| Objectives To observe the clinical efficacy and safety of Qutan Huoxue Yunpi Decoction combined with metformin hydrochloride tablets in the treatment on obese Type 2 Diabetes Mellitus(T2DM)patients with phlegm-dampness and blood stasis syndrome,and to explore its partial mechanism by the level of adiponectin(APN)and leptin(LP).Methods 70 cases of obese T2 DM syndrome with phlegm-dampness stasis syndrome were randomly divided into control group(n = 35)and experimental group(n = 35).The control group was treated with metformin hydrochloride tablets,and the experimental group was treated with Qutan Huoxue Yunpi Decoction combined with metformin hydrochloride tablets.The observation period was 12 weeks in both groups.TCM syndrome scores and curative effect,blood glucose and blood lipid related indexes,Body Mass Index(BMI)、Waist circumference(WC)、Fasting insulin(FINS)、Homeostasis model assessmentinsulin resistance index(HOMA-IR)、APN、LP and liver and kidney function of the two groups were observed before and after treatment,and analyzed by Statistical software SPSS23.0.Among TCM syndrome score,blood glucose and blood lipid related indexes,BMI,WC,FINS,HOMA-IR,APN,LP,Aspartate aminotransferase(AST),Alanine aminotransfease(ALT),Blood urea nitrogen(BUN)and Serum creatinine(Cr)in liver and kidney function were all measured data and accord with normal distribution,so t test was used.The curative effect of TCM belongs to grade data,rank sum test was used.Results In the course of this trial,one patient fell off in each of two groups,and 68 cases were actually completed.There was no significant difference in age,sex,course of disease and observation indexes before treatment between the two groups(P > 0.05).1 TCM syndrome score and curative effect: after treatment,the TCM syndrome score of the experimental group was significantly lower than that of the control group(P < 0.05).The total effective rate of the experimental group and the control group was 94.12% and 61.76%.And the total effective rate of traditional Chinese medicine was significantly higher than that of the control group(P < 0.05).2 Indexes of glucose and lipid metabolism: after treatment,Fasting plasma glucose(FPG),Postprandial 2h blood glucose(P2HBG),Glycated hemoglobin(HBAlc),Low density lipoprotein cholesterol(LDL-C),Total cholesterol(TC)were significantly decreased and High-density lipoprotein cholesterol(HDL-C)was significantly increased in the experimental group,the difference was statistically significant(P < 0.05).The experimental group did not significantly reduce the level of Triglyceride TG(P > 0.05)3 Indexes related to obesity: WC and BMI decreased in both groups after treatment(P < 0.05),and the experimental group was superior to the control group(P <0.05).4 Comparison of FINS and HOMA-IR: After treatment,FINS and HOMA-IR decreased in both groups,and the experimental group was superior to the control group in comparison between the two groups,and the difference was statistically significant(P <0.05).5 Comparison of APN and LP: after treatment,the rise of APN in the experimental group was higher than that in the control group,and the decrease value of LP in the test group was higher than that in the control group,and the difference was statistically significant(P < 0.05).6 Safety index: in the course of treatment,there was no obvious abnormality in vital signs,blood,urine and stool routine and ECG between the two groups,and there was no significant difference in liver and kidney function(AST,ALT,BUN,Cr)before treatment,after treatment,4 weeks and 8 weeks(P > 0.05).Conclusions Qutan Huoxue Yunpi Decoction combined with metformin hydrochloride tablets can significantly improve the TCM clinical symptoms of obese T2 DM patients with phlegm-dampness and blood stasis syndrome,and effectively improve glucose and lipid metabolism,obesity related indexes,reduce IR,by increasing the level of APN and reducing the level of LP,improve the level of adipokines.There was no obvious adverse reaction in the course of taking medicine,and the safety was good.Figure 0;Table16;Reference 146... |
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