KMCRIC

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.

Li S, Rao XR, Dai XW, Pei K, Wang L, Huo BM, Wang XJ, Kong LX, Zhang NN, Lian FM.

Medicine (Baltimore).

2017

96(28)

e7448.

10.1097/MD.0000000000007448.

28700482

http://www.ncbi.nlm.nih.gov/pubmed/28700482

Administration, Oral
Biomarkers/metabolism
Comorbidity
Creatinine/blood
Disease Progression
Double-Blind Method
Drug Therapy, Combination
Drugs, Chinese Herbal/administration & dosage*
Drugs, Chinese Herbal/adverse effects
Female
Follow-Up Studies
Glomerular Filtration Rate/drug effects
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Multivariate Analysis
Phytotherapy*/adverse effects
Proportional Hazards Models
Renal Insufficiency, Chronic/drug therapy*
Renal Insufficiency, Chronic/metabolism
Renal Insufficiency, Chronic/mortality
Severity of Illness Index
Treatment Outcome

chronic kidney disease (stage 3–4); complementary therapies; eGFR-Slope; Fu-Zheng-Qu-Zhuo oral liquid; randomized placebo-controlled clinical trial

만성 신장 질환 (3-4기); 보완대체요법; 사구체 여과율 추정 경사도; 부정거탁 내복액; 무작위 위약 대조 임상시험

없음

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?±?9.6months. The FZQZ group had amean eGFR-Slope of 0.25?±?1.44 as compared with -0.72?±?1.46 (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.

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