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


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2019-03

AUTHORS

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

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•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 mL•min-1•1.73 m-2 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). More... »

PAGES

168-174

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s11655-018-2998-y

DOI

http://dx.doi.org/10.1007/s11655-018-2998-y

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1110133145

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30467695


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