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Efficacy and Safety of niaoduqing particles for Delaying Moderate-to-severe Renal Dysfunction： A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study

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Chinese Medical Journal 2017年第20期130卷 2402-2409页

作者： Ying Zheng Guang-Yan Cai Li-Qun He Hong-Li Lin Xiao-Hong Cheng Nian-Song Wang Gui-Hua Jian Xu-Sheng Liu Yu-Ning Liu Zhao-Hui Ni Jing-Ai Fang Han-Lu Ding Wang Guo Ya-Ni He Li-Hua Wang Ya-Ping Wang Hong-Tao Yang Zhi-Ming Ye Ren-Huan YU Li-Juan Zhao Wen-Hua Zhou Wen-Ge Li Hui-Juan Mao Yong-Li Zhan Zhao Hu Chen Yao Ri-Bao Wei Xiang-Mei Chen Department of Nephrology Chinese People's Liberation Army General Hospital Chinese People's Liberation Army Institute of Nephrology State Key Laboratory of Kidney Diseases (2011DAVO0088) National Clinical Research Center for Kidney Diseases Beijing 100853 China Department of Nephrology Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Shanghai 200021 China Department of Nephrology First Affiliated Hospital of Dalian Medical University Dalian Liaoning 116011 China Department of Nephrology Shaanxi Traditional Chinese Medicine Hospital Xi'an Shaanxi 710003 China Department of Nephrology and Rheumatology Affiliated Sixth People's Hospital Shanghai Jiao Tong University Shanghai 200233 China Department of Nephrology Guangdong Provincial Hospital of Chinese Medicine Guangzhou Guangdong 510120 China Department of Nephrology Dongzhimen Hospital The First Affiliated Hospital of Beijing University of Chinese Medicine Beijing 100700 China Department of Nephrology Renji Hospital Shanghai Jiao Tong University Shanghai 200127 China Department of Nephrology First Affiliated Hospital of Shanxi Medical University Taiyuan Shanxi 030001 China Department of Nephrology University of Electronic Science and Technology Sichuan Academy of Sciences and Sichuan Provincial People's Hospital Chengdu Sichuan 610072 China Department of Nephrology Beijing Friendship Hospital Capital Medical University Beijing 100050 China Department of Nephrology Daping Hospital Third Military Medical University Chongqing 400042 China Department of Nephrology Second Affiliated Hospital of Shanxi Medical University Taiyuan Shanxi 030001 China Department of Nephrology Army General Hospital Beijing 100700 China Department of Nephrology First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tiaojin 300192 China Department of Nephrology Guangdong General Hospital Guangdong Academy of Medical Sciences Guangzhou Guangdong 510030 China Department o

Background： Chronic kidney disease （CKD） with moderate-to-severe renal dysfunction usually exhibits an irreversible course, and available treatments for delaying the progression to end-stage renal disease are limited. This study aimed to assess the efficacy and safety of the traditional Chinese medicine, niaoduqing particles, for delaying renal dysfunction in patients with stage 3b-4 ***： The present study was a prospective, randomized, double-blind, placebo-controlled, naulticentcr clinical trial. Frorn May 2013 to December 2013,300 CKD patients with an estimated glomerular filtration rate （eGFR） between 20 and 45 ml ＂rain ~＂ 1.73 m 2, aged 18-70 years were recruited from 22 hospitals in 11 Chinese provinces. Patients were randomized in a 1：1 ratio to either a test group, which was administered niaoduqing particles 5 g thrice daily and 10 g before bedtime for 24 weeks, or a control group, which was administered a placebo using the same methods. The primary endpoints were changes in baseline serum creatinine （Scr） and eGFR after completion of treatment. The primary endpoints were analyzed using Student＇s t-test or Wilcoxon＇s rank-sum test. The present study reported results based on an intention-to-treat （ITT） analysis. Results： A total of 292 participants underwent the ITT analysis. At 24 weeks, the median （interquartile range） change in Scr was 1.1 （-13.0-24.1） and 11.7 （-2.6-42.9） p, mol/L for the test and control groups, respectively （Z = 2.642, P = 0.008）, and the median change in eGFR was -0.2 （-4.3-2.7） and -2.2 （-5.7-0.8） ***-1·1.73 m-2, respectively （Z = -2.408, P = 0.016）. There were no significant differences in adverse events between the groups. Conclusions： niaoduqing particles safely and effectively delayed CKD progression in patients with stage 3b-4 CKD. This traditional Chinese medicine may be a promising alternative medication for patients with moderate-to-severe renal dysfunction.

关键词： Chronic Kidney Disease Moderate-to-severe Renal Dysfunction niaoduqing particles Randomized Controlled Trial Traditional Chinese Medicine

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