Fuzheng-Huayu (FZHY) formula has been found to have a satisfactory effect on hepatitis B-caused cirrhosis (HBC) treatment. However, the efficacy evaluation of FZHY is often challenging. In this study, a randomized, double-blind and placebo-controlled trial was used to evaluate the therapeutic efficacy of FZHY in HBC treatment. In the trial, 35 medical indexes were detected, and 14 indexes had a statistically-significant difference before compared to after the trial. Importantly, the Child-Pugh score also demonstrated FZHY having therapeutic efficacy. Furthermore, the microRNA (miRNA) profiles of 12 serum samples were detected in FZHY groups, and 112 differential-expressed (DE) miRNAs were determined. Using predicted miRNA targets, 13 kernel miRNAs were identified from the established miRNA-target network. Subsequently, quantitative Real-time Polymerase Chain Reaction (qRT-PCR) was used to validate the expression level of 13 identified miRNAs in the trials. The results showed that nine miRNAs have a statistically-significant difference before compared to after FZHY treatment. By means of a logistic regression model, a miRNA panel with hsa-miR-18a-5p, -326, -1182 and -193b-5p was established, and it can clearly improve the accuracy of the efficacy evaluation of FZHY. This study suggested that the particular miRNAs can act as potential biomarkers and obviously increase the diagnostic accuracy for drug evaluation in HBC treatment progression.
[1]Shanghai Univ Tradit Chinese Med, Res Ctr Tradit Chinese Med Complex Syst, Shanghai 201203, Peoples R China.
[2]Fudan Univ, Inst Biomed Sci, Lab Epigenet, Shanghai 200032, Peoples R China.
[3]Shanghai Jiao Tong Univ, Shanghai Peoples Hosp 1, Dept Endocrinol & Metab, Shanghai 201201, Peoples R China.
[4]Shanghai Univ Tradit Chinese Med, Inst Liver Dis, Shanghai 201203, Peoples R China.
[5]Shanghai Univ Tradit Chinese Med, Shuguang Hosp, Shanghai 201203, Peoples R China.
(8.0+极速模式)