Objectives To explore the mechanism of Shi Jinmo medicine formula in treating type 2diabetes mellitus,T2 DM patients with IR,discriminated as syndromes of stagnation of lung and stomach and deficiency of spleen and kidney,were involved in this study and the clinical efficacy and safety of Shi Jinmo medicine formula were evaluated.Methods From March 2018 to December 2018,a total of 80 patients who met the experimental admission criteria were collected in the endocrinology outpatient of Cangzhou Hospital of Integrated Traditional Chinese.Patients were randomly divided into two groups by using a random number table,40 patients in each group.Patients in the experimental group took the granules of Shi Jinmo medicine formula before meals,which were dissolved in warm water,one dose a day and took it three times.Patients in the control group only took metformin(500 mg/pill)before meals and three times a day.The changes in patients’ condition,physical examination,symptom score,FBG and P2 HBG were recorded at weeks of 4 and 8.FBG,P2 HBG,HbA1c,FINS,TC,TG,LDL-C,HDL-C,hs-CRP,LP,APN,BMI,HOMA-IR and microRNA-29 were examined before and after the trail.Adverse events were recorded during the trail.The data were analyzed by SPSS19.0 statistical software and P < 0.05 was considered statistically significant.Results A total of 80 patients were enrolled in this trial.During the treatment,one case fell off in the experimental group and the control group respectively,thus the actual number of patients was 78.There are 39 patients in experimental group and control group respectively.1 General information: There was no significant difference in gender,age,weight and height between the two groups before treatment(P>0.05).2 Comparison of the average scores of TCM syndromes: Before treatment,there was no significant difference in the average score of TCM syndromes between the two groups(P > 0.05).After treatment,the data mentioned above of the two groups decreased and the average score in experimental group decreased obviously than that in control group(P<0.05).3 Indicators of glycolipid metabolism: There were no significant differences in FBG,P2 HBG,HbA1c,HOMA-IR,TC,TG,LDL-C and HDL-C between the two groups before treatment(P>0.05).After treatment,the indicators mentioned above of the two groups decreased,except that HDL-C increased(P<0.05).Compared with control group,indicators in experimental group decreased and HDL-C increased obviously(P<0.05).4 There was no significant difference in BMI and hs-CRP between the two groups before treatment(P>0.05).After treatment,BMI and hs-CRP decreased in both groups and hs-CRP decreased remarkably in experimental group than in control group(P<0.05).There was no significant difference in BMI between the two groups(P>0.05).5 There was no significant difference in LP and APN between the two groups before treatment(P>0.05).After treatment,the APN levels in the two groups increased,the LP levels in experimental group decreased(P<0.05),while the LP levels in control group did not change significantly(P>0.05).Compared with control group,the reduction of LP and the elevation of APN were more obvious in experimental group(P<0.05).6 The levels of microRNA-29 in all cases before and after treatment were set to 1 Compared with before treatment,the levels of microRNA-29 of the two groups decreased after treatment(P<0.05),but there was no significant difference between the two groups(P>0.05).7 Safety evaluation: During the treatment,there were no significant abnormalities in liver and kidney function,blood andurine routine of the two groups.One case of diarrhea occurred in the treatment group,which was relieved in one day.In the control group,there were 2 cases of abdominal distension and 1 case of appetite loss.Conclusions 1 Shi Jinmo medicine formula has the effect of reducing FPG,P2 HBG and HbA1 c,and its efficacy is superior to control group,which suggesting that Shi Jinmo medicine formula has the effect of lowering blood glucose.2 To a certain extent,Shi Jinmo medicine formula could reduce TC,TG and LDL-C,increase HDL-C and improve blood hypercoagulability.Meanwhile,this prescription could reduce hs-CRP,HOMA-IR,increase insulin sensitivity and improve micro-inflammation in patients of T2 DM with IR and has a certain effect on weight-loss.3 In obese patients with T2 DM,serum LP level was negatively correlated with IR index and APN level was positively correlated with IR index,which was consistent with relevant literature reports.Shi Jinmo medicine formula could significantly reduce LP level,increase APN level and inhibit the expression of microRNA-29.These demonstrates that Shi Jinmo medicine formula improves IR by promoting peripheral tissue glucose utilization and stabilizing blood glucose.Compared with control group,the adverse reactions were fewer and the safety was higher in the treatment of Shi Jinmo medicine formula.Figure 0;Table16;Reference 179. |