Efficacy and safety of Mahuang Fuzi and Shenzhuo Decoction for treatment of primary membranous nephropathy: a multicenter prospective trial.

IF 3 3区 医学 Q1 UROLOGY & NEPHROLOGY
Renal Failure Pub Date : 2024-12-01 Epub Date: 2024-03-14 DOI:10.1080/0886022X.2024.2320834
Naiqian Zhang, Hanxue Jiang, Haoran Dai, Shuxian Huang, Qihan Zhao, Na Zhang, Wenbin Liu, Zhaocheng Dong, Yu Gao, Xuan Dong, Yuehong Hu, Fanyu Hou, Hongliang Rui, Qingquan Liu, Baoli Liu
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Abstract

Background: This study aims to undertake a comprehensive assessment of the effectiveness and safety profile of Mahuang Fuzi and Shenzhuo Decoction (MFSD) in the management of primary membranous nephropathy (PMN), within the context of a prospective clinical investigation.

Methods: A multicenter, open-label clinical trial was executed on patients diagnosed with PMN. These individuals were subjected to MFSD therapy for a duration of at least 24 months, with primary outcome of clinical remission rates. The Cox regression analysis was employed to discern the pertinent risk factors exerting influence on the efficacy of MFSD treatment, with scrupulous monitoring of any adverse events.

Results: The study comprised 198 participants in total. Following 24 months of treatment, the remission rate was 58.6% (116/198). Among the subgroup of 130 participants subjected to a 36-month follow-up, the remission rate reached 70% (91/130). Subgroup analysis revealed that neither a history of immunosuppressive therapy (HIST) nor an age threshold of ≥60 years exhibited a statistically significant impact on the remission rate at the 24-month mark (p > .05). Multivariate Cox regression analyses elucidated HIST, nephrotic syndrome, or mass proteinuria, and a high-risk classification as noteworthy risk factors in the context of MFSD treatment. Remarkably, no fatalities resulting from side effects were documented throughout the study's duration.

Conclusions: This trial establishes the efficacy of MFSD as a treatment modality for membranous nephropathy. MFSD demonstrates a favorable side effect profile, and remission rates are consistent across patients, irrespective of HIST and age categories.

麻黄附子神曲汤治疗原发性膜性肾病的有效性和安全性:一项多中心前瞻性试验。
研究背景本研究旨在通过前瞻性临床研究,全面评估麻黄附子神曲汤(MFSD)治疗原发性膜性肾病(PMN)的有效性和安全性:方法:对确诊为原发性膜性肾病的患者进行多中心、开放标签临床试验。这些患者接受了至少 24 个月的 MFSD 治疗,主要结果是临床缓解率。研究采用了Cox回归分析,以找出影响MFSD疗效的相关风险因素,并严格监测任何不良事件:研究共有 198 名参与者。治疗 24 个月后,缓解率为 58.6%(116/198)。在接受 36 个月随访的 130 名参与者中,缓解率达到 70%(91/130)。亚组分析显示,免疫抑制治疗史(HIST)和≥60 岁的年龄阈值对 24 个月的缓解率均无显著统计学影响(P > .05)。多变量 Cox 回归分析显示,HIST、肾病综合征或大量蛋白尿以及高风险分类是 MFSD 治疗过程中值得注意的风险因素。值得注意的是,在整个研究过程中,没有因副作用导致死亡的记录:这项试验证实了膜性肾病治疗方法 MFSD 的疗效。MFSD显示出良好的副作用,而且患者的缓解率一致,与HIST和年龄类别无关。
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来源期刊
Renal Failure
Renal Failure 医学-泌尿学与肾脏学
CiteScore
3.90
自引率
13.30%
发文量
374
审稿时长
1 months
期刊介绍: Renal Failure primarily concentrates on acute renal injury and its consequence, but also addresses advances in the fields of chronic renal failure, hypertension, and renal transplantation. Bringing together both clinical and experimental aspects of renal failure, this publication presents timely, practical information on pathology and pathophysiology of acute renal failure; nephrotoxicity of drugs and other substances; prevention, treatment, and therapy of renal failure; renal failure in association with transplantation, hypertension, and diabetes mellitus.
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