| ObjectiveTo evaluate the immune functions of Heheshuyangfang to chronic hepatitis B by clinical research and to probe into the immunologic mechanism of its action to the liver injury induced by CC14in animal experiment, which provides new reference and basis for Heheshuyangfang is further applied to clinical treatment and new therapy plan of CHB combined traditional Chinese and western medicine is found out.MethodsClinical study adopts the randomized controlled Parallel design, included the number of cases35cases, collected21cases for the treatment group and control group14cases. In the basis of:entecavir, oral, treatment group takes Heheshuyangfang everyday, concentrated to200ml;control group takes placebo once a day. before and after12weeks,24weeks treated, observed indicators include results of Clinical symptoms, signs, biochemical examination, immune function examination. According to the curative standard, Both groups makes a comparison for Further deepening clinical research of Heheshuyangfang.In animal experiment,60SD rats were randomly divided into six groups, control group, model group, biphenyl double ester treatment group (50mg/kg), Heheshuyangfang in the high, middle, low dose groups (83. Og/kgã€41.5g/kgã€16.6g/kg). The rat model of hepatic stagnation and spleen deficiency were established by chronic astrictingã€excess fatigue and out of constant diet on rats for constant four weeks, at the same time, in accordance with0.2ml/kg weight, intraperitoneal injection of normal saline in control group, other groups in the same way0.2ml/kg intraperitoneal injection of30%CC14peanut oil solution,2times per week, continuous injection for4weeks to get liver injury.Building4weeks later, the treatment group were given Heheshuyangfang in the high, middle, low dose and biphenyl double ester by gavage, lml/100g;while control group and model group were given a gavage of distilled water of the same volume with the drug, once a day for constant four weeks. After8weeks, All animals fasting12h and collecting Abdominal aortic blood4ml at eight o’clock, to detect indicators including ALTã€ASTã€GGT〠IL-10ã€IL-12and Check the pathology of organization.ResultsThe clinical studies showed that the total effective rate of treatment group and control group were90.48%,57.14%, the difference was statistically (P<0.05). In comparing the symptom score, The results showed that both groups of each group had different degree of improvement in symptoms, compared with those before treatment,the difference was statistically (P<0.01), and after treatment,the effect of treatment group was more advanced than of the control group (p<0.01). ALTã€ASTã€GGTã€CD4+ã€CD8+〠CD4+/CD8+of both groups after treatment, the difference was statistically (p<0.05or p<0.01). Treatment group was even more pronounced improved in liver function and immunity(p<0.05). observation of two groups HBeAg and HBV-DNA negative conversion overcast found that treatment group compared with control group, the difference was statistically (p<0.05) in HBV-DNA negative conversion overcast, but no difference in HBeAg negative conversion overcast.The experimental results showed that compared with model group, Heheshuyangfang in the high, middle, low dose groups were even more pronounced increased in the weight(p<0.05).ALTã€ASTã€GGTã€IL-12of serum and MDAã€HyP of hepatic homogenate in Heheshuyangfang in the high group and biphenyl double ester treatment group were more lower than model group(P<0.05or P<0.01), while the level of IL-10more higher than model group. ALTã€ASTã€GGT of serum and MDAã€HyP of hepatic homogenate in Heheshuyangfang in the high, middle, low dose groups compared with biphenyl double ester treatment group, the difference was not statistically(p>0.05). while IL-12in Heheshuyangfang in the high group was more lower than biphenyl double ester treatment group. Pathological changes of organization was pronounced relieved in Heheshuyangfang in the high, middle, low dose groups.ConclusionHeheshuyangfang can improve the symptoms, signs, liver function, immune index and has no obvious adverse reaction in CHB patients with hepatic stagnation and spleen deficiency. it is a kind of safe and effective compound Chinese medicine. Animal studies have shown that Heheshuyangfang can effectively prevent and reverse the occurrence or development of liver injury induced by CC14, and has good immunomodulatory effects in liver injury rats. The immune regulation mechanism of Heheshuyangfang May involve in the participationin of flammatory factors that cells immune-mediated, and be closely related to the release of proinflammatory factor such as IL-12and the secretion of suppression inflammatory factors such as IL-10. |