Clinical Evaluation Of Qian Yang Ruan Gan Decoction On The Treatment Of Compensated Hepatitis B Virus-related Cirrhosis

Research Purpose:To observe the improvement of liver stiffness measurement value,portal vein diameter and clinical symptoms and signs in the patients with compensated hepatitis B virus-related cirrhosis treated by Qian Yang Ruan Gan decoction and objectively evaluate the curative effect and safety of the decoction on compensated HBV-related cirrhosis.Objects and methods:From Jan 1,2018 to Dec 12,2019,51 patients in Affiliated Hospital of Chengdu University Of Traditional Chinese Medicine(Si Chuan Provincial Hospital of TCM)were selected in strict accordance with inclusion and exclusion criteria for screening and were randomized into two groups with 26 patients in test group and 25 in control group.In this three-courses(totally 90days)trial,patients in control group were received enticavir monotherapy while patients in test group,on the basis of control group,were received Qian Yang Ruan Gan decoction.Curative effect indices included liver stiffness measurement(LSM)value through Transient Elastography,portal vein diameter(PVD)measured via ultrasonography,Child-pugh score and TCM syndrome score.Safety indices included incidence rate of adverse events,liver function indices,hepatitis B virus-DNA and Estimates of Glomerular Filtration Rate(e GFR).For every patients,all curative effect indices,HBV-DNA and e GFR were tested and TCM syndrome scores were calculated before and after treatment.Liver function indices were tested before treatment and after every treatment course.All datum taken from above were recorded.Statistical analysis have been proceed on SPSS ver23.0.T test was used to compare the measurement datum between two groups.Rank sum test was used to compare the therapeutic effect of two groups and chi-square test the counting data between two groups.Correlation was analyzed with Pearson correlation coefficient.Results:LSM value:Both the test group and the control group had curative effect on reducing LSM value(p<0.05)and the test group had shown more effective(p<0.05).Portal vein diameter:Both the test group and the control group could reduce PVD(p<0.05)while there is no statistical difference between the two groups(p>0.05).Child-pugh socre: both the two groups had shown no effect on reducing Child-pugh socres(p > 0.05).Therapeutic effect based on TCM syndrome score:the total effective rate of the test group was 88%,and that of the control group was 56%indicating that the difference of clinical curative effect between the two groups according to TCM syndrome was statistically significant.Better curative effect was attained in test group(p < 0.05).Correlation analysis:There is linear positive correlation between LSM value and PVD after treatment in test group(r=0.460)which indicated that the reduction of PVD could be profit from the reduction of LSM value.Safety evaluation:Incidence rate of adverse events in the test group and control group was respectively 19% and 4%,between which the difference was of no statistical significance(p>0.05).Liver function:Both the two groups showed no effect on serum ALT,AST and TBIL level(p>0.05)and there was no statistical difference between the two groups(p > 0.05).Renal function evaluation:Both the two groups showed no effect on e GFR(p>0.05)and there was no statistical difference between the two groups(p>0.05).Conclusion:(1)For patients with compensated HBV-related cirrhosis,both the Qian Yang Ruan Gan decoction and enticavir could,to some extent,reduce the LSM value and are capable of assuaging some clinical symptoms.Combined therapy have presented better curative effect than enticavir monotherapy indicating that the Qian Yang Ruan Gan decoction is of anti-fibrosis effect.(2)Both the Qian Yang Ruan Gan decoction combined with enticavir could reduce PVD,which is not different with enticavir monotherapy,but the reduction of LSM value contributes to that of PVD.Thus the combined therapy could be considered more effective.(3)There are low incidence rate of AEs in the use of Qian Yang Ruan Gan decoction.The symptoms were mild and gradually disappeared as the trial continuing.It have shown no effect on patient`s liver function and renal function。Qian Yang Ruan Gan decoction practicing on patients with compensated HBV-related cirrhosis have demonstrated curative effect and safety,however,its long-term curative effect remains to be verified.