Pharmacological Study And Clinical Observation On The Treatment Of Nonalcoholic Fatty Liver Diseases With Danqing Tablets

Objective:By animal experiment and clinical observation, evaluate the efficacy and safety of the treatment of nonalcoholic fatty liver diseases with Danqing Tablets.Methods:1. Animal Experiment:By ig Danqing Tablets0.64g/kg,1.28g/kg,2.56g/kg to SD rat models induced by high-fat-feed, compared with Fenofibrate, Xuezhikang Capsule, Dongbao Gantai Tablet, successive administration for21days, to study the blood biochemical parameters change and histopathological change.2. Clinical Observation:Using randomized double-blind placebo control experimental design, choosed60patients according to inclusion criteria. They were randomly divided to treatment group30patients (off1) and placebo group30patients (off1).The treatment group received Danqing Tablets,5pills each time,3times a day orally for8weeks; control group was given simulations,5pills each time,3times a day orally for8weeks. All patients were assessed before and after treatment for clinical symptoms, indexes for therapeutic effects (serum lipid, liver function, the ratio of CT of liver:spleen), safe indexes (kidney function, blood and urine routine, electrocardiogram).Results:1. Animal Experiment:By ig. Danqing Tablets1.28g/kg,2.56g/kg to SD rat models induced by high-fat-feed for21days, can significantly decrease the serum TC, TG and LDL-C(P<0.05); can significantly decreased the liver TG(P<0.05); can significantly decrease the liver MDA and the serum AST(P<0.05); can significantly increase the liver SOD and GSH (P<.0.05); can reduce the incidence of hepatocellular fatty degeneration.2. Clinical Observation:(1) Total effect of laboratory indexes:the total effective rate of the treatment group is96.55%, while the placebo group is65.51%, there is no statistical significance between two groups (P<0.01)(2) Total effect of tcm symptom:the total effective rate of the treatment group is93.10%, while the placebo group is37.93%, there is no statistical significance between two groups (P<0.001)(3) Total score of tcm symptom:①within the group:before and after treatment, the treatment group (P<0.001) shows significant improvement; the placebo group (P>0.05), shows no significant improvement.②between two groups:after treatment, there is statistical significance between two groups(P<0.001), indicate that the treatment group is significantly better than the placebo group.(4) Effect of every tcm symptom:①within the group:within the treatment group, liver discomfort, bitter taste and dry in mouth, abdominal distension, poor appetite, hypodynamia, nausea and vomiting, constipation show significant improvement (P<0.01); while scanty dark urine tongue picture, pulse condition show no significant improvement(P>0.05). Within the placebo group, constipation shows significant improvement (P<0.01); while liver discomfort, bitter taste and dry in mouth, abdominal distension, poor appetite, hypodynamia, nausea and vomiting, scanty dark urine tongue picture, pulse condition show no significant improvement (P>0.05).②between two groups:before treatment, all symptoms (P>0.05) are comparable; after treatment, at four symptoms, which are liver discomfort (P<0.05), abdominal distension, hypodynamia, constipation (P<0.01), the treatment group shows significantly better than the placebo group; while at six symptoms, which are bitter taste and dry in mouth, poor appetite, nausea and vomiting, scanty dark urine, tongue picture, pulse condition, the treatment group shows same efficacy with the placebo group.(5) Laboratory indexes for efficacy:①within the group: within the treatment group, TC, ALT, AST show improvement (P<0.05) TG, the CT ratio of liver and spleen (P>0.05) are no significant improvement. within the placebo group, before and after treatment, all the indexes(P>0.05)are no significant improvement.②between two groups: before treatment, all indexes (P>0.05) are comparable; after treatment, at ALT (P<0.05)、AST (P<0.01), the treatment group shows significantly better than the placebo group; while at TC, TG, the CT ratio of liver and spleen, the treatment group shows same efficacy with the placebo group.(6) Laboratory indexes for safety:Within the treatment group, before and after treatment, blood routine (RB、HGB、WBC、PTC、 LYM、LNEUT), kidney function (BUN, Cr), urine routine, electrocardiogram show no statistical significance (P>0.05). We also detecte no obvious adverse reactions. Above indicates that the drug is safty.Conclusion:1. Animal Experiment:Danqing Tablets can decrease serum lipid and liver lipid in rat, incease the abilitiy of antioxidation in liver, decrease the level of lipid peroxidation, potect liver cells, improve liver function, decrease the incidence of fatty degeneration in liver cells, so it can treat NAFLD.2. Clinical Observation:during the treatment of NAFLD (damp-heat syndrome of hepatobiliary) with Danqing Tablets, at total effect of laboratory indexes and total effect of tcm symptom, the treatment group are significantly better than the placebo group; at liver discomfort, abdominal distension, hypodynamia, constipation, the treatment group are significantly better than the placebo group; at ALT and AST, the treatment group are significantly better than the placebo group; detecte no obvious adverse reactions, indicates that the drug is safty.Above all can provide experimental evidences for the treatment of Nonalcoholic Fatty Liver Diseases with Danqing Tablets.