| Objective:To evaluate the clinical efficacy and saf ty with Huo Xue Hua Tan granules treating against NASH. NASH refers to the liver cell ballooning and lobular neutrophil-based mixed inflammatory cell infiltration on the basis of the fatty degeneration of liver cells, except the alcohol and other clear factors causing liver damage. The incidence of NASH is currently increasing year by year, which is becoming a serious threat to people's health of the whole world·The main method of the western treatment against NASH is taking the oral medicine, which are very expensive drugs and although some drugs have some degree of lipid-lowering effect, but can be more concentrated in the liver lipid metabolism, which increasing hepatic fatty degeneration and liver dysfunction. Therefore, seaking for a safe and effective comprehensive treatment from traditional Chinese medince, has an very important theoretical and clinical value. It is confirmed that the Huo Xue Hua Tan granules have a great clinical effect, according to the clinical observation on 50 patients.Method: 50 patients were selected from hepatopathy center in Hubei Chinese medicine hospital outpatient department, which are in line with western diagnostic criteria of NASH and the basic chinese syndrome type is phlegm and moisture stagnation. Selected cases were randomly divided into treatment group and control group. Both groups were treated under the health education, diet and exercise on the basis of drug therapy. There were 25 cases in the treatment group, given the Chinese self-square and Chinese plus or minus decoction (both are Chinese herbal medicine granules), one dose blunt twice per day; control group was given polyene phosphatidylcholine (Essentiale) capsules,456mg each time, three times a day, while taking simulation, plus or minus side granules, one dose blunt twice per day. The course of treatment group and control group were both three months, followed up for the next three months. The main observation is the changes of symptoms and signs on the patients, liver function (ALT), liver/spleen CT value,triglyceride before and after treatment and the safety evaluation.Results:1.Clinical effection comparison of two groups:The total effective rate was 88% in the control group, while the total effective rate was 84%, the two groups showed no significant clinical differences (P> 0.05).2. The TCM syndrome score comparison of two groups:the comparison of two groups before and after treatment, P <0.05, manifested significant difference; after the treatment, the treatment group of TCM symptom score compared with the control group, showed no significant difference (P<0.05). 3. The comparison of two groups with the primary efficacy index: ALT, liver/spleen CT value and value of serum TG of two groups compared before and after treatment, P<0.05, indicated significant difference; two groups compared after the treatment, P> 0.05, indicated no significant difference.4. The comparison of the clinical efficacy of ALT of two groups after the treatment:after treatment, the effective rate was 96% in the treatment group while the control group was 92%, compared with two groups there were no significant difference (P> 0.05).5. The comparison of the clinical efficacy of liver/spleen CT value of two groups after the treatment:after treatment, the effective rate was 80% in the treatment group while the control group was 60%, compared with two groups there were no significant difference (P> 0.05).6. The comparison of the clinical efficacy of triglyceride of two groups after the treatment:after treatment, the effective rate was 80% in the treatment group while the control group was 76%, compared with two groups there were no significant difference (P> 0.05).7. Safety detection:There were no findings and observation of drug-related adverse reactions after the treatment. And the results of blood, urine and stool routine test, ECG and renal function (BUN, Cr) compared with before, declared no significant anomalies.Conclusion:The results of this study menifested:The Huo Xue Hua Tan granules can play a good effect on non-alcoholic steatohepatitis. It can not only improve the clinical symptoms, release the liver function, lower the serum triglyceride levels,but also reduce the severity of fatty liver, improve the life quality of of patients. It is effective, reliable, safety, and has non-toxic side effects. |
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