Lamivudine Combined With Traditional Chinese Medicine Treatment Of Chronic Hepatitis B Clinical Research

Objective:To Study the efficacy of Lamivudine combined with Double TigersClearing away Liver-fire Granule and YiGanYiQiJieYu Powder in treating chronic hepatitis B.and to make the clinic effectiveness assessment of Tradiional Chinese Medidne.Methods:This was a multi-center, randomized (1:1), double-blinded and controlledclinic trial. 278 patients of chronic hepatitis B. whose serum HBV-DNA and HBeAg arepositive were dividing into two groups randomly. The treated group included 140 cases whilethe controlled group had 138 cases. The therapeutic group were treated with Lamivudineorally 100mg once daily combined with YiGanYiQiJieYu Powder orally 10mg tid. andDouble Tigers Clearing away Liver-fire Granule 10mg tid. once daily, while the control groupwere treated with Lamivudine orally 100mg once daily only. 48 weeks regarded as onetreatment course,The Liver function,Marking thing of hepatitis B,HBV-DNA. Theimmunology index. The traditional Chinese medicine symptoms and syndromemanifestations. The quality of life(QOL) and the chronic liver disease questionnaire weremeasured respectively at baseline, 12 weeks, 24 weeks, 36 weeks and 48 weeks.Results:1. Serological response: After 24 weeks,the turning negative rate of HBeAgin the therapeutic group was 28.3%, not higher than that in control group which was27.1%(P>0.05).The turning rate of HBeAg/anti-HBe in the therapeutic group was 20.8%, nothigher than that in control group which was 20.3%(P>0.05). After 48 weeks,the turningnegative rate of HBeAg in the therapeutic group was 27.1%, obviously higher than that incontrol group which was 16.7%(P=0.034)(PP). The turning rate of HBeAg/anti-HBe in thetherapeutic group was 28.0%, higher than that in control group which was17.7%(P=0.087)(PP).2. Virological response: After 24 weeks,the complete response rate of the therapeuticgroup was 75.5%, partial response rate was 11.2%, non-response rate was 13.3%, the controlgroup was respectively 68.8%,13.5% and 17.7%, there had no different between twogroups(P=0.288). After 48 weeks,the complete response rate of the therapeutic group was57.1%, partial response rate was 18.6%, non-response rate was 24.3%, the control group wasrespectively 55.8%,18.2% and 26.0%. there had no different between two groups(P=0.842).The turning negative rate of HBV-DNA of the therapeutic group was higher than the controlgroup that was 75.5% vs 68.8% (P=0.288) at week 24 and .57.1% vs 55.8% (P=0.842) atweek 48.3. Biochemical response:The ALT normalization rate of the therapeutic group wasrespectively53.8%,73.0%,80.7% and 69.1% at 12wk,24wk,36wk and 48wk, while the controlgroup was 54.2%,66.7%,64.8% and 67.9%, The normalization rate of the therapeutic group in6 and 9 month is significantly high than the control group, especially at 36wk, there had significant difference between two groups(p=0.017).4. Combined response: After 24 weeks,the complete response rate of the therapeuticgroup was 12.8%, partial response rate was 80.0%, non-response rate was 6.4%, the controlgroup was respectively 12.8%,78.2% and 9.0%, there had no different between twogroups(P>0.05). After 48 weeks,the complete response rate of the therapeutic group was6.0%, partial response rate was 86.5%, non-response rate was 7.5%, the control group wasrespectively 5.2%,84.4% and 10.4%. there had no different between two groups (P>0.05).5. Immunologic indexes: before treatment, after 24 and 48 weeks,the normal/abnormalmembers of CD3+,CD4+,CD8+ had no signature different(p>0.05).The proportion of CD3+,CD4+,CD8+,CD4+/CD8+ between two groups had no significant difference (p>0.05). TheCD4+ level of the two groups had significantly lower than itself before treatment,but therehad no significant differency between two groups (P=0.721).6. TCM symptoms: After 48 weeks,there had a significant difference on integration ofrestless tantrum and indentation tongue (P=0.027和P=0.043),the disappeared numbers ofthis two symptoms in the therapeutic group was more than the control group,Thedisappearance rate is 81% vs 68%和61% vs 47%。The rest symptoms had not statisticallysignificant (P>0.05).The therapeutic group had a higherly disappearance rate on thesymptoms such as bitter taste of mouth , poor appetite ,stool loose, restless tantrum andwakeful than the control group,while the control group is higher in gastric cavity full andinactive, sick than the treatment group.The consequence showed that the therapeutic groupsurpassed the lamivudine group in improving the hepatochlic hygropyrexia and stagnation ofliver-QI with deficiency of the spleen symptoms.7. TCM syndrome manifestations: There had no significant difference on the syndromeintegration between two groups at 12wks,24wks,36wks and 48wks. The syndromeintegration of two groups were more lower on the syndrome integration than itself beforetreatment.8. WHOQOL-BREF:There had no different between two groups in total quality of lifeand total healthy level,and in physical, psychology, social, environmental domain at 0week,24week, 36week,48 week (p>0.05).Excerpt the psychology and social domain had nosignificant difference ,the other domains are all higher than itself at 0 week (p<0.05 or p<0.01)in the therapeutic group. The control group in all domains are higher than itself at 0 week(p<0.05 or p<0.01) excerpt the social domain.9. CLDQ: There had no different between two groups on tiredness degree, energy,affection, abdominal symptom, system symptom and anxiety degree (p>0.05) at 0week,24weeks, 36weeks and 48weeks. The integration of two groups were more lower on thesyndrome indentation than itself before treatment.Conclusion:The combination treatment with Lamivudine combined with DoubleTigers Clearing away Liver-fire Granule and YiGanYiQiJieYu Powder on chronic hepatitis B is superiorior to using Lamivudine only on the aspect of strengthening antivirus, antiinflammatory ,protecting liver ,lowering enzyme and improving part clinic symptoms.