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一项比较间歇性环磷酰胺和皮质类固醇与利妥昔单抗治疗原发性膜性肾病的疗效和安全性的多中心回顾性研究。

A multicenter retrospective study on comparing the efficacy and safety of the therapy of intermittent cyclophosphamide and corticosteroids versus rituximab for primary membranous nephropathy.

机构信息

Department of Nephrology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.

Department of Nephrology, Shanghai Qingpu Branch of Zhongshan Hospital Affiliated with Fudan University, Shanghai, China.

出版信息

Ren Fail. 2024 Dec;46(2):2409353. doi: 10.1080/0886022X.2024.2409353. Epub 2024 Oct 1.

Abstract

BACKGROUND

Few clinical studies compare the long-term remission, relapse, and safety of rituximab (RTX) or a combination of intermittent intravenous infusion of cyclophosphamide (CTX) and oral corticosteroid for primary membranous nephropathy (PMN) patients.

METHODS

We collected multicenter retrospective data on PMN patients with nephrotic syndrome who received RTX or intermittent intravenous CTX with oral corticosteroids between 1 January 2019 and 31 January 2024. Patients were followed up until two years after receiving immunotherapy. The primary outcomes were a composite of complete or partial remission rates at 6, 12, and 24 months. The secondary outcomes were the relapse and safety evaluation.

RESULTS

Forty patients treated with RTX and 27 with the CTX regime were available for analysis. No significant difference in the remission rate at 6, 12, or 24 months was observed between the two groups ( > .05). Kaplan-Meier's survival analysis showed that the relapse-free cumulative survival rate of the RTX group was superior to that of the CTX group ( = .023). Compared with baseline, both the media of urine protein and serum albumin levels in the two groups showed a significant improvement at 6 months and maintained through to the second year. No significant difference in the occurrence of total side effects between the two groups ( = .160).

CONCLUSIONS

There was no difference in remission rates and safety between RTX versus intermittent intravenous CTX combined with oral corticosteroid treatment for patients with PMN within 2 years. RTX appeared to have benefits in terms of prolonging relapse-free survival.

摘要

背景

很少有临床研究比较利妥昔单抗(RTX)或间歇性静脉注射环磷酰胺(CTX)联合口服皮质类固醇治疗原发性膜性肾病(PMN)患者的长期缓解、复发和安全性。

方法

我们收集了 2019 年 1 月 1 日至 2024 年 1 月 31 日期间接受 RTX 或间歇性静脉 CTX 联合口服皮质类固醇治疗的肾病综合征PMN 患者的多中心回顾性数据。患者接受免疫治疗后随访 2 年。主要结局为 6、12 和 24 个月时完全或部分缓解率的复合。次要结局为复发和安全性评估。

结果

40 例接受 RTX 治疗和 27 例接受 CTX 方案治疗的患者可用于分析。两组在 6、12 或 24 个月时的缓解率无显著差异(>.05)。Kaplan-Meier 生存分析显示,RTX 组的无复发生存率优于 CTX 组(=0.023)。与基线相比,两组的尿蛋白中位数和血清白蛋白水平在 6 个月时均显著改善,并持续至第二年。两组总不良反应发生率无显著差异(=0.160)。

结论

RTX 与间歇性静脉 CTX 联合口服皮质类固醇治疗 PMN 患者在 2 年内缓解率和安全性无差异。RTX 在延长无复发生存方面似乎有优势。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e70f/11445897/9f8cd0b46a45/IRNF_A_2409353_F0001_B.jpg

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