Effects of Niaoduqing Particles () on Delaying Progression of Renal Dysfunction: A Post-trial, Open-Label, Follow-up Study / 中国结合医学杂志

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).

Influence of Niaoduqing Particles on Microinflammatory in Patients with Maintenance Hemodialysis / 中国中医药信息杂志

Objective To investigate the effect of Niaoduqing Particles on the microinflammatory state in patients with maintenance hemodialysis. Methods Totally 240 patients with hemodialysis for more than 6 months were randomly divided into conventional hemodialysis group, Chinese medicine group (treated with Niaoduqing Particles) and western medicine group (treated with Vitamin E), 80 cases in each group, with 30 healthy people as control group. The levels of hs-CRP, IL-6 and HCY were detected before and after 1, 3, 6 months of treatment. Results Before treatment, the levels of inflammatory factors in hemodialysis patients were higher than control group. And after 3 months of treatment, the levels of hs-CRP, IL-6 and HCY of Chinese medicine group were decreased. And after 6 months of treatment, the levels of inflammatory factors were decreased obviously compared with pretherapy (P<0.01), and the difference with the conventional hemodialysis group was significant (P<0.01). Compared with pretherapy, the changes of inflammatory factors of western medicine group were statistically insignificant. Conclusion Niaoduqing Particles can significantly improve the microinflammatory state in maintenance hemodialysis patients, and the effect is superior to Vitamin E.