Clinical Efficacy And Mechanism Of Shenzhu Puren Decoction In Treating Gastrointestinal Dysfuction In Type 2 Diabetes Mellitus

Objective:Combining the theory of traditional Chinese medicine(TCM)and western medicine,to summarize the understanding of diabetic gastrointestinal dysfunction.The aim of this study was to discuss the clinical efficacy and mechanism of shenzhu puren decoction in treating gastrointestinal dysfuction in type 2 diabetes mellitus by clinical trial and animal experiment.Clinical trial aimed to evaluate the impacts on the glucolipid metabolism?insulin?insulin resistance index(IRI)?TCM syndrome score?Gastrointestinal symptom score?pepsinogen(PG)?Helicobacter pylori urease antibody?interleukin-6(IL-6)?tumor necrosis factor-alpha(TNF-a).Animal experiment aimed to observe the impacts on the glucose?insulin?IRI?IL-6?TNF-a?gastric emptying rate?small intestine propulsion rate.To explore the clinical efficacy and mechanism,so as to facilitate the further promotion of this prescription in clinical practice.Method:1 Clinical trial Ninety patients through introduction period who met the diagnosis criteria of gastrointestinal dysfuction in 2 diabetes mellitus and Spleen deficiency with dampness symdrome were randomized into two groups:the control group(n=45)and the treatment group(n=45).The treatment group was treated with basic therapy,repaglinide and shenzhu puren decoction,the control group was treated with basic therapy.and repaglinide.Two groups were observed for a course of 12 weeks.The observation indexes were as follows:1)patients'characteristics:age?sex?course of the disease?BMI.2)curative indexes:TCM syndrome score?Gastrointestinal symptom score.3)glycometabolism indexes:fasting blood glucose(FBG)?postprandial blood glucose(PBG)?glycosylated hempglobin(HbA1C)?fasting insulin concentration(FINS)?insulin resistance index(IRI).4)lipometabolism indexes:total cholesterol(TC)?triglyceride(TG)?high-density lipoproteincholesterol(HDL-C)?low-density lipoproteincholesterol(LDL-C).5)pepsinogen:pepsinogen?(PGI)?pepsinogen?(PG?)?PG?/?.6)helicobacter pylori urease antibody.7)inflammatory factors:interleukin-6(IL-6),tumor necrosis factor-alpha(TNF-?).8)safety indexes:?glutamic-pyruvic transaminase(ALT),glutamic oxalacetic transaminase(AST),serum creatinine(Scr)?incidence of hypoglycemia?adverse effects rate.2 Animal experiment Forty Wistar male rats were chosed,six rats were randomly selected as the normal control group.Another 34 rats were established as the model rats of diabetic gastrointestinal dysfuction by high fat diet and low-dosed STZ.All the experimental rats were devided into five groups,normal group(6),model group(8);Chinese medicine low-dose group(8);Chinese medicine middle-dose group(9);Chinese medicine high-dose group(9).Each group was fed by the corresponding drug dose for 8 weeks.To monitor the body weight?blood glucose collected from the tail vein?insulin?IL-6?TNF-? collected from femoral artery and evaluate IRI in each group.The stomach and small intestine were dissected to measure the gastric emptying rate and intestinal propulsion rate.Result:1 Clinical trial1)There was no statistically significant difference between two groups,concluding age?sex?course of disease?BMI prior to treatment(P>0.05).After the treatment,BMI was significantly decreased in treatment group(P<0.05).BMI in the treatment group was significantly lower than the control group(P<0.05).2)TCM syndrome score?Gastrointestinal symptom score:after the treatment,TCM syndrome score?Gastrointestinal symptom score were significantly decreased in both groups(P<0.05),and the results showed statistical differences between the two groups(P<0.05).Curative effect of TCM symptoms in the treatment group was significantly higher than the control group(P<0.05).3)Glycometabolism indexes:after the treatment,FBG?PBG?HbA1C?IRI were significantly decreased in both groups(P<0.05).FBG?HbA1C?IRI were showed statistical differences between the two groups(P<0.05).Curative effect of glucose in treatment group was significantly higher than the control group(P<0.05).4)Lipometabolism indexes:after the treatment,TC and LDL-C were significantly decreased in both groups(P<0.05);TG was significantly decreased in the treatment group(P<0.05);HDL-C was significantly increased in the treatment group(P<0.05).TC?LDL,C and HDL-C were showed statistical differences between the two groups(P<0.05).5)PG:after the treatment,PGI and PG?/? were significantly increased in the treatment group(P<0.05),and the results showed statistical differences between the two groups(P<0.05).6)Helicobacter pylori urease antibody,after the treatment,positive rate was 13.64%and decreased significantly in the treatment group(P<0.05).Meanwhile,negative conversion ratio was 57.14%in the treatment group was significantly higher than the control group(P<0.05).7)IL-6,TNF-?:After the treatment,IL-6 and TNF-? were significantly decreased in both groups(P<0.05),and the results showed statistical differences between the two groups(P<0.05).8)Hepatic and renal function:after the treatment,there was no statistically significant difference in the two groups respectively,concluding ALT?AST and Scr(P>0.05).Meanwhile,the results showed no statistical difference between the two groups(P>0.05).9)There were no hypoglycemia occurred during the treatment in the two groups.Adverse reactions in the treatment group:1 case,the proportion was 2.3%.The results showed no statistical difference between the two groups(P>0.05).2 Animal experiment1)FBG,compared with the normal group,the other groups were significantly increased(P<0.01);After giving the drug,compared with the normal group,the other groups were significantly increased(P<0.05).Compared with the model group,FBG in all Chinese medicine treatment group were significantly decreased(P<0.05).2)FINS,compared with the normal group,the other groups were decreased,but there was no significantly difference between them(P>0.05).IRI,compared with the normal group,the other groups were significantly increased(P<0.05).After giving the drug,compared with the model group,IRI in all Chinese medicine treatment group were significantly decreased(P<0.05).3)IL-6?TNF-?,compared with the normal group,the other groups were significantly increased(P<0.05).After giving the drug,compared with the model group,IL-6 and TNF-? in both Chinese medicine high-dose group and middle-dose group were significantly decreased(P<0.05).Compared with Chinese medicine low-dose group,IL-6?TNF-? in both Chinese medicine high-dose group and middle-dose group were significantly decreased(P<0.05).4)Gastric emptying rate,compared with the normal group,the other groups were significantly decreased(P<0.05);After giving the drug,compared with the model group,both Chinese medicine high-dose group and middle-dose group were significantly increased(P<0.05);Compared with Chinese medicine low-dose group,both Chinese medicine high-dose group and middle-dose group were significantly decreased(P<0.05).5)Intestinal propulsion rate,compared with the normal group,the other groups were significantly decreased(P<0.05);After giving the drug,compared with the model group,both Chinese medicine high-dose group and middle-dose group were significantly increased(P<0.05);Compared with Chinese medicine low-dose group,both Chinese medicine high-dose group and middle-dose group were significantly decreased(P<0.05).Conclusion:1)Shenzhupuren decoction can lower glucose,improve insulin resistance and lipid metabolism,regulate the level of PGI.PGI/II,improve Helicobacter pylori urease antibody and decrease the level of IL-6?TNF-? in gastrointestinal dysfuction in type 2 diabetes mellitus and Spleen deficiency with dampness symdrome.In addition,shenzhu puren decoction has no obvious adverse reactions,is safe and effective.2)Shenzhu puren decoction can lower FBG,improve insulin resistance,decrease the level of IL-6?TNF-?,and promote gastric emptying and intestinal propulsion in the model rats in diabetic gastrointestinal dysfuction.