| Objective: To observe the curative effect of Yiqij iedu method comined with entecavir in HBe Ag positive CHB treatment, and to reveal TCM syndrome essence with Qi deficiency and toxin accumulation.To provide an objective basis for the clinical application of Yiqi Jiedu method and to explore new method of improving of antiviral therapeutic effect for this disease.Methods: 50 patients based on the inclusion and exclusion criteria were divided into the treatment group(25 cases) and control group(25 cases).The control group were in accordance with the former treatment(entecavir 0.5 mg p.o qd), the treatment group were added with Yiqi Jiedu Chinese patent medicines(bezoar ginseng capsule 3 times a day, 2 capsules each time) combined with entecavir, two groups were treated for 24 weeks. The primary observation points included symptoms of TCM treatment, HBV markers accurate quantitation and HBV DNA quantification and lymphocyte subsets in classification and so on, and compared two groups of curative effect and analysed Yiqi Jiedu on HBe Ag positive chronic hepatitis B patients with viral serology and lymphocytes.Results: TCM syndrome total scores comparison: the total scores in treatment group and control group were 3.82 ± 1.05,5.62 ± 1.01 respectively after treatment, significantly lower than the control group(P<0.05). Every main TCM syndrome scores comparison: every main TCM syndrome scores of treatment group were significantly lower compared with before(P < 0.05),Shenpi fatigue, loss of appetite,loose stool in the control group compared with before(P<0.05).Shenpi fatigue, less gas lazy words, abdominal distension nausea, loss of appetite,dry mouth were significant difference(P<0.05), the treatment group was better than control group. Liver function and HBV DNA quantitative:liver function were normal and HBV DNA load were lower than the lowest limit of detection in the case of the study, there were no significant changes before and after treatment(P>0.05). E antigen serological conversion rate comparison:the treatment group was 8%, the control group was 0%, P>0.05, there was no significant difference. HBe Ag titer comparison: HBe Ag titers in treatment group were significantly lower than those of before(P<0.05) after treatment, the control group had no significant change(P>0.05); there was no significant difference between the two groups(P>0.05). HBs Ag titer comparison: HBs Ag titers in the treatment group were significantly lower than those of before(P<0.05) after treatment, the control group had no significant change(P>0.05); It had statistical significance between the two groups(P<0.05). Lymphocytes subsets comparison:there was no significant difference between the two groups of CD3, CD4, CD8, CD4/CD8 baseline(P>0.05). CD3 and CD4 were significantly higher and CD8 was lower and CD4/CD8 ratio was increased in the treatment group after treatment(P<0.05), the control group had no significant change(P>0.05). The difference was statistically significant compared between the two groups(P<0.05).Security: In clinical trials, there were no adverse reactions related with observation drug.It had not found abnormal changes related to the drugs and the observation before and after treatment in routine tests such as the blood,urine, stool and kidney function, electrocardiogram.Conclusion: The treatment group could obviously improve the TCM clinical syndrome, reduce serum HBs Ag markers titers, improve the proportion of lymphocyte subsets.Combined treatment were in favor of e antigen seroconversion promotion and achieving the immune control. The Study revealed the pathology of the disease of TCM Qi Du Yun,and indicated the intervention of Yiqi Jiedu Decoction could improve the antiviral efficacy. |
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