Use of Rituximab in Childhood Idiopathic Nephrotic Syndrome.利妥昔单抗在儿童特发性肾病综合征中的应用。
Clin J Am Soc Nephrol. 2023 Apr 1;18(4):533-548. doi: 10.2215/CJN.08570722. Epub 2023 Feb 22.
3
Efficacy of rituximab therapy in children with nephrotic syndrome: a 10-year experience from an Iranian pediatric hospital.
利妥昔单抗治疗儿童肾病综合征的疗效:伊朗儿科医院 10 年经验。
BMC Pediatr. 2022 Jan 12;22(1):36. doi: 10.1186/s12887-022-03109-4.
4
Mycophenolate Mofetil after Rituximab for Childhood-Onset Complicated Frequently-Relapsing or Steroid-Dependent Nephrotic Syndrome.霉酚酸酯在利妥昔单抗治疗儿童起病的复杂频复发或激素依赖型肾病综合征后的应用。
J Am Soc Nephrol. 2022 Feb;33(2):401-419. doi: 10.1681/ASN.2021050643. Epub 2021 Dec 8.
5
Randomised controlled trial comparing rituximab to mycophenolate mofetil in children and young adults with steroid-dependent idiopathic nephrotic syndrome: study protocol.比较利妥昔单抗与吗替麦考酚酯治疗儿童及青年激素依赖型特发性肾病综合征的随机对照试验:研究方案。
BMJ Open. 2021 Nov 29;11(11):e052450. doi: 10.1136/bmjopen-2021-052450.
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Rituximab vs Low-Dose Mycophenolate Mofetil in Recurrence of Steroid-Dependent Nephrotic Syndrome in Children and Young Adults: A Randomized Clinical Trial.利妥昔单抗与低剂量霉酚酸酯治疗儿童和青年成人激素依赖型肾病综合征复发的随机临床试验
JAMA Pediatr. 2021 Jun 1;175(6):631-632. doi: 10.1001/jamapediatrics.2020.6150.
7
A review of nephrotic syndrome and atopic diseases in children.儿童肾病综合征与特应性疾病综述
Transl Androl Urol. 2021 Jan;10(1):475-482. doi: 10.21037/tau-20-665.
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Randomized clinical trial to compare efficacy and safety of repeated courses of rituximab to single-course rituximab followed by maintenance mycophenolate-mofetil in children with steroid dependent nephrotic syndrome.随机临床试验比较重复利妥昔单抗疗程与单次利妥昔单抗疗程后序贯霉酚酸酯维持治疗在儿童激素依赖性肾病综合征中的疗效和安全性。
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