| Objective: To observe the clinical efficacy of compound Hezhong Jiangzhuo Tiaotang Decoction in the treatment of blood glucose and blood lipid in patients with obese type 2 diabetes mellitus（T2DM）with phlegm turbid obstruction.Meanwhile,Based on the second-generation sequencing technology of bacteria,the effects of Hezhong Jiangzhuo Tiaotang Decoction on intestinal flora of obese T2 DM patients with phlegm turbid obstruction were observed,and the possible mechanism of the treatment of obese T2 DM with Hezhong Jiangzhuo Tiaotang Decoction was discussed.Method: In this study,a randomized,controlled study was conducted to collect obese T2 DM patients who met the inclusion criteria in the outpatient department of endocrinology,Kaifeng Hospital of TCM.After 2 weeks screening period were included in the 66 cases,were randomly divided into treatment group（Hezhong Jiangzhuo Tiaotang Decoction,granules,one day one dose,taken in the morning and evening）and the control group（Metformin hydrochloride,0.5g/time,2 times a day,oral administration）,course of treatment for 12 weeks.General clinical data collection,blood sugar,blood fat clinical biochemical indicators and stool specimens,the total DNA extraction subjects stool specimens microbial group,bacterial community structure research using PCR amplification of 16 S r RNA,using lllumina PE250 sequencing,the original PE reads to stitching,quality control,and in addition to the noise filtering,OTU clustering analysis,species diversity,species composition and the variance analysis.Results:1 Clinical efficacy（1）Comparison of TCM syndrome efficacy and symptom scores: The total effective rates of TCM syndromes in the treatment group and the control group were 87.5% and 64.52%,respectively.The total efficacy of the TCM syndromes in the treatment group was better than that in the control group（P<0.05）.After treatment,the overall level of the total symptom score of the two groups was lower than that before,and the improvement of the total symptom score of the treatment group was better than that of the control group after treatment,with statistically significant difference（P<0.05）.Compared with before treatment,the scores of physical obesity,abdomen fullness,and thirst-free drinking were significantly reduced in both groups（P<0.01）,and the weight loss,drowsiness,and sticky mouth in the treatment group were observably lower than before treatment（P<0.01）;there was no marked difference in the remaining indicators between the two groups after treatment compared with that before treatment（P>0.05）.Comparing between the groups,the treatment group’s reduction of appetite and sticky mouth was dramatically better than the control group（P<0.01）,and the treatment group was better than the control group in reducing drowsiness and dizziness（P<0.05）.（2）Comparison of blood glucose related indicators: After treatment,fasting plasma glucose（FPG）,blood sugar 2 hours after meal（2h PG）,and glycosylated hemoglobin（Hb A1c）in the two groups were observably lower than before treatment,and the difference was statistically significant（P<0.01）;comparison among groups,there was no statistically significant difference in FPG,2h PG and Hb A1 c between the two groups after treatment（P>0.05）.（3）Related indicators of blood lipid and obesity: After treatment,total cholesterol（TC）and triglycerides（TG）in the two groups decreased compared with before treatment（P<0.05）.High-density lipoprotein（HDL-C）in the two groups increased prominently before treatment（P<0.05）.The difference was statistically significant.Low density lipoprotein（LDL-C）in the control group significantly decreased compared with before treatment,and there was no statistically significant difference in other indicators in the treatment group compared with before treatment（P>0.05）.There was no statistically significant difference in blood lipid-related indexes between the two groups after treatment（P>0.05）.After treatment,the body mass index（BMI）and waist circumference（WC）in the two groups were observably lower than those before treatment（P<0.01）.Comparing the treatment groups,the treatment group improved BMI level better than the control group（P<0.05）,and there was no obvious difference in WC between the two groups after treatment（P>0.05）.2 Intestinal flora data:lllumina PE250 sequencing showed no statistically significant difference in the total number of OTU in the two groups before treatment（P>0.05）.After treatment,the abundance and diversity of bacteria in the treatment group showed an increasing trend,while that in the control group showed a decreasing trend,and there was no significant difference between the two groups（P>0.05）.The characteristics of the intestinal flora of patients with obese T2 DM with phlegm turbid obstruction were Blautia,Escherichiashigella,Faecalibacterium,Bacteroides,and Subdoligranulum,etc,at the level of genus.After the compound intervention,the relative abundance of Bifidobacterium and Eubacteriumhalliigroup was significantly increased（P<0.05）,the relative abundance of Bacteroides and Faecalibacterium increased,and the relative abundance of Ruminococcus2 and Ruminococcusgnavusgroup was significantly decreased（P<0.05）.The relative abundance of Blautia and Roseburia decreased.3 Security index:After 12 weeks of treatment,there were no abnormalities in patients’ vital signs,blood routine,urine routine,fecal routine,liver and kidney function and electrocardiogram.Conclusion:（1）Hezhong Jiangzhuo Tiaotang Decoction,which is based on the legislation of "dryness and spleen strengthening,clearing and reducing turbidity",can reduce the blood glucose and lipid levels of obese T2 DM phlegm turbid obstruction patients and improve clinical symptoms.（2）Compound Hezhong Jiangzhuo Tiaotang Decoction have obvious shaping effects on intestinal flora:（1）Regulate the relative abundance and diversity of flora;（2）The relative abundance of Bifidobacterium and Eubacteriumhalliigroup was significantly up-regulated,and the abundance of Bacteroides and Faecalibacterium was increased.The up-regulated intestinal flora may reduce the blood glucose level by regulating the metabolites of short-chain fatty acids.（3）Compound may regulate the relative abundance of bacteria involved in lipid metabolism and reduce lipid level.After the compound intervention,the Bifidobacterium abundance was significantly upregulated,the Bacteroides abundance was increased,and the Roseburia relative abundance was decreased.Compound Hezhong Jiangzhuo Tiaotang Decoction may affect glucose and lipid metabolism by improving intestinal flora structure.（3）In this experiment,Hezhong Jiangzhuo Tiaotang Decoction have good safety. |
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