| ObjectiveTo observe the improvement of curative effect and related safety indexes of Shugan Huatan Xiaoturbidity prescription in patients with liver depression and spleen deficiency containing phlegm type T2 DM complicated with NAFLD,so as to provide certain clinical trial basis for TCM prevention and treatment of chronic diseases.MethodsAccording to the diagnostic criteria in the latest clinical guidelines for type 2 diabetes and nonalcoholic fatty liver disease in China,the inclusion criteria and exclusion criteria of this study were formulated.60 patients with T2 DM and NAFLD with liver depression and spleen deficiency and phlegm were randomly divided into treatment group and control group,30 cases in each group.The control group was treated with lifestyle intervention and basic treatment of Western medicine,and the treatment group was treated with Shugan Huatan Xiaozhuo Decoction on the basis of the control group.The improvement of clinical efficacy and TCM syndrome score before and after treatment between the two groups was compared.Blood glucose(FPG,2HPG,Hb A1C),fasting insulin(FINS),insulin resistance index(HOMA-IR),body mass index(BMI),waist to hip ratio(WHR),blood lipid(TC,TG,LDL-C,HDL-C),liver function(ALT,AST,GGT),liver B-ultrasound score and T were recorded The values of NF-α and IL-6indexes were unified after 3 months of treatment and analyzed with statistical software.Results(1)Comparison of clinical efficacy : After treatment,the total effective rates of the treatment group and the control group were 93.3 % and 66.6 %,respectively.The treatment group was more significant in improving clinical efficacy(P < 0.05).(2)Comparison of TCM syndrome scores : After treatment,the TCM syndrome scores of the two groups were lower than before;after treatment,the scores of TCM syndromes in the treatment group decreased more significantly(P< 0.01).(3)Comparison of blood glucose and insulin resistance : After treatment,FPG,2HPG,Hb A1 C,FINS and HOMA-IR in the two groups were lower than before(P< 0.01,P< 0.05);after treatment,the blood glucose and fasting insulin in the treatment group decreased more significantly(P < 0.01).(4)Comparison of BMI and WHR : There was no significant difference in BMI and WHR between the two groups before and after treatment(P>0.05).(5)Comparison of blood lipid levels : After treatment,the levels of TC,TG and LDL-C in the two groups were lower than before,and the level of HDL-C was increased(P< 0.01).After treatment,the improvement of blood lipid level in the treatment group was more significant(P< 0.01).(6)Comparison of liver function : After treatment,the levels of ALT,AST and GGT in the two groups were lower than before(P< 0.01,P< 0.05);after treatment,the liver function level of the treatment group decreased more significantly(P< 0.01).(7)Comparison of liver color Doppler ultrasound : After treatment,there was no difference in liver B-ultrasound in the control group(P>0.05),and the improvement of liver B-ultrasound in the treatment group was different from that before(P<0.01).Compared between the two groups after treatment,the improvement of liver B-ultrasound indexing in the treatment group was more significant(P < 0.05).(8)Comparison of TNF-α and IL-6 : After treatment,the levels of TNF-α and IL-6 in the two groups were lower than before(P< 0.01).After treatment,the levels of TNF-α and IL-6 in the treatment group decreased more significantly(P < 0.01).(9)Safety analysis : During the treatment of the two groups,there was no abnormality in the monitoring of the three routine,renal function and electrocardiogram,and no allergic reaction and other discomfort.ConclusionShugan Huatan Xiaozhuo Decoction can improve the clinical symptoms of traditional Chinese medicine in patients with T2 DM and NAFLD of liver depression and spleen deficiency with phlegm,reduce the score of traditional Chinese medicine syndrome,control the level of blood glucose and blood lipid,and improve the liver function,liver color ultrasound and inflammatory index of patients.No adverse reactions occurred during the treatment,and the safety was high.It is recommended for clinical application. |