| ObjectiveThe purpose of this study is to observe and verify the clinical effect of a combination treatment of traditional Chinese medicine and western medicine for overweight and obesity Type 2 Diabetes having the pattern of "Deficient Qi and Yin,phlegm-heat combined blood stasis".Meanwhile, concerns on improving treatment safety and promoting patients' compliance. This study also provides a optimized and reasonable treatment protocols to a better treatment to promote patients' compliance.MethodAccording to the WHO diagnose and traditional Chinese Medicine dialectical standard,70 incipient T2DM patients were chosen from in-and-out patients coming from endocrinology department in the Chinese medical hospital of GuangDong Province from October of 2007 to October of 2008.These selected patients were randomly divided into 2 groups(Group A,B).After 2 weeks' foundational diabetic treatment,Group A was given Extent-release metformin and Acarbose in addition(35 patients,2 patients dropped out);Group B was given Extent-release metformin and Acarbose and a traditional Chinese medicine recipe nourishing Qi-Yin,clearing heat and dissolving phlegm and activating blood to resolve stasis additional(35 patients,1 patients dropped out),and all of the two groups separately received each kind of treatment mentioned above for 3 months.Sex,age,weight index of patients in each group were measured statistically,and there were no significant difference(P>0.05), which meant the comparison between groups.Observation indexes include clinical syndromes,fasting plasma glucose(FPG),2h plasma glucose(2hPG), glycosylated hemoglobin(HbAlc),fasting insulin,blood coagulation,blood lipid,BMI,waist circumference(WC),hip Circumference(HC),waisthip ratio(WHR),insulin resistance index(IR).The incidence of hypoglycemia,and patients'compliance were compared.Meanwhile,the change of general physical examination items such as three routine tests(Blood Routine Test,Urine Routine Test,Stool Routine Test),Hepatic and Renal Function,Electrical Cardiogram were observed before and after treatment. ResultsAfter 3 months'treatment,clinical symptom,FPG,2hPG,FINS, HbA1c,BMI,WC,HC,blood lipid and blood coagulation improve parentally comparing with pre- treatment(P<0.01 or P<0.05).Variation of observation indexes in B group pre-and-post treatment has significant difference comparing with A groups.In terms of the incidence of hypoglycemia there were no significant difference(P>0.05),patients'compliance,B groups have significant difference comparing with A group(P<0.01).The safety indexes demonstrated some differences before and after the treatment,there are some side effects by using Extent-release metformin and Acarbose and a traditional Chinese medicine recipe nourishing Qi-Yin,clearing heat and dissolving phlegm and activating blood to resolve stasis.Such as distension and belch.For overweight and obesity Type 2 Diabetes having the pattern of "Deficient Qi and Yin,phlegm-heat combined blood stasis",this combination treatment can obviously improve patients'clinical syndrome, improve hypercoagulability and hyperlipidemia status as well as decrease FPG, 2hPG,HbA1c,FINS,BMI,WC,HC,thus improve patients'living quality.When the method was used clinically,no adverse effect was reported.Therefore, the clinical use of qi-reinforcing and yin nourishing,heat clearing and phlegm dissolving and blood activating Chinese medicine is safe. |