| Objective:To evaluate the curative effect of the treatment of chinese medicine combined with adefovir dipivoxil.To explore the factors affecting the curative effects,and figure out the population who are more suitable for the integrative therapy and provide evidence for appropriate introduction of Chinese medicine in clinical settings.To verify the curative effect advantages of the acquired people with advantageous curative effect in chronic hepatitis B treatment with chinese medicine combined with adefovir dipivoxil.Methods:560 cases from the national key project of the 11th-5 years plan named "the research of Chinese Medicine syndrome in CHB and the integrated medicine(the part whose ALT?2×ULN)"were brought into the research.1.To compare the improvement of TCM symptoms between two groups according to the Nimodipine law.2.To analyze the HBsAg level before and after the treatment between two groups in different populations(people of the total FAS,people with HBeAg lossing,and people with HBV DNA undetectable),and to evaluate the advantageous curative effect characteristics of the treatment of integrative medicine in reducing patients'HBsAg level.3.To analyze the level of ALT?AST?TBIL?HBeAg?HBsAg log10 and HBV DNAlog10 in baseline,as well as the rate of ALT and AST back to normal,and the rate of HBV DNA undetectable at every time point during the treatment between the people with HBeAg lost and those with HBeAg not lost.So as to explore the characteristics of curative effect measures in baseline and their changing during the treatment,which are good for HBeAg losing after the treatment.4.To analyze the influence of mother-to-child transmission,gender,and age factors to the outcomes after 48-week-treatment,such as HBeAg losing,HBeAg seroconversion,HBV DNA undetectable,and so on.So as to explore the population characteristics that can predict the treatment outcomes of integrative medicine or adefovir dipivoxil alone.5.Using the method of multiple factors analysis of Logistic regression,to analyze the affection of the factors,such as traditional Chinese medicine intervention or not,whether mother-to-child transmission,gender,age,baseline lever of ALT,HBeAg and HBV DNA,to the outcomes,including HBeAg losing,HBeAg seroconversion.HBV DNA undetectable,and complete response at time point of the 48th week.6.To compare the population with advantageous curative effects(290 cases)acquired previously with the rest population(270 cases).To analyze the outcomes,including HBeAg losing,HBeAg seroconversion,HBV DNA undetectable,and complete response at time point of the 48th week,and the changing of the curative effect measures during the treatment,including the rate of ALT and AST back to normal,HBeAg losing,HBeAg seroconversion,HBV DNA undetectable,and complete response at every time point,in the experimental group(treated with chinese medicine combined with adefovir dipivoxil)and control group(treated with adefovir dipivoxil alone)of the two populations above.So as to verify the curative effect advantages of the population with advantageous curative effects acquired previously with the treatment of chinese medicine combined with adefovir dipivoxil.Results:1.In the aspect of TCM symptoms improvement,at the 12th week,the symptoms that had a changing rate of no less than 30%in the control group were more than that in the experimental group.However,starting from the 24th week,the numbers of the symptoms that had a changing rate of no less than 30%were almost the same in both groups.At the same time,the symptoms that had a changing rate of no less than 60%began to appear at the 36th and 48th weeks,and the number of that in the experimental group was more than that in the control group(the 36th week:2 vs 1,and the 48th week:8 vs 4).2.For the people with HBV DNA undetectable at the 48th week,the rate of cases with HBsAg<250KIU/L after treatment in the experimental group was higher than that in the control group(11.00%vs 3.06%,P<0.05).3.Among both the experimental group and control group,people with HBeAg losing had a higher ALT and AST level,and a lower HBeAg,HBsAg,and HBV DNA level at baseline than people without HBeAg losing(P<0.05).Beside,people with HBeAg losing had higer rate of ALT and AST back to normal and higher rate of HBV DNA undetectable during the treatment than people without HBeAg losing.4.Among people treated with integrative medicine,people who got CHB not by the mother-to-child transmission had significantly higher rate of HBeAg losing(33.49%vs 17.91%,P<0.05),HBeAg seroconversion(23.11%vs 10.45%,P<0.05),and HBV DNA undetectable(39.15%vs 25.37%.P<0.05)than people who got CHB by the mother-to-child transmission.5.Independent factors affecting HBeAg losing are traditional Chinese medicine intervention,people who got CHB not by the mother-to-child transmission,high level of baseline ALT and low level of baseline HBeAg;independent factors affecting HBeAg seroconversion are people who got CHB not by the mother-to-child transmission and low level of baseline HBeAg;independent factors affecting HBV DNA undetectable are high level of baseline ALT,low level of baseline HBeAg and HBV DNA;independent factors affecting complete response are younger in age and low level of baseline HBeAg.6.Among the the population with advantageous curative effects,people in the experimental group had significantly higher rate of HBeAg losing(34.72%vs 8.90%,P<0.01),HBeAg seroconversion(23.61%vs 8.90%,P<0.01),HBV DNA undetectable(37.50%vs 27.61%,P<0.05),and complete response(11.81%vs 4.79%,P<0.01)than people in the control group.While among the rest population,people in the experimental group had significantly lower rate of complete response(7.35%vs 17.91%,P<0.01)than people in the control group,but the differences of the rate of HBeAg losing,HBeAg seroconversion,and HBV DNA undetectable were not significant.Conclusions:1.In the early stage of treatment,the control group had better TCM symptoms improvement than the experimental group.However,with the extension of treatment,the curative effect advantage of the experimental group appeared gradually,and the experimental group had better TCM symptoms improvement than the control group in the late stage of treatment.2.In both the experimental group and control group,HBeAg would be more likely to turn negative at the end of the treatment in patients featured with higher ALT and AST level,lower HBeAg?HBsAg?HBV DNA level at baseline,and that with ALT and AST back to normal and HBV DNA undetectable during the treatment.3.On the premise of HBV DNA undetectable,the treatment of chinese medicine combined with adefovir dipivoxil could decrease the level of HBsAg compared with the treatment of adefovir dipivoxil alone.4.People who got CHB not by the mother-to-child transmission could obtain more benefit than people who got CHB not by the mother-to-child transmission when treated with chinese medicine combined with adefovir dipivoxil.5.Traditional Chinese medicine intervention can improve the rate of HBeAg losing as an independent factor;other factors such as whether mother-to-child transmission,age,baseline lever of ALT,HBeAg and HBV DNA,may also be the important factors affecting the curative effects.6.The population with advantageous curative effects treated with chinese medicine combined with adefovir dipivoxil gained better outcomes than treated with adefovir dipivoxil alone,but this feature didn't exist in the rest population. |
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