Efficacy and Safety of Abelmoschus manihot for Primary Glomerular Disease: A Prospective, Multicenter Randomized Controlled Clinical Trial
Efficacy and Safety of Abelmoschus manihot for Primary Glomerular Disease: A Prospective, Multicenter Randomized Controlled Clinical Trial
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秋葵治疗原发性肾小球疾病的疗效和安全性：一项前瞻性、多中心随机对照临床试验
DOI：
10.1053/j.ajkd.2014.01.431
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发表时间：
2014-07-01
影响因子：
13.2
通讯作者：
Chen, Xiangmei
中科院分区：
文献类型：
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作者：
Zhang, Li;Li, Ping;Chen, Xiangmei
背景：马氏单药已被广泛应用于肾脏疾病的治疗。这是首个评估其在原发性肾小球疾病患者中的有效性和安全性的随机对照临床试验。研究设计：前瞻性、开放标签、多中心、随机、对照、临床试验。背景与参与者：2010年5月至2011年10月，共有来自26家医院的417例经活检证实的原发性肾小球疾病患者参与了研究。干预措施：黄葵胶囊，2.5 g，每天3次；氯沙坦钾，50 mg/d；或联合治疗：黄葵胶囊各2.5 g，每日3次，联合氯沙坦钾50 mg/d。干预时间为24周。结果和测量：主要结果是治疗后24小时蛋白尿从基线改变。治疗后估计肾小球滤过率（eGFR）较基线的变化是次要结果。每4周测定24小时蛋白尿，并于0、4、12、24周测定eGFR。结果：A - manihot、氯沙坦和联合用药组的平均基线尿蛋白排泄量分别为1,045、1,084和1,073 mg/d，平均eGFR分别为108、106和106 mL/min/1.73 m(2)。治疗24周后，蛋白尿的平均变化是蛋白质排泄量分别为-508、-376和-545 mg/d（曼尼热vs氯沙坦P = 0.003，联合治疗vs氯沙坦P < 0.001）。平均eGFR无显著变化。三组患者不良反应发生率比较差异无统计学意义（P < 0.05），两组患者均无严重不良事件发生。局限性：结果不能推广到肾病综合征或eGFR降低的患者。结论：对于原发性肾病（慢性肾病1-2期）伴有中度蛋白尿的患者，A - manihot是一种很有希望的治疗方法。(C) 2014年由国家肾脏基金会，Inc。
Background: Abelmoschus 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 Design: Prospective, open-label, multicenter, randomized, controlled, clinical trial.Setting & Participants: From May 2010 to October 2011, a total of 417 patients with biopsy-proven primary glomerular disease from 26 hospitals participated in the study.Interventions: A manihot in the form of a huangkui capsule, 2.5 g, 3 times per day; losartan potassium, 50 mg/d; or combined treatment, a huangkui capsule at 2.5 g 3 times per day, was combined with losartan potassium, 50 mg/d. The duration of intervention was 24 weeks.Outcomes & Measurements: The 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.Results: Mean baseline urine protein excretion was 1,045, 1,084, and 1,073 mg/d in the A manihot, losartan, and combined groups, respectively, and mean eGFR was 108, 106, and 106 mL/min/1.73 m(2), respectively. After 24 weeks of treatment, mean changes in proteinuria were protein excretion of -508, -376, and -545 mg/d, respectively (P = 0.003 for A manihot vs losartan and P < 0.001 for the combined treatment vs losartan). Mean eGFR did not change significantly. The incidence of adverse reactions was not different among the 3 groups (P > 0.05), and there were no severe adverse events in any group. Limitations: Results cannot be generalized to those with nephrotic syndrome or reduced eGFR.Conclusions: A manihot is a promising therapy for patients with primary kidney disease (chronic kidney disease stages 1-2) with moderate proteinuria. (C) 2014 by the National Kidney Foundation, Inc.