Efficacy and Safety of Abelmoschus manihot for Primary Glomerular Disease: A Prospective, Multicenter Randomized Controlled Clinical Trial

被引：113

作者：

Zhang, Li ^{[1
]}

Li, Ping ^{[1
]}

Xing, Chang-ying ^{[2
]}

Zhao, Jiu-yang ^{[3
]}

He, Ya-ni ^{[4
]}

Wang, Jian-qin ^{[5
]}

Wu, Xiong-fei ^{[6
]}

Liu, Zhang-suo ^{[7
]}

Zhang, Ai-ping ^{[8
]}

Lin, Hong-li ^{[9
]}

Ding, Xiao-qiang ^{[10
]}

Yin, Ai-ping ^{[11
]}

Yuan, Fa-huan ^{[12
]}

Fu, Ping ^{[13
]}

Hao, Li ^{[14
]}

Miao, Li-ning ^{[15
]}

Xie, Ru-juan ^{[16
]}

Wang, Rong ^{[17
]}

Zhou, Chun-hua ^{[18
]}

Guan, Guang-ju ^{[19
]}

Hu, Zhao ^{[20
]}

Lin, Shan ^{[21
]}

Chang, Ming ^{[22
]}

Zhang, Miao ^{[23
]}

He, Li-qun ^{[24
]}

Mei, Chang-lin ^{[25
]}

Wang, Li ^{[26
]}

Chen, Xiangmei ^{[1
]}

机构：

[1] Chinese Peoples Liberat Army Gen Hosp, Dept Nephrol, State Key Lab Kidney Dis 2011DAV00088, Beijing 100853, Peoples R China

[2] Nanjing Med Univ, Jiangsu Prov Hosp, Affiliated Hosp 1, Dept Nephrol, Nanjing, Jiangsu, Peoples R China

[3] Dalian Med Univ, Affiliated Hosp 2, Dept Nephrol, Dalian, Liaoning, Peoples R China

[4] Third Mil Med Univ, Daping Hosp, Dept Nephrol, Chongqing, Peoples R China

[5] Lanzhou Univ, Affiliated Hosp 2, Dept Nephrol, Lanzhou 730000, Peoples R China

[6] Third Mil Med Univ PLA, Affiliated Hosp 1, Dept Nephrol, Chongqing, Peoples R China

[7] Zhengzhou Univ, Affiliated Hosp 1, Dept Nephrol, Zhengzhou 450052, Peoples R China

[8] Jinan Gen Hosp PLA, Dept Nephrol, Jinan, Shandong, Peoples R China

[9] Dalian Med Univ, Affiliated Hosp 1, Dept Nephrol, Dalian, Liaoning, Peoples R China

[10] Fudan Univ, Shanghai Med Coll, Zhongshan Hosp, Div Nephrol, Shanghai 200433, Peoples R China

[11] Xi An Jiao Tong Univ, Affiliated Hosp 1, Dept Nephrol, Xian 710049, Peoples R China

[12] Third Mil Med Univ PLA, Affiliated Hosp 3, Dept Nephrol, Chongqing, Peoples R China

[13] Sichuan Univ, Huaxi Hosp, Dept Nephrol, Chengdu 610064, Peoples R China

[14] Anhui Med Univ, Affiliated Hosp 2, Dept Nephrol, Hefei, Peoples R China

[15] Jilin Univ, Hosp 2, Dept Nephrol, Changchun 130023, Jilin, Peoples R China

[16] Harbin Med Univ, Affiliated Hosp 1, Dept Nephrol, Harbin, Heilongjiang, Peoples R China

[17] Shandong Prov Hosp, Dept Nephrol, Jinan, Peoples R China

[18] PLA Navy Gen Hosp, Dept Nephrol, Beijing, Peoples R China

[19] Shandong Univ, Affiliated Hosp 2, Dept Nephrol, Jinan 250100, Peoples R China

[20] Qilu Hosp Shandong, Dept Nephrol, Jinan, Peoples R China

[21] Tianjin Med Univ, Gen Hosp, Dept Nephrol, Tianjin, Peoples R China

[22] Dalian Cent Hosp, Dept Nephrol, Dalian, Peoples R China

[23] Nanjing Med Univ, Drum Tower Hosp, Dept Nephrol, Nanjing, Peoples R China

[24] Shanghai Tradit Chinese Med Univ, Shuguang Hosp, Dept Nephrol, Shanghai, Peoples R China

[25] Second Mil Med Univ, Changzheng Hosp, Kidney Inst PLA, Div Nephrol, Shanghai, Peoples R China

[26] Sichuan Prov Peoples Hosp, Dept Nephrol, Chengdu, Peoples R China

来源：

AMERICAN JOURNAL OF KIDNEY DISEASES | 2014年 / 64卷 / 01期

基金：

中国国家自然科学基金;

关键词：

Primary glomerular disease; traditional Chinese medicine; Abelmoschus manihot; clinical trial; huangkui capsule; proteinuria; estimated glomerular filtration rate (eGFR); CHRONIC KIDNEY-DISEASE; IDIOPATHIC MEMBRANOUS NEPHROPATHY; CONVERTING ENZYME-INHIBITION; BLOOD-PRESSURE; RENAL PROTECTION; LOSARTAN; AMLODIPINE; PROTEINURIA; FLAVONOLS; EXCRETION;

D O I：

10.1053/j.ajkd.2014.01.431

中图分类号：

R5 [内科学]; R69 [泌尿科学（泌尿生殖系疾病）];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：57 / 65

页数：9

共 41 条

[1] [Anonymous], CHIN J INTEGR TRADIT
[2] [Anonymous], SHANDONG MED J
[3] [Anonymous], CHIN J CLIN
[4] [Anonymous], SHANDONG MED J
[5] Relapse or Worsening of Nephrotic Syndrome in Idiopathic Membranous Nephropathy Can Occur even though the Glomerular Immune Deposits Have Been Eradicated
Barnes, Chadwick E.
Wilmer, William A.
Hernandez, Raul A., Jr.
Valentine, Christopher
Hiremath, Leena S.
Nadasdy, Tibor
Satoskar, Anjali A.
Shim, Rose L.
Rovin, Brad H.
Hebert, Lee A.
[J]. NEPHRON CLINICAL PRACTICE, 2011, 119 (02): : C145 - C153
[6] Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy
Brenner, BM
Cooper, ME
de Zeeuw, D
Keane, WF
Mitch, WE
Parving, HH
Remuzzi, G
Snapinn, SM
Zhang, ZX
Shahinfar, S
[J]. NEW ENGLAND JOURNAL OF MEDICINE, 2001, 345 (12) : 861 - 869
[7] Cai X. Y., 2010, Contemp. Med, V16, P153, DOI [10.3969/j.issn.1009-4393.2010.31.114, DOI 10.3969/J.ISSN.1009-4393.2010.31.114]
[8] LONG-TERM BENEFITS OF ANGIOTENSIN-CONVERTING ENZYME-INHIBITOR THERAPY IN PATIENTS WITH SEVERE IMMUNOGLOBULIN A NEPHROPATHY - A COMPARISON TO PATIENTS RECEIVING TREATMENT WITH OTHER ANTIHYPERTENSIVE AGENTS AND TO PATIENTS RECEIVING NO THERAPY
CATTRAN, DC
GREENWOOD, C
RITCHIE, S
[J]. AMERICAN JOURNAL OF KIDNEY DISEASES, 1994, 23 (02) : 247 - 254
[9] Chen Ping, 2012, Zhongguo Zhong Yao Za Zhi, V37, P2252
[10] Chen Y, 2012, 49 EUR REN ASS EUR D

← 1 2 3 4 5 →