Beneficial effects of Fu-Zheng-Qu-Zhuo oral liquid combined with standard integrated therapy in patients with chronic kidney disease (stage 3-4): A randomized placebo-controlled clinical trial.

BACKGROUND: The high worldwide prevalence of chronic kidney disease (CKD) is a critical health problem and the development of more effective therapies is urgently needed. We conducted a randomized, double-blinded, placebo-controlled clinical trial from October 2010 to December 2012 to assess whether Fu-Zheng-Qu-Zhuo oral liquid (FZQZ) has a beneficial effect in preventing CKD progression when added to standard integrated therapies. METHODS: Patients with CKD stage 3 to 4 from 3 hospitals in Beijing, China were enrolled. Patients were randomly assigned to the FZQZ or placebo groups and were treated with standard integrated therapy plus FZQZ or placebo (20 mL each time, 3 times/d) for 12 months. Patients received post-trial follow-up until October 2014. The primary outcome was the estimated glomerular filtration rate (eGFR)-Slope (mL/min per 1.73 m2 per month) during the in-trial time, which was calculated by the eGFR regression curve estimated from each serum creatinine measurement during the in-trial period. Secondary outcomes were changes in 24-h urine protein excretion (24-h UP) and albumin and hemoglobin levels from baseline during the in-trial period. Time to composite endpoint events (initiation of long-term dialysis, doubling of serum creatinine, or CKD-related death during the in-trial and post-trial phases) was assessed as a secondary outcome. RESULTS: A total of 68 patients (43 in the FZQZ group and 25 in the placebo group) completed the in-trial and post-trial phases, with an average follow-up time of 31.6 ±â€Š9.6months. The FZQZ group had amean eGFR-Slope of 0.25 ±â€Š1.44 as compared with -0.72 ±â€Š1.46 (mL/min per 1.73m2 per month) in the placebo group during the in-trial period (P = .003). The FZQZ group showed decreased 24-h UP, with a change from baseline of -0.08 (interquartile range [IQR], -0.33 to 0.01) versus 0.01 (IQR, -0.19 to 0.33) g/24h in the placebo group (P = .049). Decreased risk of composite endpoint events was observed only in the post-trial phase (hazard ratio = 0.42, 95% confidence interval: 0.16-1.11, P = .038). No significant differences in albumin and hemoglobin level changes were observed. CONCLUSION: Adding FZQZ oral liquid to standard integrated therapies may aid in attenuating CKD progression.

Study on the relationship between blood stasis syndrome and clinical pathology in 227 patients with primary glomerular disease.

OBJECTIVE: To investigate the relationship between the severity of Chinese medicine (CM) blood stasis syndrome (BSS) with clinical features and renal lesion indexes of the primary glomerular disease. METHODS: An epidemiological survey was conducted to collect the data of 227 patients diagnosed as chronic primary glomerular diseases, and their severity of BSS were scored three days before renal biopsies were performed. The following clinical indexes were analyzed: age, course of glomerular diseases, 24-h urine protein ration (Upro), hypertension and blood pressure (BP) progress, serum creatinine levels (Scr), estimation of glomerular filtration rate based on the predigesting equation of MDRD (eGFR), blood urea nitrogen (BUN), uric acid (UA), triglyceride (TG), cholesterol (CHO), haematoglobin (HGB), albumin (ALB), and the correlation among renal pathological types, pathology lesion indexes, and BSS scores. RESULTS: (1) Among the 227 patients, 207 (91.19%) were diagnosed as BSS, in which 95 cases were considered as moderate and the rest 112 cases as severe. (2) There was a negative correlation between age, gender, grades of the hypertension, and the BSS score. Multiple stepwise regression analysis showed that Upro, CHO, TG, and eGFR were positively related to the BSS score (P<0.05). (3) The BSS score has a positive correlation with indexes of chronic renal pathology, especially the tubular atrophy and interstitial fibrosis. The severity of proliferation and glomerular sclerosis was accompanied with higher BSS scores with a significant difference (P<0.05). CONCLUSIONS: BSS is one of the most common CM syndromes among patients with the primary glomerular diseases; the BSS score has a positive correlation with Upro, CHO, TG, eGFR, as well as the index of chronic renal pathology. Based on these observations, the BSS may be used as an indicator of the development of renal diseases. Being positively diagnosed as BSS could indicate the beginning of the chronic phase of the primary glomerular diseases.

[Surrogate end points for clinical trials on chronic kidney disease and research of Chinese medicine].

Chronic kidney disease is a kind of disease with the condition always worsening over time passing through a sequence of stages, and the evaluation on its clinical treatment is mainly by observing the speed of renal function deteriorating and the time of terminal renal failure occurrence. In order to conduct the trial go on wheels, the authors proposed that the "surrogate end points (SEP)" should be introduced. It is the biologic mark for substitute the clinical terminal point (event), formed depending upon the scientific evidences of epidemiology, pathophysiology, drug-therapy and other scientific evidence, which could be used for predicting the efficacy or damage of a certain measure, present or absent. This article aimed to explain the definition of SEP and to discuss the usable SEP for clinical trial on chronic kidney disease, such as proteinuria, declination of glomerular filtration rate and its slope coefficient as well as the time of terminal occurrence. Moreover, through analyzing the existent problems in clinical researches concerning TCM treatment of chronic kidney disease, the authors suggested that some improvements, chiefly the utilization of SEP for efficacy evaluation, are necessary in the clinical observation methodologies for chronic kidney disease.