| Objective:By double-blind method to study the traditional Chinese medicine "Shugan Jianpi San" clinical curative effect on patients with nonalcoholic fatty liver.Method:From May 2014 to January 2016, 80 patients with non alcoholic fatty liver were randomly divided into the experimental group and the control group in 40 cases of non alcoholic fatty liver patients in the 251 Hospital of PLA. The experimental group was given Shugan Jianpi San received oral placebo, flour based, for 10 weeks. Record two groups of patients for sex, age, course of disease, and in accordance with the related criteria for evaluating the efficacy of before and after the intervention of two groups of patients mainly TCM symptoms score, symptom total score, abdominal CT of liver / spleen C indeed T ratio, the basis of disease distribution(diabetes, hyperlipidemia hyperlipidemia, cholecystitis, liver cyst), body mass index(BMI). Liver function: alanine amino shift enzyme(ALT), aspartate amino shift enzyme(AST), glutamic acid acyltransferase(γ-GT); a series of blood lipid: total cholesterol(TC), triglyceride(TG), high density lipoprotein cholesterol(HDL-C), low density lipoprotein cholesterol(LDL-C); quality of life(QOL) table. And before treatment, treatment for fifth weeks, after treatment to monitor the urine routine, liver and kidney function tests and electrocardiogram examination and other drug side effects.Result:1 Comparison of curative effect of Chinese MedicineAfter drugs and life intervention, the results showed that the experimental group on the main clinical symptoms(hypochondrium distending pain, abdominal distension full, dry mouth, mouth pain, limb trapped heavy, greasy yellow tongue coating) was better than the control group and symptoms of major improve the total efficiency is better than the control group, the difference is significant statistical significance(P < 0.01).2 TCM syndrome integral comparisonsAfter drugs and life intervention, the results showed that the experimental group of syndromes integral was better than the control group, the difference is significant statistical significance(P < 0.01).3 Changes of liver enzyme indexes before and after treatmentThe results showed that after drugs and life intervention. After the treatment in the experimental group, compared with before treatment, Shugan Jianpi scattered with life style intervention on body mass index(BMI) and liver enzymes(alt, AST and γ-GT) has better improving effect(P < 0.05 or 0.01).Treatment group and control group after compared, the experimental group of liver enzymes(alt, AST and γ-GT) has better improving effect(P < 0.05 or 0.01), although the test group on body mass index(BMI) improved significantly compared with the control group, but between the two groups no significant difference(P> 0.05).4 Changes of blood lipid indexes before and after treatmentThe results showed that after drugs and life intervention. After the treatment in the experimental group, compared with before treatment, Shugan Jianpi scattered with life style intervention on blood lipid(TC, TG) has a good effect, and the difference was statistically significant(P < 0.05 or 0.01). Although there was a certain improvement effect on the blood lipid index HDL-C and LDL-C, there was no significant difference(P> 0.05).Patients in experimental group and control group after compared, the experimental group on indexes of blood lipid(TC, TG) is better, and the difference was statistically significant(P < 0.05), blood lipids HDL-C, LDL-C in the test group and the control group treatment after no statistical difference(P> 0.05).5 Changes in the quality of life before and after treatment in SF-36The results showed that after drugs and life intervention. After the treatment in the experimental group, compared with before treatment, Shugan Jianpi scattered with life style intervention on the SF-36 quality of life has a good effect, the specific performance after the intervention of physiological function, physical function, bodily pain, general health, vitality, mental health, the total score of quality of life is better, and the difference is statistically significant(P< 0.05 or 0.01). While the control group was given a placebo plus life intervention, the program only on the physiological function, physiological function, mental health, and quality of life total score has improved(P< 0.05, or 0.01). Other indicators have improved, but did not reach statistical differences(P> 0.05).Patients in experimental group and control group after compared and experimental group of physiological function, physiological function, energy, mental health, the total score of quality of life improvement is superior to the control group, the difference has statistical significance(P<0.05).6 Compare the overall clinical efficacy of the treatment group and the controlAfter a drug and life intervention, results show that the overall affect of the test group(95%) than the control group(72.50%), with significant difference(P < 0.01).Conclusion:1 "Shugan Jianpi " Chinese medicine prescription of stagnation of liver Qi with deficiency of the spleen syndrome non clinical symptoms and signs of patients with alcoholic fatty liver has a good effect.2 Traditional Chinese medicine prescription of "Shugan Jianpi " safe and effectively improve liver stagnation and spleen deficiency syndrome of non alcohol fatty liver patients with hepatic enzyme and blood lipid indexes;3 "Shugan Jianpi" Chinese medicine prescription of stagnation of liver Qi with deficiency of the spleen syndrome non alcoholic fatty liver patients’ quality of life has a good effect. |