Chen Jinxia, Li Ruting, Guo Hua, Zhu Tianyu, Xu Yongzhi, Yao Cuiwei, Liu Huafeng
Department of Nephrology, National Clinical Key Specialty Construction Program (2023); Institute of Nephrology; Guangdong Provincial Key Laboratory of Autophagy and Major Chronic Non-communicable Diseases; Key Laboratory of Prevention and Management of Chronic Kidney Disease of Zhanjiang City; Affiliated Hospital of Guangdong Medical, Zhanjiang, Guangdong, People's Republic of China.
Department of Nephrology, Boai hospital of Zhongshan, Zhongshan Women and Children's hospital, Affiliated Hospital of Southern Medical University, Zhongshan, China.
Nephrol Dial Transplant. 2025 Apr 1;40(4):731-738. doi: 10.1093/ndt/gfae208.
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.
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.
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.
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.
微小病变肾病综合征（MCNS）患者通常会出现严重水肿，这可能会影响最初2周内口服糖皮质激素的吸收。我们进行了一项随机对照试验（RCT），比较静脉注射等渗甲泼尼龙诱导治疗后口服泼尼松与传统口服泼尼松治疗对高度水肿的MCNS患者的疗效，旨在为MCNS患者提供更好的治疗方法。
在广东医科大学附属医院肾内科进行了一项单中心、开放标签、平行组RCT。符合纳入标准的患者于2015年5月至2020年10月纳入本研究，并随机分为接受传统口服类固醇治疗组或接受2周静脉注射甲泼尼龙后口服泼尼松治疗组。
共纳入117例患者，随机分为序贯组（n = 57）或口服组（n = 60）。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（CR）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%置信区间（CI）13.5 - 14.5]对16.0天[95%CI 12.7 - 19.3]，P = 0.024}。两组的复发率（24.5%对28.3%；P = 0.823）和复发时间（155±103天对150.7±103.7天；P = 0.916）无显著差异。
本研究表明，接受静脉注射等渗甲泼尼龙诱导治疗后口服泼尼松的高度水肿MCNS患者比传统口服泼尼松方案缓解更早，复发率和不良反应无差异。短期静脉注射甲泼尼龙后口服泼尼松可能是重度水肿MCNS患者的更好选择。
