| ObjectiveAnalyzing the efficacy of Chinese medicine combined with entecavir in the treatment of HBeAg-positive chronic hepatitis B for 108 weeks,evaluating its influencing factors and analyzing the outcome of different drug programs,the aim is to improve the clinical efficacy and provide some predictable results for the clinical outcome.MethodsIn this study,596 cases were brought into the research named "Study on Treatment Scheme of HBeAg Positive Chronic Hepatitis B Combined with Chinese Medicine and Western Medicine" from the "Twelfth Five-Year Plan" of National Science and Technology Major Project.1.Logistic regression was used to analyze the effect of Chinese medicine intervention or not,age,sex,mother-to-child transmission,baseline ALT,baseline AST,HBeAg and HBV DNA at baseline,12 weeks and 24 weeks and HBeAg and HBV DNA changes from baseline to 12th and 24th week on the HBeAg loss in different drug programs.The independent predictors related to the outcome were selected and the logistic regression model was established.The ROC curve were used to evaluate the the predictive value of the predictors and logistic regression model,thus the predictive ability of the predictive factors and models were established.2.The age,sex,mother-to-child transmission,HBeAg,HBV DNA,ALT and AST were analyzed by chi-square test,rank-test or T-test to analyze the baseline in different drug programs.The changes of HBeAg and HBV DNA in the Chinese medicine intervention group and the control group were analyzed in different drug programs at each time point during the treatment.3.The chi-square test was used to compare the difference of HBeAg negative rate and HBV DNA negative rate between the Chinese medicine intervention group and the control group at 108th week in different drug programs.Results1.The influencing factors of 108th week’s outcome was screened out by logistic regression analysis.The A-A drug program’s independent predictors of HBeAg negative were Chinese medicine intervention,and the baseline ALT and the drop of 24-week HBV DNA from the baseline level.The above factors and the predicted model were predictive of HBeAg negative for 108 weeks.The A-B drug program’s independent predictors of HBeAg negative were age,24-week HBeAg levels.The above factors and the predicted model of its construction have predictive value of HBeAg negative for 108 weeks.The B-B drug program’s independent predictor of HBeAg negative was Chinese medicine intervention.The predicted model of Chinese medicine intervention and joint factor construction have predictive value of HBeAg negative for 108 weeks.F A-A and A-B drug program,the predictive value of multi-factor joint predicted model is better than single factor.2.In the A-A drug program,the level of HBeAg and HBV DNA in the control group was decreased rapidly during the treatment of 0-24 weeks,and after the 24-week test group was changed the treatment program,the level of HBeAg and HBV DNA in the test group was decreased rapidly.36-108 weeks,the level of HBeAg and HBV DNA in both groups was decreased slowly.In the A-B drug program,the levels of HBeAg and HBV DNA in the two groups were decreased rapidly during the treatment of 0-12 weeks.The test group continued to decrease at a faster rate during 12-24 weeks,and the two groups decreased slowly after 24 weeks.In the B-B drug program,the levels of HBeAg and HBV DNA in the two groups were decreased rapidly during the treatment of 0-12 weeks,and decreased slowly during the 12-108 weeks.3.In the A-A drug program,when treated to 108 weeks,the negative rate of HBeAg in the test group was higher than that in the control group(P<0.05).The negative rate of HBV DNA in the test group was higher than that in the control group when treated to 108 weeks,but the difference was not statistically significant(P>0.05).In the A-B drug program,the negative rate of HBeAg was 41.49%and 37.61%in the test group and the control group at the time of 108th week,but the difference was not statistically significant(P>0.05).The negative rate of HBV DNA was 90.43%and 94.02%in the test group and the control group,the control group was higher than the test group,but the difference was not statistically significant(P>0.05).In the B-B drug program,the negative rate of HBeAg was 48.72%and 30.38%in the test group and the control group at the time of 108th week,the negative rate of HBeAg in the test group was higher than that in the control group(P<0.05).The negative rate of HBV DNA was 88.46%and 83.54%in the test group and the control group,but the difference was not statistically significant(P>0.05).Conclusions1.The influencing factors of 108th week’s outcome was screened out by logistic regression analysis.For the A-A drug program,the addition of Chinese medicine can significantly improve the HBeAg negative rate,the higher the baseline ALT level,the better the efficacy,and the higher the level of HBV DNA at 24th week compared with baseline,the better the efficacy.For the A-B drug program,the younger the age and the lower the HBeAg level at 24th week,the HBeAg negative rate would higher.For the B-B drug program,adding Chinese medicine can significantly improve the HBeAg negative rate.The predictive value of multi-factor joint predicted model was better than single factor.2.The 108th week’s outcome of different drug programs:①The HBeAg negative rate of the test group was significantly higher than that of the control group in the A-A drug program and the B-B drug program for 108 weeks;②For the A-B drug program,patients with high level of HBeAg before enrollment,if during 0-24 weeks ALT rised or HBeAg was decreased,both test group and control group had good effects;③For the A-A drug program.patients with high level of HBeAg before enrollment,if 0-24 weeks does not appear the above situation,the outcome of test group is better than control group;④For the B-B drug program,patients with low level of HBeAg before enrollment,test group is superior to control group. |
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