ObjectiveBased on the theory of TCM constitution,the clinical study of type 2 diabetes patients with Qi deficiency constitution was carried out,and the therapeutic effect and mechanism of Shuzheng Granule on type 2 diabetes with Qi deficiency constitution were discussed.To confirm the role of "regulating body and treating diseaseā,and provide a new idea for the prevention and treatment of type 2 diabetes from the perspective of traditional Chinese medicine.MethodsA single blind randomized controlled study was conducted to collect 72 outpatients and inpatients who met the diagnostic criteria for type 2 diabetes mellitus and the evaluation criteria for Qi deficiency constitution from January 2017 to January 2019 in the Endocrinology Department of Guangdong second TCM Hospital.They were divided into control group and treatment randomly.There were 36 cases in each groups.Two groups of patients were given basic treatment of regulating blood sugar and blood lipid,and the treatment group was given Shuzheng granule orally on this basis.The two groups were treated for 12 weeks.Observation and comparison of the two groups before and after treatment,the total score of physical fitness,TCM symptom score and changes in various indicators,to evaluate the efficacy.Results1.Blood sugar:Compared with before treatment,the FBG,2hBG and HbAlc decreased in different degrees after treatment in both groups(P<0.05 or P<0.01),but treatment group was superior than the control group in decreasing FBG,2hBG,HbAlc(P<0.05 or P<0.01).FINS and HOMA-IR improved in different degrees in both groups(P<0.05 or P<0.01).Compared with the control group,the improvement of FINS,HOMA-IR was more obvious in the treatment group(P<0.01).2.Blood lipid:compared with before treatment,TC,TG,LDL,HDL was improved in different degree after treatment in both groups(P<0.05 or P<0.01).but the effect of the treatment group on improving TC,TG,LDL and HDL was better than that of the control group(P<0.05 or P<0.01).3.TCM clinical efficacy:The treatment group effective rate was 88.89%,which was significantly superior to the control group(P<0.01);and the TCM syndromes in the two groups were lower than those before the control(P<0.01),but the treatment group was better than the control group(P<0.01)in improving TCM syndromes.4.Qi-deficiency constitution score:after treatment,the original score and transformation score of Qi-deficiency constitution in the two groups were decreased in varying degrees(P<0.01),but the original score of Qi-deficiency in the treatment group and the conversion score in the control group were decreased(P<0.01).In the improvement of fatigue,shortness of breath,cold,quiet,voice,sweating and other symptoms,the treatment group is better than the control group.(P<0.01).5.Safety:the Cr,BUN,AST,ALT of the two groups were in the normal range before and after treatment(P>0.05).Compared with the control group,the treatment group CR,BUN,AST,has no significant difference(P>0.05).The patients in both groups had good compliance and no adverse events.Conclusion:Shuzheng Granule has a good therapeutic effect on type 2 diabetes patients with Qi deficiency constitution.Compared with western medicine alone,Shuzheng Granule not only shows better curative effect on blood sugar and lipid,but also can effectively improve the clinical symptoms of type 2 diabetes mellitus in traditional Chinese medicine.It has definite curative effect and no adverse reactions.It is worthy of clinical promotion. |