Efficacy and safety of Mahuang Fuzi and Shenzhuo Decoction for treatment of primary membranous nephropathy: a multicenter prospective trial
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-l...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2024-12-01
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| Series: | Renal Failure |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/0886022X.2024.2320834 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Naiqian Zhang |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-54821b2d5ea44ed4be8eb92147c4c9d7 |
| institution | Kabale University |
| issn | 0886-022X 1525-6049 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Renal Failure |
| spelling | doaj-art-54821b2d5ea44ed4be8eb92147c4c9d72025-01-23T04:17:49ZengTaylor & Francis GroupRenal Failure0886-022X1525-60492024-12-0146110.1080/0886022X.2024.2320834Efficacy and safety of Mahuang Fuzi and Shenzhuo Decoction for treatment of primary membranous nephropathy: a multicenter prospective trialNaiqian Zhang0Hanxue Jiang1Haoran Dai2Shuxian Huang3Qihan Zhao4Na Zhang5Wenbin Liu6Zhaocheng Dong7Yu Gao8Xuan Dong9Yuehong Hu10Fanyu Hou11Hongliang Rui12Qingquan Liu13Baoli Liu14Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, ChinaBeijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, ChinaBeijing Hospital of Traditional Chinese Medicine, Shunyi Branch, Beijing, ChinaBeijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, ChinaBeijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, ChinaBeijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, ChinaSchool of Life Sciences, Beijing University of Chinese Medicine, Beijing, ChinaSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaBeijing Chaoyang District Emergency Medical Rescuing Center, Beijing, ChinaBeijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, ChinaBeijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, ChinaChangchun University of Chinese Medicine, Jilin, ChinaBeijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, ChinaBeijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, ChinaBeijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, ChinaBackground 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.https://www.tandfonline.com/doi/10.1080/0886022X.2024.2320834Primary membranous nephropathytraditional Chinese medicineMahuang Fuzi and Shenzhuo Decoctionefficacysafety |
| spellingShingle | 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 Efficacy and safety of Mahuang Fuzi and Shenzhuo Decoction for treatment of primary membranous nephropathy: a multicenter prospective trial Renal Failure Primary membranous nephropathy traditional Chinese medicine Mahuang Fuzi and Shenzhuo Decoction efficacy safety |
| title | Efficacy and safety of Mahuang Fuzi and Shenzhuo Decoction for treatment of primary membranous nephropathy: a multicenter prospective trial |
| title_full | Efficacy and safety of Mahuang Fuzi and Shenzhuo Decoction for treatment of primary membranous nephropathy: a multicenter prospective trial |
| title_fullStr | Efficacy and safety of Mahuang Fuzi and Shenzhuo Decoction for treatment of primary membranous nephropathy: a multicenter prospective trial |
| title_full_unstemmed | Efficacy and safety of Mahuang Fuzi and Shenzhuo Decoction for treatment of primary membranous nephropathy: a multicenter prospective trial |
| title_short | Efficacy and safety of Mahuang Fuzi and Shenzhuo Decoction for treatment of primary membranous nephropathy: a multicenter prospective trial |
| title_sort | efficacy and safety of mahuang fuzi and shenzhuo decoction for treatment of primary membranous nephropathy a multicenter prospective trial |
| topic | Primary membranous nephropathy traditional Chinese medicine Mahuang Fuzi and Shenzhuo Decoction efficacy safety |
| url | https://www.tandfonline.com/doi/10.1080/0886022X.2024.2320834 |
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