| Objective:Based on Acrid-release and Bitter-downbearing Therapy,to observe the effectiveness and safety of Qingre Qutan formula in the treatment of overweight/obese type2 diabetes(phlegm heat syndrome).Methods:This research,72 patients with overweight/obese type 2 diabetes(phlegm heat syndrome)were randomly divided into 2 groups,36 cases in the control group and 36 cases in the treatment group.The control group was treated with basic treatment combined with metformin hydrochloride tablets,treatment group combined with Qingre Qutan formula prescription on the basis of control group for 12 weeks.Observed the both groups before and after treatment of FPG,2h PG,Hb A1 C,FINS,HOMA-IR,weight,BMI,waist circumference,hip circumference,waist-to-hip ratio,and TCM evidence score.To evaluate the objective efficacy and safety of the Qingre Qutan formula.Results:1.Comparison of the efficacy of TCM evidence:The effective rate of the treatment group was 87.88% and the effective rate of the control group was 62.5%,and the overall effective rate of the treatment group was better than that of the control group(P<0.05).Comparison of individual symptoms,all the clinical symptoms of TCM in the treatment group were significantly improved,there was a statistically significant difference before and after treatment(P<0.05).In the control group,"Obesity,bloated abdomen,dry mouth and thirst,excessive water intake,dry stools",statistically significant(p<0.05),There were no significant differences in chest tightness epigastric fullness,cold drink preference,upset and yellow urine before and after treatment(P>0.05).In comparison between the groups,except bloated abdomen,the improvement of other TCM clinical symptoms in the treatment group was better than that in the control group,and there was statistical difference(P<0.05).2.Glucose index:FPG,2h PG and Hb A1 c decreased significantly after treatment in both groups(P<0.01);the treatment group was superior to the control group(P<0.05).3.Insulin-related indicators:FINS and HOMA-IR improved in both groups after treatment(P<0.01),with the treatment group outperforming the control group(P<0.05).4.Obesity-related indicators:Patients in both groups showed significant improvements in weight,BMI,body weight,waist circumference,hip circumference and waist-to-hip ratio after treatment(P<0.05).Based on the results of the comparison between groups it is clear that the treatment group was better than the control group in improving BMI,waist circumference and waist-hip ratio,with statistical differences in comparison(P<0.05),and was comparable to the control group in improving weight and hip circumference,with no statistical significance in comparison(P>0.05).5.Safety indicators:the blood and urine routine and liver and kidney function indicators were within the normal range in both groups before and after treatment.Conclusion:Based on the Acrid-release and Bitter-downbearing Therapy,the treatment of overweight/obese patients with type 2 diabetes mellitus(phlegm heat syndrome)by Qingre Qutan formula can effectively improve clinical symptoms,reduce blood glucose and insulin-related indexes,,and have definite efficacy in reducing body mass index,waist circumference and waist-hip ratio. |