| [Objective] To evaluate the clinical efficiency and safety of the prescription of harmonizing and tonifying liver and spleen for the treatment of chronic hepatitis type B belonging to the type of Liver-qi stagnation and spleen deficiency objectively by clinical observation of the prescription of harmonizing and tonifying liver and spleen for the treatment of chronic hepatitis type B. The pills of harmonizing and tonifying liver and spleen are made up of DangShen, FaXia, YuJin, BaiShao, BaiZhu, FuLin and so on, with a function of smoothing Liver-qi and invigorating spleen and tonifying kinder.[Method] Use the method of contrasting randomly and Yiganning positive control to make a clinical research on 50 patients who get chronic hepatitis type B and belong to the type of Liver-qi stagnation and spleen deficiency, among them 37 patients belong to treatment group and 13 patients belong to control group. Treatment group take pills of harmonizing and tonifying liver and spleen and control group take Yiganning powder. The period of treatment is 3 months, then following-up visit for 6 months, all together 9 months. The observe content mainly contains the symptom of Traditional Chinese Medicine, liver function, virus of hepatitis B index and security index.[Result]①Analysis result of the improvement of the symptom of Traditional Chinese Medicine:Treatment group and control group can both improve the symptom of patients who get hepatitis B obviously, there is no significant difference(P>0.05)②Detection result of liver function:The two groups both have the effect to reduce ALT,AST and TBIL, there is no significant difference (P>0.05)③Detection result of etiology index:Before the treatment, HBeAg negative rates of treatment group and control group are both 50%, the negative rates of HBV-DNA are 43.75% and 61.11% separately. After 9 months upon the following-up visit, HBeAg negative rates are 65.62% and 55.55% separately, the negative rates of HBV-DNA are 65.62% and 61.11%, there is no significant difference (P>0.05). Before the treatment the negative rates of resist-HBc-IgM are 81.35% and 83.33% separately, After 9 months upon the following-up visit, they are 100% and 83.33%,treatment group shows better effect than control group, there is significant difference (P<0.05)④Criteria of synthesize curative effect:the total effective rates of treatment group and control group are 96.9% and 88.9% separately, treatment group shows a little better effect than control group, but there is no significant difference (P>0.05)⑤security index:the two groups have no adverse reaction, all cases are safe.[Conclusion] pills of harmonizing and tonifying liver and spleen has the effect of improving patients'symptoms, reducing ALT,AST and TBIL obviously and advancing HBV-DNA become negative,the synthesize curative effect is the same as the control group and it has high security. |