Clinical Observation On The Treatment Of Chronic Hbv Infection In The Period Of Immune Tolerance (Spleen And Kidney Deficiency Syndrome)

OBJECTIVE: To comprehensively evaluate the treatment of immune tolerance by optimizing the kidney and strengthening the spleen by observing the effects of TCM syndromes,liver function(ALT,AST),HBV DNA,HBs Ag,HBe Ag,and LSM in patients with chronic HBV infection in the immune tolerance stage The clinical efficacy of patients in the early stage provides a more effective,safe and accurate clinical basis for the clinical application of this method.Methods: Using a randomized,placebo-controlled trial design method,60 subjects were randomly assigned to the experimental group and the control group at a ratio of 1:1,with 30 cases in each group.Patients in the experimental group took the optimized prescription of Bushen Jianpi Decoction,and the patients in the control group took placebo with traditional Chinese medicine,1packet/time,2 times/d,for 36 weeks.After treatment,observe the TCM syndrome curative effect,serum HBV DNA quantification,HBs Ag,HBe Ag,liver function(ALT,AST),LSM level changes of the two groups of patients.Result:(1)TCM syndrome scores: After 36 weeks of treatment,the total scores of TCM syndromes in both groups were lower than before,and the comparison before and after treatment was statistically significant(P<0.05);comparison between groups showed that the total scores of TCM symptoms in the experimental group Lower than the control group,statistically significant(P<0.05).After 36 weeks of treatment,comparing the individual symptom scores of traditional Chinese medicine,the scores of hypochondriac pain and fatigue symptoms were significantly lower than those of the control group,which was statistically significant(P<0.05);the experimental group and the control group were affected by chills,soreness of waist and knees,Comparing the scores of six TCM individual symptoms of dull complexion,poor appetite,complete grain failure,and clear urination,the difference was not statistically significant(P>0.05).(2)Efficacy of TCM syndromes: After 36 weeks of treatment,the total effective rate of the experimental group was 86.6 7%;the total effective rate of the control group was 53.33%.The comparison of the efficacy of TCM syndromes between the two groups was statistically significant(P<0.05).(3)HBs Ag: comparison within the group,the experimental group was compared with 0 week after 24 weeks and 36 weeks of treatment,the difference was statistically significant(P<0.05),the control group was compared with 0week after 24 weeks and 36 weeks of treatment respectively,The difference was not statistically significant(P>0.05).In comparison between groups,the difference between the experimental group and the control group at the same period of 24 weeks and 36 weeks was statistically significant(P<0.05).(4)HBe Ag: After 24 weeks and 36 weeks of treatment,the HBe Ag levels of the two groups were compared.At the same time,the experimental group was significantly lower than the control group,which was statistically significant(P<0.05).In the experimental group,the 24 th and 36 th weeks after treatment were compared with 0 weeks respectively,which was statistically significant(P<0.05).In the control group,there was no statistical significance(P>0.05)compared with week 0 after the 24 th and 36 th weeks of treatment.(5)HBV DNA: After 24 weeks and 36 weeks of treatment,the HBV DNA levels of the two groups of patients were compared.At the same time,the experimental group was significantly lower than the control group,which was statistically significant(P<0.05).In the experimental group,the intra-group comparison(P<0.05)was statistically significant.In the control group,the intra-group comparison(P>0.05)was not statistically significant.(6)HBV DNA decline and negative conversion: After 24 weeks and 36 weeks of treatment,the number of HBV DNA declines greater than 1 lg was statistically significant in comparison between the experimental group and the control group at the same time(P<0.05).After 36 weeks of treatment,the number of HBV DNA decreased by more than 2 lg was statistically significant between the two groups(P<0.05).For the comparison of the number of HBV DNA decline greater than 3 lg and the number of negative cases,the comparison between the two groups at the same time period was not statistically significant(P>0.05).(7)ALT,AST: After ALT and AST were treated for 24 and 36 weeks,there was no statistical difference between the same period of time(P>0.05);there was no statistical difference between the two groups at 24 and 36 weeks and the 0 week group(P>0.05).(8)LSM value: 24 weeks,36 weeks,the experimental group was compared with the control group at the same time period,both were statistically significant(P<0.05).Comparison within the group,the experimental group was treated at 24 weeks and 36 weeks,compared with 0 weeks(P<0.05),both were statistically significant;at 24 and 36 weeks in the control group,compared with0 weeks,there was no Statistical significance(P>0.05).Conclusion: Bushen Jianpi optimization prescription can relieve the clinical symptoms of patients in the immune tolerance stage of chronic HBV infection,reduce HBs Ag and HBe Ag levels to a certain extent,inhibit the replication of HBV DNA,and reduce the LSM value.It is effective for patients in the immune tolerance stage of chronic HBV infection.Intervention effect.During the course of treatment,the patient had no adverse reactions,and no abnormal changes in the monitoring safety indicators showed that the Optimal Formula for Nourishing Kidney and Spleen is safe.