| Objectives To observe the clinical efficacy and safety of Taohe Zhuling Decoction in the treatment of T2 DM patients with damp heat injury with Yin and blood stasis syndrome,and to explore its mechanism.Methods 70 T2 DM patients with damp heat injury with Yin and blood stasis syndrome were randomly divided into control group and experimental group,with 35 cases in each group.The control group was treated with metformin hydrochloride tablets,and the experimental group was treated with Taohe Zhuling Decoction on the basis of the control group.The treatment cycle was 12 weeks.The levels of blood glucose metabolism(including fasting blood glucose(FPG),2-hour postprandial blood glucose(2h PG),glycosylated hemoglobin(Hb A1c)),insulin resistance(including fasting insulin(FINS),insulin resistance index(HOMA-IR)),inflammation(including high-sensitivity C-reactive protein(hs-CRP),interleukin-6(IL-6)),blood lipid(including triglyceride(TG),total cholesterol(TC),Low density lipoprotein cholesterol(LDL-C),high density lipoprotein cholesterol(HDL-C)),body mass index(BMI),single and total scores of TCM syndromes,safety indicators(including liver function and renal function).The clinical efficacy was evaluated by comparing the blood glucose metabolism index,insulin resistance level,blood lipid metabolism index and TCM syndrome score between the two groups;To explore its mechanism through inflammatory indexes;The effect on the body weight of patients was observed by comparing body mass index(BMI);The safety was preliminarily evaluated by comparing the functions of liver and kidney.SPSS 25.0 was used to analyze the data.Gender was counted by chi square test;The course of disease and the integral of single TCM syndrome are quantitative data and do not accord with the normal distribution,which is tested by rank sum test;Age,blood pressure,FPG,2h PG,Hb A1 c,FINS,HOMA-IR,hs CRP,IL-6,TG,TC,LDL-C,HDL-C,BMI and total score of traditional Chinese medicine syndrome were measured and accorded with normal distribution,which is tested by t-test;The curative effect of TCM syndrome is grade data,which is tested by rank sum test.Results One case was eliminated in the experimental group,2 cases fell off in the control group,and 67 cases were actually completed,including 34 cases in the experimental group and 33 cases in the control group.1 There was no significant difference between the two groups in general data such as gender,age and course of disease(P > 0.05),and the test was comparable.2 Blood glucose level: After treatment,FPG,2h PG and Hb Alc in the two groups were significantly lower than those in the previous group(P < 0.05),and the test group was significantly better than that in the control group(P < 0.05).3 Insulin resistance level: After treatment,FINS and HOMA-IR in the two groups were significantly lower than those in the previous group(P < 0.05),and the test group was significantly better than that in the control group(P < 0.05).4 Inflammatory level: After treatment,hs-CRP and IL-6 in the two groups decreased significantly compared with the previous group(P < 0.05),and the experimental group was significantly better than the control group(P < 0.05).5 Blood lipid level and BMI:After treatment,TG,TC and LDL-C of the two groups decreased significantly(P < 0.05) and HDL-C increased significantly(P < 0.05).The experimental group was significantly better than the control group in reducing TC and LDL-C(P < 0.05),and had no significant advantage in reducing TG and increasing HDL-C(P > 0.05);After treatment,the BMI of the two groups decreased significantly(P < 0.05),and there was no significant difference between the two groups(P > 0.05).6 Curative effect of TCM syndrome: After treatment,the total score of TCM syndrome in the two groups decreased significantly compared with the previous group(P < 0.05),and the experimental group was significantly better than the control group(P < 0.05);The total effective rate of TCM syndrome in the experimental group(91.18%)was significantly better than that in the control group(63.64%)(P < 0.05).7 During the test,the liver and kidney functions of the two groups were not significantly abnormal,and there was no significant difference between the two groups(P > 0.05).Conclusions Taohe Zhuling decoction can reduce the level of glucose and lipid metabolism,insulin resistance,hs-CRP,IL-6 and BMI in T2 DM patients with damp heat injury Yin clip blood stasis syndrome,and can improve the clinical symptoms of patients.There are no obvious toxic and side effects during this trial,and the safety is good.Figure 0;Table 16;Reference 93... |
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