A Real-world Study Of The Effects Of TCM Syndrome Differentiation Combined With Antiviral Therapy On The Incidence Of Cirrhosis In Patients With Chronic Hepatitis B

Objective:Based on the concept of real world study,this study aims to evaluate the impact of TCM syndrome differentiation combined with antiviral therapy on the incidence of cirrhosis in patients with chronic hepatitis b and explore the relevant influencing factors of cirrhosis in patients with chronic hepatitis B.Method:A retrospective cohort study,participants included 521 cases of chronic hepatitis b patients,according to the different degree of TCM syndrome differentiation treatment is divided into traditional Chinese and western medicine combined with queue queue 260 cases,261 cases and western medicine on two queue incidence of hepatitis b cirrhosis of the liver,HBV-DNA Yin turn rate,HBeAg serological conversion rate,rate of HB sAg Yin turn,anti-HBs Yang turn rate and liver function(TBiL,ALT,AST,propagated after constant rate),and hepatitis b cirrhosis of the liver tissue pathology of related risk factors analysis,To explore the effect of long-term Chinese medicine treatment on delaying hepatitis b cirrhosis.Result:1.The median follow-up time was 8 years in both the integrated Chinese and western medicine cohort and the western medicine cohort.The cumulative incidence of cirrhosis was 6.5%vs.11.9%in the two cohorts after 5 years of treatment,6.5%vs.13.5%after 7 years of treatment,and 6.9%vs.13.5%after 10 years of treatment,with statistically significant differences between the two cohorts(P<0.05).At the end of follow-up,18 patients in the integrated Chinese and western medicine cohort developed cirrhosis,and 35 patients in the western medicine cohort developed cirrhosis.The overall cirrhosis incidence rate of the two cohorts was 6.9%vs.13.5%,with statistical difference(P=0.013).2.At 0.5 years of treatment,the negative conversion rate of HBV DNA in the integrated Chinese and western medicine cohort and the western medicine cohort was 64.4%vs.55.76%,with statistical difference(P<0.05),while at 1,2,3,5,7 and 10 years of treatment,there was no significant difference between the two cohorts(P>0.05).The incidence of drug resistance in the integrated Chinese and western medicine cohort and the western medicine cohort was 8.81%vs.19.62%,with statistically significant difference(P<0.05).HBeAg serological conversion rate was 33.48%vs 24.43%in the western medicine combination cohort and western medicine cohort after 5 years of treatment,and 39.16%vs 24.28%after 7 years of treatment,with statistical difference(P<0.05).At the end of follow-up,the negative conversion rate of HBsAg in the integrated Chinese and western medicine cohort and the western medicine cohort was 10.73%vs.6.54%,but the statistical comparison showed no significant difference(P>0.05).The positive rate of anti-hbs in the integrated Chinese and western medicine cohort and the western medicine cohort was 5.7%vs.3.5%,and the statistical comparison showed no significant difference(P>0.05).3.At 3 years of treatment,the ALT recurrence rates in the integrated Chinese and western medicine cohort and the western medicine cohort were 90.04%vs.80.77%,with statistical difference(P<0.05).There was no statistical difference in the ALT recurrence rates between the two cohorts at 5,7 and 10 years of treatment(P>0.05).At 3 years and 10 years of treatment,the AST recurrence rates of the integrated Chinese and western medicine cohort and the western medicine cohort were 86.9%vs.77.3%and 93.24%vs.81.2%,respectively,with significant differences(P<0.05).At 5 years and 7 years of treatment,there was no statistical difference in AST recurrence rates between the two groups(P>0.05).At 3 and 5 years of treatment,the ALB normal rate in the integrated Chinese and western medicine cohort was 96.93%vs 90%,98.21%vs 94.6%,with significant difference(P<0.05).At 7 and 10 years of treatment,there was no statistical difference in the ALB normal rate between the two groups(P>0.05).4.A total of 38 patients completed liver biopsy before and after treatment,including 20 patients in the integrated Chinese and western medicine cohort and 18 patients in the western medicine cohort.After treatment,the total improvement rate of fibrosis stage in the integrated Chinese and western medicine cohort and the western medicine cohort was 45%vs.11.11%,with statistical difference(P<0.05).5.The overall effective rate of TCM syndromes in the integrated Chinese and western medicine cohort and the western medicine cohort was 95.4%vs.83.1%(P<0.05);There were statistically significant differences in TCM syndrome score between the integrated Chinese and western medicine cohort and the western medicine cohort in 3,5,7 and 10 years of treatment(P<0.05).6.Univariate analysis of cirrhosis incidence based on baseline data showed that the incidence of cirrhosis in males was higher than that in females(P=0.03 8),and the incidence of cirrhosis in patients aged 40 years was higher than that in patients aged<40 years(P=0.012).The incidence of liver cirrhosis in patients with HBV infection course of 10-15 years was higher than that in patients with 0-5 years(P=0.007),and the incidence of liver cirrhosis in patients with HBV infection course of 15-15 years was higher than that in patients with 0-5 years(P=0.001).The incidence of cirrhosis in hbeag-positive patients was higher than that in hbeag-negative patients before treatment(P=0.04).The incidence of cirrhosis in patients with HBV DNA 107 before treatment was higher than that in patients with HBV DNA 103 before treatment(P=0.036).The incidence of cirrhosis in patients with a family history of HBV infection was higher than that in patients without a family history of HBV infection(P=0.022),and the incidence of cirrhosis in patients with a history of alcohol consumption was higher than that in patients without a history of alcohol consumption(P=0.000).There was no significant difference in the incidence of cirrhosis between different ALT levels(P=0.542).There was no significant difference in the incidence of cirrhosis between different syndromes(P=0.653).7.Multivariate analysis of Cox proportional risk regression model showed that male(95%ci:0.080-0.917,P=0.031),age 40 years old(95%ci:1.001-1.050,P=0.040),family history of HBV infection(95%ci:1.335-4.327,P=0.006),drinking history(95%ci:2.477-11.174,P=0.000),HBV DNA quantitative 107(P<0.05),and HBeAg positive(95%ci:1.032-4.563,P=0.041)is an independent risk factor for the occurrence of hepatitis b cirrhosis,while TCM treatment based on syndrome differentiation is a protective factor for delaying the occurrence of hepatitis b cirrhosis.8.During the long-term treatment with TCM syndrome differentiation,the renal function,blood routine,urine routine,electrocardiogram and other indicators of the patient were dynamically monitored,and the results indicated that the patient did not suffer from aggravation or deterioration of the disease or adverse events caused by TCM during the long-term treatment with TCM syndrome differentiation.9.According to the analysis of drug frequency,the traditional Chinese medicines with a cumulative use frequency of more than 30%include Fried atractylodes atractylodes,rhizoma atractylodis,rhizoma corydalis,Yin Chen,tuckahoe,Fried pittospori,junxue,cuttlefish bone and pinellia ternata.The statistical results showed that cold drugs were the main drug,warm drugs and mild drugs were the second,cold and hot drugs were the least frequently used,and hot drugs were the least frequently used.The results showed that bitter and sweet drugs were the main drugs,and bitter drugs were the second.The drugs belong to the liver meridian of the foot jueyin,followed by the stomach meridian of the foot yangming,the spleen meridian of the foot taiyin,the lung meridian of the hand taiyin and the kidney meridian of the foot shaoyin.Conclusion:1.Long-term TCM syndrome differentiation combined with antiviral therapy for chronic hepatitis b can reduce the incidence of hepatitis b cirrhosis.2.The combined treatment of traditional Chinese and western medicine can relatively improve the virological response rate,HBeAg serological conversion rate and ALT recurrence rate,significantly improve the clinical symptoms of traditional Chinese medicine,liver histology and imaging of patients,and the treatment safety is good.3.Multivariate analysis showed that baseline male,age 40 years old,hbv-related family history,drinking history,HBeAg positive,HBV DNA quantitative 107 were risk factors for cirrhosis of chronic hepatitis b.4.Professor Chen jianjie,the tutor,advocates the treatment of chronic hepatitis b from the perspective of "dampness" and emphasizes the treatment principle of "clearing away heat and dampness and caring for zhongzhou".At the same time,he believes that"harmony" should be given priority to,combining attack and compensation,not forgetting the syndrome,paying attention to the dosage of drugs,and using drugs peacefully and lightly.5.The real world study conforms to the actual clinical situation of TCM,and can provide some scientific basis for the evaluation of clinical efficacy of TCM syndrome differentiation.