Clinical Study On Xiaozhengsanji Ⅱ Prescription In The Treatment Of Non-alcoholic Fatty Liver Disease

The purpose of this study was to evaluate the clinical efficacy and safety of Xiaozheng Sanji Ⅱ Prescription in treating non-alcoholic fatty liver disease(NALFD)patients with phlegm-blood stasis syndrome by observing the changes of clinical symptoms,signs,abdominal B-mode ultrasonography,liver function(ALT),blood lipid(TG,TC).Methods 60 cases of NALFD were selected from the geriatrics department of Shijiazhuang Hospital of Traditional Chinese Medicine from December 2017 to October 2018.The patients were divided into two groups,the treatment group and the control group,with 30 cases in each group.The patients in the treatment group were given oral Decoction-free granules(Huangqi,Wangbuliuxing,Zhebeimu,Zaojiaoci,Shanzha,Heye,Lulutong,Banxia,Fuling,Haizao,Kunbu),while the patients in the control group were given oral polyene phosphatidylcholine capsules(Yishanfu)for12 weeks.Both the treatment group and the control group were given basic dietary guidance during the treatment period.The changes of body mass index(BMI),TCM symptoms,syndrome scores,laboratory biochemical indexes,liver function(ALT),blood lipids(TG,TC)and abdominal B-mode ultrasonography before and after treatment were observed and compared between the two groups.The results showed that there was no significant difference in the general data including age,sex,course of disease between the treatment group and the control group before treatment(P>0.05).There were no abnormalities in blood routine,urine routine,stool routine,renal function and electrocardiogram of 60 patients before treatment.After treatment,the body mass index(BMI),liver function(ALT),blood lipid(TG,TC)of the two groups decreased,and there were significant differences between the two groups(P<0.01),but there was no significant difference between the two groups after treatment(P>0.05).The improvement of B-mode ultrasonography of the two groups before and after treatment was compared,and one patient in the treatment group changed from moderate to mild.One patient in the control group changed from severe to moderate,and the other patients had no significant changes in light,medium and severe.There was no significant difference before and after treatment(P>0.05),and there was no significant difference between the two groups.The total effective rates of the treatment group and the control group were80.00%and 63.33%,respectively.There was no significant difference between the two groups by X~2 test(P>0.05).In the treatment group,6cases were clinically controlled,18 cases were markedly effective,2 cases were effective and 4 cases were ineffective.The total improvement rate was 93.33%.In the control group,3 cases were clinically controlled,11cases were markedly effective,5 cases were effective and 11 cases were ineffective.The total improvement rate was 63.33%.There was a significant difference between the two groups by rank sum test(P<0.01).It is concluded that Xiaozheng Sanji Formula Ⅱ can effectively treat the syndrome of phlegm and blood stasis in non-alcoholic fatty liver disease,and can effectively improve TCM syndromes;Xiaozheng Sanji Formula Ⅱ can also reduce the BMI of NALFD and improve the level of TC,TG and ALT;Xiaozheng Sanji Formula Ⅱ has good safety and ease of use;it is worth promoting research and application.