Efficacy and safety of Abelmoschus manihot for primary glomerular disease: a prospective, multicenter randomized controlled clinical trial
| Autor: | Fa-huan Yuan, Xiangmei Chen, Ai-ping Yin, Zhangsuo Liu, Xiaoqiang Ding, Ping Fu, Ping Li, Changying Xing, Rong Wang, Hongli Lin, Zhao Hu, Ai-ping Zhang, Li-Ning Miao, Chun-hua Zhou, Li Zhang, Guang-ju Guan, Xiongfei Wu, Li-qun He, Jiu-yang Zhao, Ming Chang, Ru-juan Xie, Li Wang, Miao Zhang, Changlin Mei, Jian-qin Wang, Yani He, Li Hao, Shan Lin |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Male medicine.medical_specialty China Manihot Biopsy Urology Renal function Kidney Losartan traditional Chinese medicine Glomerulonephritis Abelmoschus medicine Humans Abelmoschus manihot Prospective Studies Medicine Chinese Traditional Renal Insufficiency Chronic Proteinuria biology business.industry estimated glomerular filtration rate (eGFR) clinical trial Middle Aged biology.organism_classification medicine.disease Surgery Clinical trial Treatment Outcome Nephrology huangkui capsule Moderate proteinuria Drug Therapy Combination Female proteinuria medicine.symptom business Nephrotic syndrome Primary glomerular disease Kidney disease medicine.drug Drugs Chinese Herbal Glomerular Filtration Rate |
| Zdroj: | American journal of kidney diseases : the official journal of the National Kidney Foundation. 64(1) |
| ISSN: | 1523-6838 |
| Popis: | BackgroundAbelmoschus manihot, a single medicament of traditional Chinese medicine, has been widely used to treat kidney disease. This is the first randomized controlled clinical trial to assess its efficacy and safety in patients with primary glomerular disease.Study DesignProspective, open-label, multicenter, randomized, controlled, clinical trial.Setting & ParticipantsFrom May 2010 to October 2011, a total of 417 patients with biopsy-proven primary glomerular disease from 26 hospitals participated in the study.InterventionsA manihot in the form of a huangkui capsule, 2.5g, 3 times per day; losartan potassium, 50mg/d; or combined treatment, a huangkui capsule at 2.5g 3 times per day, was combined with losartan potassium, 50mg/d. The duration of intervention was 24 weeks.Outcomes & MeasurementsThe primary outcome was change in 24-hour proteinuria from baseline after treatment. Change in estimated glomerular filtration rate (eGFR) from baseline after treatment was a secondary outcome. The 24-hour proteinuria was measured every 4 weeks and eGFR was measured at 0, 4, 12, and 24 weeks.ResultsMean baseline urine protein excretion was 1,045, 1,084, and 1,073mg/d in the A manihot, losartan, and combined groups, respectively, and mean eGFR was 108, 106, and 106mL/min/1.73m2, respectively. After 24 weeks of treatment, mean changes in proteinuria were protein excretion of −508, −376, and −545mg/d, respectively (P=0.003 for A manihot vs losartan and P0.05), and there were no severe adverse events in any group.LimitationsResults cannot be generalized to those with nephrotic syndrome or reduced eGFR.ConclusionsA manihot is a promising therapy for patients with primary kidney disease (chronic kidney disease stages 1-2) with moderate proteinuria. |
| Databáze: | OpenAIRE |
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