Effects of Niaoduqing Particles(尿毒清颗粒)on Delaying Progression of Renal Dysfunction:A Post-trial,Open-Label,Follow-up Study

作     者：ZHENG Ying WANG Nian-song LIU Yu-ning HE Li-qun JIAN Gui-hua LIU Xu-sheng NI Zhao-hui CHENG Xiao-hong LIN Hong-li ZHOU Wen-hua WANG Ya-ping FANG Jing-ai HE Ya-ni YANG Hong-tao ZHAO Li-juan DING Han-lu WANG Li-hua YU Ren-huan LI Wen-ge YE Zhi-ming GUO Wang ZHAN Yong-li MAO Hui-juan HU Zhao YAO Chen CAI Guang-yan CHEN Xiang-mei 

作者机构：Department of Nephrology Chinese People's Liberation Army General Hospital Chinese People's Liberation Army Institute of Nephrology State Key Laboratory of Kidney Diseases (2011DAV00088) National Clinical Research Center for Kidney Diseases Department of Nephrology and Rheumatology Affiliated Sixth People's Hospital Shanghai Jiaotong University Department of Nephrology Dongzhimen Hospital The First Affiliated Hospital of Beijing University of Chinese Medicine Department of Nephrology Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Department of Nephrology Guangdong Provincial Hospital of Chinese Medicine Department of Nephrology Renji Hospital Shanghai Jiaotong University Department of Nephrology Shaanxi Traditional Chinese Medicine Hospital Department of Nephrology First Affiliated Hospital of Dalian Medical University Department of Nephrology Second Hospital of Jilin University Department of Nephrology Army General Hospital Department of Nephrology First Affiliated Hospital of Shanxi Medical University Department of Nephrology Daping Hospital Army Medical University Department of Nephrology First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Department of Nephrology Xijing Hospital Air Force Medical University Department of Nephrology University of Electronic Science and Technology Sichuan Academy of Sciences and Sichuan Provincial People's Hospital Department of Nephrology Second Affiliated Hospital of Shanxi Medical University Department of Nephrology Xiyuan Hospital China Academy of Chinese Medical Sciences Department of Nephrology China-Japan Friendship Hospital Department of Nephrology Guangdong General Hospital Guangdong Academy of Medical Sciences Department of Nephrology Beijing Friendship Hospital Capital Medical University Department of Nephrology Guang'anmen Hospital of China Academy of Traditional Chinese Medical Sciences Department of Nephrology Jiangsu Province Hospital First Affiliated Hospital of Nanjing Medical University Department of Nephrology Qilu Hospital of Shandong University Peking University Clinical Research Institute Peking University 

出 版 物：《Chinese Journal of Integrative Medicine》 (中国结合医学杂志（英文版）)

年 卷 期：2019年第25卷第3期

页      面：168-174页

核心收录：

学科分类：1006[医学-中西医结合] 100602[医学-中西医结合临床] 10[医学] 

基　　金：Supported by the National Key Technology R&D Program(No.2015BAI12B06) Key Program of National Natural Science Foundation of China(No.81330019) General Program of National Natural Science Foundation of China(No.81670671) the Beijing Science and Technology Project(No.D171100002817002,D181100000118002,and D181100000118004) 

主　　题：chronic kidney disease moderate-to-severe renal dysfunction Niaoduqing Particles post-trial follow-up Chinese medicine 

摘      要：Objective: To follow up the participants of the randomized clinical trial Efficacy and Safety of Niaoduqing Particles(尿毒清颗粒) for Delaying Moderate-to-Severe Renal Dysfunction, and assess the long-term effects of Niaoduqing Particles on delaying the progression of renal dysfunction. Methods: Participants, who had previously been randomly assigned to receive Niaoduqing Particles or placebo for 24 weeks(146 cases in each group), were invited to follow-up and all were administered Niaoduqing Particles 5 g thrice daily and 10 g before bedtime for 24 weeks. The primary endpoints were changes in baseline serum creatinine(Scr) and estimated glomerular filtration rate(e GFR) after completion of the open-label treatment period. Results: After the double-blind period, the median(interquartile range) changes in Scr were 1.1(–13.0–24.1) and 11.7(–2.6–42.9) μmol/L for the Niaoduqing Particle and placebo groups, respectively(P=0.008), and the median changes in e GFRs were –0.2(–4.3–2.7) and –2.21(–5.7–0.8) mL·min^(-1)·1.73 m^(-2), respectively(P=0.016). There were significant differences in the double-blind period changes in renal function between groups. After the open-label period, the median changes in Scr were 9.0(–10.0–41.9) and 17.5(–6.0–50.0) μmol/L for the Niaoduqing Particle and placebo groups according to baseline grouping, respectively(P=0.214), and the median changes in eGFRs were –2.3(–6.4–1.9) and –3.7(–7.5–1.1) mL·min^(-1)·1.73 m^(-2), respectively(P=0.134). There were no statistical differences in the open-label period changes in renal function between groups. The eGFR reduction of participants who accepted Niaoduqing Particle treatment for 48 weeks was projected to 2.5 m L·min^(-1)·1.73 m(-2) per year. Conclusions: Niaoduqing Particles appear to have long-term efficacy for patients with moderate-to-severe renal dysfunction. Although there was no statistical difference, the early use of Niaoduqing Paticles seems to ameliorate the worsening of renal function.