Efficacy and safety of tripterygium wilfordii multiglycosides in idiopathic membranous nephropathy Protocol for an open-label randomized controlled clinical trial

被引:1
作者
Geng, Chanyu [1 ,2 ]
Li, Qiang [3 ]
Pu, Lei [1 ,2 ]
Yang, Hongling [1 ,2 ]
Li, Guisen [1 ,2 ]
Feng, Yunlin [1 ,2 ,3 ]
机构
[1] Sichuan Prov Peoples Hosp, Nephrol Dept, Chengdu 610072, Peoples R China
[2] Univ Elect Sci & Technol China, Med Sch, Chengdu, Peoples R China
[3] Univ New South Wales, Fac Med, George Inst Global Hlth, Sydney, NSW, Australia
关键词
efficacy; idiopathic membranous nephropathy; open-label; randomized controlled trial; safety; tripterygium wilfordii multiglycosides; DIAGNOSIS;
D O I
10.1097/MD.0000000000028842
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective: Tripterygium wilfordii multiglycosides has been demonstrated to be effective in reducing proteinuria and alleviate edema in patients with chronic kidney disease. We aim to evaluate its efficacy and safety in idiopathic membranous nephropathy. Methods and analysis: This is an randomized, open-labeled, controlled clinical trial. Twenty eligible patients with idiopathic membranous nephropathy will be randomly assigned into the intervention group and the control group at a rate of 1:1. Patients in the intervention group will receive tripterygium wilfordii multiglycosides tablets (1-1.5 mg/kg body weight/d, orally) in addition to the original treatment of angiotensin converting enzyme inhibitor/angiotensin receptor blocker, while the control group will continue with the original treatment of angiotensin converting enzyme inhibitor/angiotensin receptor blocker. The treatment course is 6 months, and clinical variables of patients will be measured at baseline and each monthly follow-up. The primary efficacy outcome measure is absolute decrease in urinary protein quantity after 6 months of treatment compared with baseline at randomization. The secondary efficacy outcome measures include absolute decrease in urine albumin-creatinine ratio in spot urine after 6 months of treatment compared with baseline at randomization, the percentage of patients who reached effective clinical response, and the percentage of patients who developed composite renal endpoint. Safety outcome measures include incidence of adverse events, incidence of serious adverse events, and death.
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相关论文
共 14 条
[1]   Diagnosis and natural course of membranous nephropathy [J].
Glassock, RJ .
SEMINARS IN NEPHROLOGY, 2003, 23 (04) :324-332
[2]  
Guo XY., 2017, CHIN J INTEGR TRAD W, V18, P374
[3]   Membranous nephropathy: A review on the pathogenesis, diagnosis, and treatment [J].
Lai, Wei Ling ;
Yeh, Ting Hao ;
Chen, Ping Min ;
Chan, Chieh Kai ;
Chiang, Wen Chih ;
Chen, Yung Ming ;
Wu, Kwan Dun ;
Tsai, Tun Jun .
JOURNAL OF THE FORMOSAN MEDICAL ASSOCIATION, 2015, 114 (02) :102-111
[4]   Comparison of tripterygium wilfordii multiglycosides and tacrolimus in the treatment of idiopathic membranous nephropathy: a prospective cohort study [J].
Liu, Shanshan ;
Li, Xiayu ;
Li, Heng ;
Liang, Qian ;
Chen, Jun ;
Chen, Jianghua .
BMC NEPHROLOGY, 2015, 16
[5]   Executive summary of the KDIGO 2021 Guideline for the Management of Glomerular Diseases [J].
Rovin, Brad H. ;
Adler, Sharon G. ;
Barratt, Jonathan ;
Bridoux, Frank ;
Burdge, Kelly A. ;
Chan, Tak Mao ;
Cook, H. Terence ;
Fervenza, Fernando C. ;
Gibson, Keisha L. ;
Glassock, Richard J. ;
Jayne, David R. W. ;
Jha, Vivekanand ;
Liew, Adrian ;
Liu, Zhi-Hong ;
Mejia-Vilet, Juan M. ;
Nester, Carla M. ;
Radhakrishnan, Jai ;
Rave, Elizabeth M. ;
Reich, Heather N. ;
Ronco, Pierre ;
Sanders, Jan-Stephan F. ;
Sethi, Sanjeev ;
Suzuki, Yusuke ;
Tang, Sydney C. W. ;
Tesar, Vladimir ;
Vivarelli, Marina ;
Wetzels, Jack F. M. ;
Lytvyn, Lyubov ;
Craig, Jonathan C. ;
Tunnicliffe, David J. ;
Howell, Martin ;
Tonelli, Marcello A. ;
Cheung, Michael ;
Earley, Amy ;
Floege, Jurgen .
KIDNEY INTERNATIONAL, 2021, 100 (04) :753-779
[6]   Retrospective analysis of tacrolimus combined with Tripterygium wilfordii polyglycoside for treating idiopathic membranous nephropathy [J].
Shang, Shun-Lai ;
Cai, Guang-Yan ;
Duan, Shu-wei ;
Li, Ping ;
Li, Qing-Gang ;
Chen, Xiang-Mei .
BMC NEPHROLOGY, 2018, 19
[7]   Use of Tripterygium wilfordii Hook F for immune-mediated inflammatory diseases: progress and future prospects [J].
Song, Cong-ying ;
Xu, Ying-ge ;
Lu, Yuan-qiang .
JOURNAL OF ZHEJIANG UNIVERSITY-SCIENCE B, 2020, 21 (04) :280-290
[8]  
Tian Ya-Ge, 2019, Zhongguo Zhong Yao Za Zhi, V44, P3399, DOI 10.19540/j.cnki.cjcmm.20190527.408
[9]   Triptolide ameliorates fine particulate matter-induced podocytes injury via regulating NF-κB signaling pathway [J].
Wan, Qiang ;
Liu, Zhongyong ;
Yang, Ming ;
Deng, Peng ;
Tang, Nana ;
Liu, Yanwei .
BMC MOLECULAR AND CELL BIOLOGY, 2020, 21 (01)
[10]   Efficacy and safety of Tripterygium wilfordii Hook F for CKD in Mainland China: A systematic review and meta-analysis [J].
Wang, Duo ;
Zhao, Xiao-Han ;
Cui, Yi ;
Zhang, Tian-Tian ;
Wang, Fang ;
Hu, Yong-Hong .
PHYTOTHERAPY RESEARCH, 2018, 32 (03) :436-451