Clinical Study Of Integrated Traditional Chinese And Western Medicine In The Treatment Of Compensated Hepatitis B Cirrhosis Based On "Liver And Spleen Related" Theory

This study is composed of two parts.The first part is the data mining of the literature on the treatment of compensated hepatitis B cirrhosis based on liver and spleen theory.The second part is the evaluation of the curative effect of Hehe Shuyang formula combined with Entecavir in the treatment of compensated hepatitis B cirrhosis.Part 1ObjectivesTo explore the rule of traditional Chinese medicine(TCM)compound for treating compensated hepatitis B cirrhosis based on relevant theory of liver and spleen.MethodsChinese literatures such as China Knowledge Resource Integrated Database(CNKI),Wanfang Data Knowledge Service Platform,and VIP Chinese Journal Service Platform(VIP)were searched from 2008 to 2019 on the literature on the TCM treatment for compensated hepatitis B cirrhosis based on related theory of liver and spleen.The database was established and the data mining method was applied to analyze the medication rule.ResultA total of 82 qualified documents were included,involving 82 prescriptions and a total of 164 Chinese herbal medicines.The single-flavored drugs commonly used in the treatment of compensated hepatitis B cirrhosis include:Bupleuri Radix,Atractylodis Macrocephalae Rhizoma,Salviae Miltiorrhizae Radix et Rhizoma,Trionycis Carapax,Astragali Radix,Angelicae Sinensis Radix and Poria.The drug category is mainly based on qi-tonifying medicinal,blood-activating and stasis-resolving medicinal and qi-regulating medicinal.Cluster analysis found that 3 kinds of compatibility rules:1.qi-tonifying medicinal is often associated with blood-activating and stasis-resolving medicinal,and a little qi-regulating medicinal;2.Soft stagnation medicine is often associated with blood-activating and stasis-resolving medicinal;3.Qi-regulating medicinal often compatible blood-activating and stasis-resolving medicinal,and a little qi-tonifying medicinal.The commonly used drug pairs and drug groups are Salviae Miltiorrhizae Radix et Rhizoma,Atractylodis Macrocephalae Rhizoma and Astragali Radix.ConclusionThe treatment of compensated hepatitis B cirrhosis based on the related theory of liver and spleen often uses qi-regulating medicinal,qi-tonifying medicinal and blood-activating and stasis-resolving medicinal,but for different stages of cirrhosis,the focus of treatment is different.Part 2ObjectivesBased on the "Liver and Spleen Related" theory,the clinical efficacy of Hehe Shuyang formula combined with Entecavir in the treatment of compensated hepatitis B cirrhosis was explored.MethodsAccording to the the inclusion and exclusion criteria,the medical records of hepatitis B cirrhosis diagnosed in the Hepatology Department of Guangdong Provincial Hospital of Chinese Medicine from January 2009 to December 2018 were screened.A total of 315 cases entered this retrospective study,and divided into treatment group and control group according to whether they were taken Hehe Shuyang formula.Collect the clinical data of the patients at week 0 and 48,including Alanine amiotransferase(ALT),Aspartate transaminase(AST),albumin(Albumin,ALB),total bilirubin(Total bilirubin,TBIL),Hepatitis B e antigen(HBeAg),Hepatitis B virus(HBV)DNA,color Doppler ultrasound,Liver stiffness measurement(LSM),Liver puncture pathology and so on.The statistical analysis method was used to analyze the data to evaluate the clinical efficacy of Hehe Shuyang formula combined with entecavir in the treatment of compensated hepatitis B cirrhosis.ResultsA total of 315 cases were included in this study.and divided into treatment group and control group according to their specific treatment plan.There were 157 cases in the control group and 158 cases in the treatment group.After examination,there were no statistically significant differences in the age,liver function,HBV DNA,LSM value,and imaging between the two groups of patients with compensated hepatitis B cirrhosis in this study(P>0.05),which are comparable.1.Liver function:The ALT,AST,ALB and TBIL in the control group and treatment group had no statistically significant difference before treatment(P>0.05),and were comparable.After 48 weeks of treatment,the differences within the groups were statistically significant(P<0.05).Compared between the two groups,the ALT and AST of the treatment group were significantly lower than that of the control group,and the ALB was significantly higher than that of the control group(P<0.05).However,there was no statistically significant difference in TBIL between the two groups after treatment(P>0.05).2.HBeAg:There were 63 HBeAg positive patients in the control group before treatment,and 73 HBeAg positive patients in the treatment group before treatment.After 48 weeks of treatment,16 HBeAg seroconversions occurred in the control group and 23 HBeAg seroconversions occurred in the treatment group.The conversion rates of the two groups were 25.4%and 31.5%.After chi-square test,χ2=0.617,P=0.432>0.05,there was no significant difference in the HBeAg conversion rates between the two groups.3.HBV DNA:The HBV DNA before treatment in the control group was 5.70±1.401g,and the HBV DNA before treatment in the treatment group was 5.82±1.361g.There was no statistical difference in HBV DNA before treatment between the two groups,which was comparable(P=0.427>0.05).After 48 weeks of treatment,the number of HBV DNA negative in the control group and the treatment group was 141 and 149.The rates of HBV DNA negative in the two groups were 93.4%and 94.9%.After chi-square test,χ2=0.326,P=0.568>0.05,there is no significant difference in HBV DNA negative rate between the two groups.4.LSM value:There was no statistically significant difference in the LSM value between the control group and the treatment group before treatment(P>0.05),which was comparable.After 48 weeks of treatment,the differences within the group were statistically significant(P<0.05).The comparison between the two groups showed that the LSM of the treatment group was significantly lower than that of the control group,the difference was statistically significant(P<0.05).5.Abdominal color Doppler ultrasound:There was no statistically significant difference in portal vein diameter and splenic thickness before treatment in the control and treatment groups(P>0.05),and they were comparable.After 48 weeks of treatment,there was no statistically significant difference between the control group before and after treatment(P>0.05),and the treatment group was statistically significant(P<0.05).Compared between the two groups,the portal vein diameter and splenic thickness of the treatment group were significantly lower than those of the control group,and the difference was statistically significant(P<0.05).6.Liver puncture pathology:A total of 16 patients underwent two hepatic punctures in the control group and a total of 14 patients underwent two hepatic punctures in the treatment group before and after treatment.After 48 weeks of treatment,both groups had improved pathology.The improvement rates of liver tissues inflammation(G)in the two groups were 56.2%and 92.0%.Tested by Fisher exact probability,P=0.039<0.05,the difference was statistically significant;the improvement rate of the degree of liver tissues fibrosis(S)of the two groups were 50.0%and 85.7%,Tested by Fisher exact probability,P=0.058>0.05,Difference is of critical statistical significance.Conclusion1.Hehe Shuyang formula can improve patients’ ALT,AST,ALB,TBIL,LSM,portal vein diameter,splenic thickness,liver tissues inflammation,has the effect of protecting liver and anti-fibrosis,and is an effective medicine for improving the curative effect of compensated hepatitis B cirrhosis.2.Compared with entecavir alone,under the guidance of the "Liver and Spleen Related" theory,the combination of Hehe Shuyang formula and entecavir has advantages in protecting liver and resisting liver fibrosis.