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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 被引量:23
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作者 Ying Zheng Guang-Yan Cai +25 位作者 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 《Chinese Medical Journal》 SCIE CAS CSCD 2017年第20期2402-2409,共8页
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 limit... 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 CKD.Methods: 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) ml.min-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. 展开更多
关键词 Chronic Kidney Disease Moderate-to-severe Renal Dysfunction niaoduqing particles Randomized Controlled Trial Traditional Chinese Medicine
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