标题：Effects of Niaoduqing Particles 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; 更多 作者机构：Department of Nephrology, Chinese People\'s Liberation Army General Hospital, Chinese People\'s Liberation Army Institute of Nephrology, State Key Lab 更多
通讯作者：Cai, GY;Chen, XM
通讯作者地址：[Cai, GY; Chen, XM]Chinese Peoples Liberat Army Gen Hosp, Chinese Peoples Liberat Army Inst Nephrol, Dept Nephrol, State Key Lab Kidney Dis 2011DAV000 更多
关键词：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 (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) μ mol/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·min1·1.73 m2,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) μ mol/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 m2,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·min1·1.73 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.