Clinical evaluation of herbal extract niaoduqing in the treatmentofearly stage chronic renal failure

Ｃｌｉｎｉｃａｌｅｖａｌｕａｔｉｏｎｏｆｈｅｒｂａｌｅｘｔｒａｃｔｎｉａｏｄｕｑｉｎｇｉｎｔｈｅｔｒｅａｔｍｅｎｔｏｆｅａｒｌｙｓｔａｇｅｃｈｒｏｎｉｃｒｅｎａｌｆａｉｌｕｒｅ￥（刘俊）（潘振邦）ＬｉｕＪｕｎ，ＰａｎＺｈｅｎｂａｎｇ（Ｄｅｐａｒｔｍｅ...

Niaoduqing granules inhibits TGF-β1-induced epithelial-mesenchymal transition in human renal tubular epithelial HK-2 cells

Objective Chronic renal failure(CRF)is a worldwide public health burden.Niaoduqing granules(NDQ)is widely used for CRF treatment in China.However,the underlying mechanism of NDQ is not fully studied.This study is aimed to investigate whether NDQ ameliorate CRF by inhibiting transforming growth factor-β1(TGF-β1)-induced EMT in human renal tubular epithelial HK-2 cells.Methods 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenylterazolium bromide assay and colony formation assay were used to investigate the cytotoxicity of NDQ in HK-2 cells.Morphological changes of HK-2 cells after TGF-β1 or/and NDQ treatment were observed under a microscope.Wound-healing,migration and invasion assays were performed to determine the cell movement,migratory and invasive abilities,respectively.Western blot analysis was carried out to examine the protein levels of TGF-βreceptor I(TβRI)and epithelial-mesenchymal transition(EMT)-associated factors.Fluorescence confocal microscopy was applied to observe the organization of filamentous actin.Results NDQ suppressed TβRI expression dose-dependently.NDQ inhibited TGF-β1-stimulated EMT in HK-2 cells,supported by the evidences that NDQ prevented morphology change,attenuated cell migration and invasion,downregulated EMT factors and reorganized filamentous actin distribution in TGF-β1-stimulated HK-2 cells.Conclusions NDQ attenuates chronic renal failure which may be associated with inhibition of TβRI expression and EMT process.

Efficacy and Safety of Niaoduqing Particles for Delaying Moderate-to-severe Renal Dysfunction： A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study

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, naulticentcr clinical trial. Frorn May 2013 to December 2013,300 CKD patients with an estimated glomerular filtration rate （eGFR） between 20 and 45 ml ＂rain ~＂ 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） p, mol/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.

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

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(e GFR) 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 e GFRs 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 m L·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.

Meta-Analysis of Niaoduqing Granules Combined With RAAS System Blocker in the Treatment of Diabetic Nephropathy

To systematically evaluate the efficacy of urinary granules combined with RAAS system blockers in the treatment of diabetic nephropathy(DN).A meta-analysis of the data required in the literature in accordance with this study was performed using Rev Man 5.3 software.Fifteen randomized controlled trials were analyzed in the present study to evaluate the clinical effect of Niaoduqing-angiotensin converting enzyme inhibitors/angiotensin receptor blocker(ACEI/ARB)in DN patients.A total of 1063 patients were involved,including 538 patients receiving the combination treatment and 525 patients in the control group.The results showed that the clinical efficacy of Niaoduqing granule combined with ACEI/ARB was significantly better than of the control group(odds ratio=2.92,95%confidence interval[CI]1.76–4.86).The treatment combined with Niaoduqing granule decreased the 24-h urinary protein quantitation(mean difference[MD]0.71,95%CI 0.28–1.14)and urine albumin excretion rate(UAER)(MD 41.13,95%CI 26.66–55.59)levels.However,the combination group had no treatment advantage on reducing serumurea nitrogen(MD 0.86,95%CI 0.05–1.68,P=0.02)and fasting blood glucose(MD-0.03,95%CI-0.15–0.09,P=0.61).And there was no significance in adverse events between two groups(risk ratio=2.34,95%CI 0.69–7.95,P=0.17).Niaoduqing granule-ACEI/ARB combination group maybe as safe as ACEI/ARB alone,and the combination played an advantage in improvement in total effective rate,reduction of 24-h urinary protein quantitation and UAER.