Intravenous methylprednisolone for nephrotic syndrome with minimal change lesions in adults: a randomized controlled trial.

IF 4.8 2区 医学 Q1 TRANSPLANTATION
Jinxia Chen, Ruting Li, Hua Guo, Tianyu Zhu, Yongzhi Xu, Cuiwei Yao, Huafeng Liu
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引用次数: 0

Abstract

Background: Patients with minimal change nephrotic syndrome (MCNS) usually experience severe oedema, which can affect the absorption of oral corticosteroid during the first 2 weeks. We conducted a randomized controlled trial (RCT) to compare the efficacy of intravenous (IV) isovalent methylprednisolone induction followed by oral prednisone therapy with conventional oral prednisone therapy in highly oedematous MCNS patients, aiming to provide a better therapy for MCNS patients.

Methods: A single-centre, open-label, parallel-arm RCT was performed in the Nephrology Department of the Affiliated Hospital of Guangdong Medical University. Patients who met the inclusion criteria were enrolled in our study from May 2015 to October 2020 and were randomized to receive conventional oral steroid or 2 weeks of IV methylprednisolone followed by oral prednisone.

Results: A total of 117 patients were enrolled and randomly assigned to either the sequential group (n = 57) or the oral group (n = 60). The total remission rate in the sequential group was higher than in the oral group after treatment for 2 weeks and 4 weeks (P = .032, P = .027). The complete remission (CR) rate was higher in the sequential group than in the oral group (63.3% versus 41.5%; P = .031) after treatment for 2 weeks. The time to achieve CR was shorter in the sequential group than in the oral group, with a statistically significant difference {14.0 days [95% confidence interval (CI) 13.5-14.5] versus 16.0 days [95% CI 12.7-19.3], P = .024}. There were no significant differences in relapse rate (24.5% versus 28.3%; P = .823) and time to relapse (155 ± 103 days versus 150.7 ± 103.7 days; P = .916) between two groups.

Conclusion: This study suggested that highly oedematous MCNS patients who received IV isovalent methylprednisolone induction therapy followed by oral prednisone achieved earlier remission than the conventional oral prednisone regimen without differences in relapse rates or adverse effects. Short-term IV methylprednisolone followed by oral prednisone may be a better choice for MCNS patients with severe oedema.

静脉注射甲基强的松龙治疗成人肾病综合征微小病变:随机对照试验。
背景和假设:微小病变肾病综合征(MCNS)患者通常会出现严重水肿,这会影响头两周口服皮质类固醇的吸收。我们进行了一项随机对照试验,比较在高度水肿的 MCNS 患者中静脉注射异戊酸甲泼尼龙诱导后口服泼尼松治疗与传统口服泼尼松治疗的疗效,旨在为 MCNS 患者提供更好的治疗方法:广东医科大学附属医院肾内科开展了一项单中心、开放标签、平行臂随机对照试验。符合纳入条件的患者于2015年5月至2020年10月期间入组,随机接受常规口服类固醇或2周静脉注射甲泼尼龙后口服泼尼松治疗:117名患者被随机分配到序贯组(57人)或口服组(60人)。治疗 2 周和 4 周后,序贯组的总缓解率高于口服组(P = 0.032,P = 0.027)。治疗 2 周后,序贯组的完全缓解率高于口服组(63.3% 对 41.5%,P = 0.031)。序贯组达到 CR 的时间比口服组短,差异有统计学意义(14.0 天,95% CI [13.5 至 14.5] 对 16.0 天,95% CI [12.7 至 19.3],P = 0.024)。两组复发率(24.5% vs 28.3%,P = 0.823)和复发时间(155 ± 103 天 vs 150.7 ± 103.7 天,P = 0.916)无明显差异:该研究表明,高度水肿的 MCNS 患者在接受静脉注射异戊酸甲基强的松龙诱导治疗后,再口服泼尼松,比传统的口服泼尼松方案更早获得缓解,且复发率和不良反应无差异。对于高度水肿的 MCNS 患者来说,短期静脉注射甲泼尼龙后口服泼尼松可能是更好的选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Nephrology Dialysis Transplantation
Nephrology Dialysis Transplantation 医学-泌尿学与肾脏学
CiteScore
10.10
自引率
4.90%
发文量
1431
审稿时长
1.7 months
期刊介绍: Nephrology Dialysis Transplantation (ndt) is the leading nephrology journal in Europe and renowned worldwide, devoted to original clinical and laboratory research in nephrology, dialysis and transplantation. ndt is an official journal of the [ERA-EDTA](http://www.era-edta.org/) (European Renal Association-European Dialysis and Transplant Association). Published monthly, the journal provides an essential resource for researchers and clinicians throughout the world. All research articles in this journal have undergone peer review. Print ISSN: 0931-0509.
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