| Objective:Basing on summarizing up the experience of the instructors,on the rule of dispersing the depressed liver-energy and benefiting the spleen to eliminate dampness and detoxify,1st Gan bing decoction was formed.Under the guidance of norms for the treatment of chronic hepatitis B of the syndrome of liver depression and deficiency of the spleen Qi accompanied with damp-heat,an Clinical randomized controlled trial of efficiency and safety on the treatment of the method of dispersing the depressed liver-energy and benefiting the spleen to eliminate dampness and detoxify,objective to evaluate the efficiency and mechanism of action of this method on treating chronic hepatitis B of the syndrome of liver depression and deficiency of the spleen Qi accompanied with damp-heat,providing a shortcut for clinical treatment.Methods:In accordance with the principles of randomized,patients which have been diagnosed with chronic hepatitis B were randomly divided into treatment group and control group.The treatment group was given 1 st Gan bing decoction which is formed on the rule of dispersing the depressed liver-energy and benefiting the spleen to eliminate dampness and detoxify.The control group was treated with a similar positive drug-Longshen yigan granula.The Treatment lasted for 3 months,the change of some conditions of patients were observed before and after treatment as follows:clinical efficacy,mainly to improve the situation of TCM Syndrome,liver function,color Doppler ultrasound examination of the liver and the spleen,hepatitis B virus markers and observation of safety (including renal function,hematuria will be conventional and ECG,etc.), and in the light of " the guiding principles of clinical research for traditional Chinese medicine on the treatment of viral hepatitis of new drugs " criteria for efficiency of treating chronic hepatitis B,treatment of the two drug was compared.Results:1,the overall clinical effects of two groups:treatment group, the total effective rate was 88.37%,control group,the total effective rate was 81.39%,the overall clinical efficacy of the two groups showed no significant difference(P＞0.05).2,two groups of Chinese medicine after treatment than before the syndrome had improved(P＜0.01),the treatment group in improving the stool of patients with thin soft,poor apetite.weak such as burnout syndrome is better than the control group,there was statistically significance of the two groups(P＜0.05).3,comparing the two groups on improving liver function:the decreased numbers of ALT,AST in the two group after treatment were statistically significant(P＜0.05), decrease in comparison between the two groups was statistically significant (P＞0.05).ALB,GLO,TBIL,DBIL changes:After treatment,the values of apparent change happened in the treating group(P＜0.05),there was no significant change of the control group(P＞0.05).4,Comparison of changes of indicators of hepatitis B markers of the two groups in detection:HBsAg negative rate was 2.44%,HBeAg negative conversion rate was 9.30%, HBV-DNA negative conversion rate was 16.28%in the treatment group; control group,HBsAg negative rate was 0,HBeAg negative rate was 4.65%, HBV-DNA negative conversion rate was 11.63%,the comparison of the treatment group with the control group had no significant difference(P＞0.05).5,comparison of side effects:There were no adverse reactions and side effects.Conclusion:The method of dispersing the depressed liver-energy and benefiting the spleen to eliminate dampness and detoxify achieved good results on treating chronic hepatitis B with the syndrome of Liver Depression and Spleen Deficiency Syndromes relying on hot and humid, the compound etablished on it has the function of improving syndrome in Chinese medicine,and restoring liver function,played a role of protecting the liver,decreasing transamine and antiviraI effect.and is worthy of further promotion and mining clinically.
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