Risk Factor Analysis Of Exacerbation Of Chronic Hepatitis B Patients And Multi-center Clinical Study On The Intervention Of Jiedu Huayu Granules

Objective: To study the clinical outcome of Jiedu Huayu Granules to the exacerbation of chronic hepatitis B patients,and to study the risk factor progressing to acute on chronic liver failure in patients with severe exacerbation tendency of chronic hepatitis B.Methods:1.Clinical observation: 200 patients with severe exacerbation tendency of chronic hepatitis B were included in this study and were divided into two groups according to the Clinical evaluation center of Chinese academy of Chinese medical sciences—Central random system.Due to 10 were lost,evevtually there were 95 cases in the treatment group and 95 in the control group.The control group was treated with western medicine,and the treatment group was treated Jiedu Huayu Granules under the western medicine,Continuous treatment for 4 weeks,followed up for 12 weeks.Observing the results of liver function(TBi L,ALB,ALT,AST),renal work(Cr,BUN),coagulation function(PT,PTA,INR),HBV-DNA level,MELD score and clinical outcome before and after the treatment.2.Risk factor Analysis: 190 patients were divided into two groups according to the clinical outcome,11 cases in the liver failure group,179 cases in the improvement group.Through analyzing the differences between the two groups of gender,age,nationality,antivirus history,baseline HBV DNA level,MELD score,TBi L,DBi L,ALT,ALB,Cr,BUN,PT,PTA and INR,to find the risk factor progressing to acute on chronic liver failure in patients with severe exacerbation tendency of chronic hepatitis B.Results:1.Clinical observation: In the level of liver function,the level of ALT,AST,TBi L,DBi L in both two groups were improved compared with before treatment,the difference was statistically significant(P<0.05).The level of ALB in both two groups were increased in 1w(P<0.05).Compared with the control group,the level of ALT,AST,TBi L,DBi L were decreased significantly than the treatment group,the difference was statistically significant(P<0.05).In the coagulation function: the level of PT,INR,PTA in both two groups were improved in 4w and 12 w compared with before treatment,the difference was statistically significant(P<0.05).Compared with the control group,the level of PT,PTA,INR were improved significantly than the treatment group,the difference was statistically significant(P < 0.05).In the MELD scores: the level of MELD scores in both two groups were decreased in 4w and 12 w compared with before treatment,the difference was statistically significant(P<0.05).Compared with the control group,the level of MELD scores were decreased significantly in 4w and 12 w than the treatment group,the difference was statistically significant(P<0.05).In the clinical outcomes: after 4 weeks treatment and 12 weeks follow-up visit,there were 8 cases who progressed into liver failure in the control group(8.43%),and 3 cases in the treatment group(3.16%),the occurrence rate of liver failure was lower in the treatment group,the difference was statistically significant(P<0.05).2.Risk factor Analysis: Univariate risk of progressing to acute on chronic liver failure in patients with severe exacerbation tendency of chronic hepatitis B were age?45,HBV DNA?105IU/ml,MELD scores,TBi L,PT,PTA and INR.Logistic regression analysis showed that TBi L and PT are the independent risk factors associated with the development of ACLF.The ROC curve was drawn,and the area under the ROC curve of TBi L was 0.907,and the 95% confidence interval was(0.840,0.974).The area under the ROC curve of PT is 0.866,and the 95% confidence interval is(0.794,0.938).According to the area under the ROC curve,the diagnostic value of TBi L is relatively high,and the diagnostic value of DBIL,INR,PT and MELD is moderate,and the value of virus and age is low.Conclusion1.Jiedu Huayu granules can improve the severe exacerbation tendency of chronic hepatitis B patients' clinical symptoms and signs,decrease the liver damage,reduce the MELD scores,lower the mortality,and no side effects and the incidence of adverse events,safe and reliable,has the value of clinical promotion.2.Univariate risk of progressing to acute on chronic liver failure in patients with severe exacerbation tendency of chronic hepatitis B were age?45,HBV DNA?105IU/ml,MELD scores,TBi L,PT,PTA and INR.TBi L and PT are the independent risk factors associated with the development of liver failure.