Efficacy and Safety of Niaoduqing Particles for Delaying Moderate-to-severe Renal Dysfunction: A Randomized,Double-blind, Placebo-controlled, Multicenter Clinical Study
- Author:
Zheng YING
1
;
Cai GUANG-YAN
;
He LI-QUN
;
Lin HONG-LI
;
Cheng XIAO-HONG
;
Wang NIAN-SONG
;
Jian GUI-HUA
;
Liu XU-SHENG
;
Liu YU-NING
;
Ni ZHAO-HUI
;
Fang JING-AI
;
Ding HAN-LU
;
Guo WANG
;
He YA-NI
;
Wang LI-HUA
;
Wang YA-PING
;
Yang HONG-TAO
;
Ye ZHI-MING
;
Yu REN-HUAN
;
Zhao LI-JUAN
;
Zhou WEN-HUA
;
Li WEN-GE
;
Mao HUI-JUAN
;
Zhan YONG-LI
;
Hu ZHAO
;
Yao CHEN
;
Wei RI-BAO
;
Chen XIANG-MEI
Author Information
- Keywords: Chronic Kidney Disease; Moderate-to-severe Renal Dysfunction; Niaoduqing Particles; Randomized Controlled Trial; Traditional Chinese Medicine
- From: Chinese Medical Journal 2017;130(20):2402-2409
- CountryChina
- Language:Chinese
- Abstract: 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,multicenter clinical trial.From May 2013 to December 2013,300 CKD patients with an estimated glomerular filtration rate (eGFR) between 20 and 45 ml,min-1· 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) μmol/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.
