Objective: To observe the clinical efficacy and physical changes of Buzhong Yiqi Pill in treating pre-diabetic patients with Qi deficiency under the guidance of the theory of constitution identification of traditional Chinese medicine(TCM),and to explore the therapeutic mechanism,so as to provide new ideas for the treatment of pre-diabetic patients with TCM.Methods: According to the results of oral glucose tolerance test(OGTT)and TCM constitution questionnaire,80 patients with pre-diabetes and Qi deficiency were selected as the subjects of this study.They were randomly divided into treatment group and control group with 40 cases in each group.The control group was given diet and exercise lifestyle guidance,while the treatment group was given the same lifestyle guidance as the control group,plus Buzhong Yiqi Pill.The course of treatment was12 weeks.After 12 weeks,the changes of fasting blood glucose(FPG),OGTT 2H blood glucose(OGTT2h PG),glycosylated hemoglobin(Hb A1c),insulin resistance index(HOMA-IR),islet β-cell function index(HOMA-β),body mass index(BMI)and Qi deficiency constitution integral were compared before and after treatment.The data were analyzed statistically to evaluate the therapeutic effect.Result: After 12 weeks,37 cases were effective in the treatment group and 39 cases in the control group.FPG,OGTT2 h PG,HOMA-IR and Qideficiency constitution integral of the two groups were lower than before treatment,with statistical significance(P< 0.05);HOMA-β was higherthan before treatment,with statistical significance(P<0.05);Hb A1 c and BMI were lower than before treatment,but there was no significant difference(P > 0.05).The treatment group was superior to the control group in reducing FPG,with statistical significance(P < 0.05);the treatment group was superior to the control group in raising HOMA-β and reducing Qi deficiency constitution integral,with statistical significance(P < 0.01);while there was no statistical difference in reducing OGTT2 h PG,Hb A1 c,HOMA-IR and BMI between the two groups(P>0.05).During the course of the test,no adverse reactions occurred in both groups.Conclusion: The overall curative effect of the treatment group is obviously better than that of the control group.The intervention of Buzhong Yiqi Pill on pre-diabetic patients with Qi deficiency can significantly reduce blood sugar level.It may be related to fundamentally correcting the predisposing constitution of Qi deficiency and improving the function of islet β cells.The application of Buzhong Yiqi Pill is safe and non-toxic,which is worthy of clinical recommendation. |