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Objective To investigate the clinical effects of Compound Biejia Ruangan Tablet (CBRT) combined with entecavir in patients with chronic hepatitis B with hepatic fibrosis.Methods Totally 92 cases of patients with hepatic fibrosis of chronic hepatitis B in Ankang people's hospital from January 2013 to May 2016 were divided into observation group (n =45) and control group (n =47),patients in observation group were treated with CBRT combined with entecavir,and patients in the control group were treated with entecavir.Treatment was for 48 weeks.The liver function,liver fibrosis,serum inflammatory factors,and adverse reactions were compared between two groups.Results After treatment,the ALT,AST,TBIL,and ALB/GLB levels of two group were significantly lower than those before treatment (P ＜ 0.05),but there was no significant difference between two groups after treatment.After treatment,the PCⅢ,IV-C,HA,LN,IL-6,IL-4,IL-10,and TNF-α levels of two group were significantly lower than those before treatment (P ＜ 0.05),and the PCⅢ,IV-C,HA,LN,IL-6,IL-4,IL-10,and TNF-α levels of observation group were significantly lower than those of control group (P ＜ 0.05);there was no statistically significant difference in the incidence of adverse reactions between two groups (P ＜ 0.05).Conclusion CBRT combined with entecavir is safe and effective to treat liver fibrosis of chronic hepatitis b,and it could significantly improve liver function,improve the degree of liver fibrosis,and reduce the level of serum inflammatory factors.
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OBJECTIVE:To analyze the cost-effectiveness of two regimens in the treatment of chronic hepatitis B fibrosis. METHODS:112 cases of chronic hepatitis B fibrosis were divided into Compound biejia ruangan tablet group (group A,n=56) and Anluo huaxian pill group(group B,n=56). Both groups received Entecavir dispersible tablets combined with relevant Chinese patent medicine. The liver fibrosis index and transient elastography of 2 group were detected before and after treatment,TCM symp-tom score and effective rate calculation were conducted to compare the cost-effectiveness of 2 groups. RESULTS:The cost,effec-tive rate and cost-effectiveness ratio of group A were 9 227.10 yuan,74.11% and 12 451;those of group B were 8 202.90 yuan, 69.28%and 11 840;incremental cost-effectiveness ratio was 21 205. Group B showed a better cost-effectiveness. Result of sensitiv-ity test was same to that of cost-effectiveness analysis. CONCLUSIONS:The cost-effectiveness of Anluo huaxian pill combined with Entecavir dispersible tables is better than Compound biejia ruangan tablet combined with Entecavir dispersible tables in the treatment of chronic hepatitis B fibrosis.
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Objective: To investigate the integral dissolution model based on biological potency in order to evaluate the dissolution of Compound Chinese materia medica (CCMM) in vitro. Methods: The contents of paeoniflorin, phillyrin, ginsenoside Rg1, and adenosine of ten batches of Compound Biejia Ruangan Tablet (CBRT) were determined at different times. The self-defined weighting coefficient based on the contents has been created to establish the integral dissolution model. In addition, the biological potency of CBRT was measured by MTT assay. Then, the f2 similar factor was used to evaluate the similarity of the batches. Results: Compared with batch a, some batches' f2 values of paeoniflorin and adenosine were less than 50, while f2 values of ginsenoside Rg1, phillyrin, and integral component were more than 50. Likewise, ginsenoside Rg1, phillyrin, and integral component were all in good correlation with biological dissolution. Conclusion: The results of the integral dissolution based on biological test of CBRT demonstrate that the bioassay method may be a promising supplement for its quality evaluation.
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Objective: To explore the effects of different pulverization fineness of solid preparations of Chinese materia medica on their in vitro dissolution, using MTT method combined with HPLC. Methods: Compound Biejia Ruangan Tablet (CBRT) was used as model drug, and MTT method was used to obtain the characteristic cell inhibitory rate by different pulverization fineness of dissolving solutions in the dissolution medium (phosphate buffer, pH value 7.4) at different time points. From these results, the cumulative dissolution of CBRT based on cell inhibitory rate was obtained. The dissolution rates of paeoniflorin was determined by HPLC method. Using f2 similar factor, the relevance of these two methods was evaluated. Results: Dissolution of paeoniflorin is changed with the change of pulverization fineness, the accumulative dissolutions of 200 and 300 meshes in vitro were higher than those of other meshes. The results showed that f2 values of 200 and 300 meshes were more than 50, indicating that there was a good correlation between the two methods of measuring the dissolution rate. Conclusion: The results show that the biological potency detection could be used to screen the particle size of CBRT. Considering the production cost of CBRT, 200 mesh is the best particle size.
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Objective: To explore the chemical-biological assay pattern for quanlity control and evaluation of Chinese materia medica solid preparations (CMMSP). Methods: MTT assay was used to obtain the characteristic cell inhibitory rate on LX-2 hepatic stellate cells by Compound Biejia Ruangan Tablet (CBRT) dissolving solutions in PBS dissolution medium with pH 7.4 for different time periods. From these results, the cumulative dissolution of CBRT was obtained based on the cell inhibitory rate. The dissolution rates of paeoniflorin, phillyrin, and ginsenosides Rg1 were determined by HPLC method. A novel approach of self-defined weighting coefficient based on the quality had been created to establish the integrated dissolution rate model. Then f2 similar factor method was used to evaluate the relevance of these two methods. Results: The f2 values for paeoniflorin, phillyrin, ginsenosides, and the integration dissolution were 43, 58, 61, and 59, respectively. It was indicated that the dissolution of multicomponent integration could fully reflect the biological potency of all parties. Conclusion: The biological activity-multicomponents integrated evaluation method of dissolution is expected to be one of the effective means for in vitro dissolution test of CMMSP.