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

Ying Zheng; Nian-song Wang; Yu-ning Liu; Li-qun HE; Gui-hua Jian; Xu-sheng Liu; Zhao-hui NI; Xiao-hong Cheng; Hong-li Lin; Wen-hua Zhou; Ya-ping Wang; Jing-ai Fang; Ya-ni HE; Hong-tao Yang; Li-juan Zhao; Han-lu Ding; Li-hua Wang; Ren-huan YU; Wen-ge LI; Zhi-ming YE; Wang Guo; Yong-li Zhan; Hui-juan Mao; Zhao HU; Chen Yao; Guang-yan Cai; Xiang-mei Chen

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

Author: Ying ZHENG ¹ ; Nian-Song WANG ² ; Yu-Ning LIU ³ ; Li-Qun HE ⁴ ; Gui-Hua JIAN ² ; Xu-Sheng LIU ⁵ ; Zhao-Hui NI ⁶ ; Xiao-Hong CHENG ⁷ ; Hong-Li LIN ⁸ ; Wen-Hua ZHOU ⁹ ; Ya-Ping WANG ¹⁰ ; Jing-Ai FANG ¹¹ ; Ya-Ni HE ¹² ; Hong-Tao YANG ¹³ ; Li-Juan ZHAO ¹⁴ ; Han-Lu DING ¹⁵ ; Li-Hua WANG ¹⁶ ; Ren-Huan YU ¹⁷ ; Wen-Ge LI ¹⁸ ; Zhi-Ming YE ¹⁹ ; Wang GUO ²⁰ ; Yong-Li ZHAN ²¹ ; Hui-Juan MAO ²² ; Zhao HU ²³ ; Chen YAO ²⁴ ; Guang-Yan CAI ²⁵ ; Xiang-Mei CHEN ²⁶
Author Information

1. 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, Beijing, 100853, China.
2. Department of Nephrology and Rheumatology, Affiliated Sixth People's Hospital, Shanghai Jiaotong University, Shanghai, 200233, China.
3. Department of Nephrology, Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, 100700, China.
4. Department of Nephrology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 200021, China.
5. Department of Nephrology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong, 510120, China.
6. Department of Nephrology, Renji Hospital, Shanghai Jiaotong University, Shanghai, 200127, China.
7. Department of Nephrology, Shaanxi Traditional Chinese Medicine Hospital, Xi'an, Shaanxi, 710003, China.
8. Department of Nephrology, First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, 116011, China.
9. Department of Nephrology, Second Hospital of Jilin University, Changchun, 130041, China.
10. Department of Nephrology, Army General Hospital, Beijing, 100700, China.
11. Department of Nephrology, First Affiliated Hospital of Shanxi Medical University, Taiyuan, 030001, China.
12. Department of Nephrology, Daping Hospital, Army Medical University, Chongqing, 400042, China.
13. Department of Nephrology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300192, China.
14. Department of Nephrology, Xijing Hospital, Air Force Medical University, Xi'an, 710032, China.
15. Department of Nephrology, University of Electronic Science and Technology, Sichuan Academy of Sciences and Sichuan Provincial People's Hospital, Chengdu, 610072, China.
16. Department of Nephrology, Second Affiliated Hospital of Shanxi Medical University, Taiyuan, 030001, China.
17. Department of Nephrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
18. Department of Nephrology, China-Japan Friendship Hospital, Beijing, 100029, China.
19. Department of Nephrology, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, 510030, China.
20. Department of Nephrology, Beijing Friendship Hospital, Capital Medical University, Beijing, 100050, China.
21. Department of Nephrology, Guang'anmen Hospital of China Academy of Traditional Chinese Medical Sciences, Beijing, 100053, China.
22. Department of Nephrology, Jiangsu Province Hospital, First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.
23. Department of Nephrology, Qilu Hospital of Shandong University, Jinan, 250012, China.
24. Peking University Clinical Research Institute, Peking University, Beijing, 100191, China.
25. 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, Beijing, 100853, China. caiguangyan@sina.com.
26. 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, Beijing, 100853, China. xmchen301@126.com.
Publication Type:Journal Article
Keywords: Chinese medicine; Niaoduqing Particles; chronic kidney disease; moderate-to-severe renal dysfunction; post-trial follow-up
MeSH: Adult; Disease Progression; Double-Blind Method; Drugs, Chinese Herbal; therapeutic use; Female; Follow-Up Studies; Glomerular Filtration Rate; drug effects; Humans; Kidney Diseases; drug therapy; physiopathology; Male; Middle Aged; Outcome Assessment (Health Care)
From: Chinese journal of integrative medicine 2019;25(3):168-174
CountryChina
Language:English
Abstract: OBJECTIVE:To follow up the participants of the randomized clinical trial "Efficacy and Safety of Niaoduqing Particles () 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 (eGFR) 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 eGFRs were-0.2 (-4.3-2.7) and-2.21 (-5.7-0.8) mL•min•1.73 m, 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•1.73 m, 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 mL•min•1.73 m per year.
CONCLUSION: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. (Trial registration No. ChiCTR-TRC-12002448).