Effects of Niaoduqing Particles (尿毒清颗粒) 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

doi:10.1007/s11655-018-2998-y

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

Original Article | Updated：2021-08-27

- Effects of Niaoduqing Particles (尿毒清颗粒) on Delaying Progression of Renal Dysfunction: A Post-trial, Open-Label, Follow-up Study
- Effects of Niaoduqing Particles (尿毒清颗粒) on Delaying Progression of Renal Dysfunction: A Post-trial, Open-Label, Follow-up Study
- Chinese Journal of Integrative Medicine 2019年25卷第3期页码：168-174
- Affiliations：
  
  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
- Author bio：
  
  Prof. CAI Guang-yan, caiguangyan@sina.com
  Corresponding to: Prof. CHEN Xiang-mei, Tel: 86-10-66935462, Fax: 86-10-68130297, E-mail: xmchen301@126.com
- Funds：
  
  the National Key Technology R&D Program(2015BAI12B06);Key Program of National Natural Science Foundation of China(81330019);General Program of National Natural Science Foundation of China(81670671);the Beijing Science and Technology Project(D171100002817002D181100000118002,;D181100000118004)
- DOI：10.1007/s11655-018-2998-y
  中图分类号：
- 纸质出版日期：2019-03-01，
  
  网络出版日期：2018-11-22，
  
  录用日期：2018-06-20
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Ying ZHENG, Nian-song WANG, Yu-ning LIU, 等. Effects of Niaoduqing Particles (尿毒清颗粒) on Delaying Progression of Renal Dysfunction: A Post-trial, Open-Label, Follow-up Study[J]. Chinese Journal of Integrative Medicine, 2019,25(3):168-174.

Ying ZHENG, Nian-song WANG, Yu-ning LIU, et al. Effects of Niaoduqing Particles (尿毒清颗粒) on Delaying Progression of Renal Dysfunction: A Post-trial, Open-Label, Follow-up Study[J]. Chinese Journal of Integrative Medicine, 2019,25(3):168-174.
Ying ZHENG, Nian-song WANG, Yu-ning LIU, 等. Effects of Niaoduqing Particles (尿毒清颗粒) on Delaying Progression of Renal Dysfunction: A Post-trial, Open-Label, Follow-up Study[J]. Chinese Journal of Integrative Medicine, 2019,25(3):168-174. DOI： 10.1007/s11655-018-2998-y.

Ying ZHENG, Nian-song WANG, Yu-ning LIU, et al. Effects of Niaoduqing Particles (尿毒清颗粒) on Delaying Progression of Renal Dysfunction: A Post-trial, Open-Label, Follow-up Study[J]. Chinese Journal of Integrative Medicine, 2019,25(3):168-174. DOI： 10.1007/s11655-018-2998-y.

摘要

Abstract

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 (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 (

=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

•1.73 m

-2

respectively (

=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 (

=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 (

=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•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. (Trial registration No. ChiCTR-TRC-12002448)

关键词

Keywords

chronic kidney diseasemoderate-to-severe renal dysfunctionNiaoduqing Particlespost-trial follow-upChinese medicine

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