| Objective: To observe and evaluate the clinical efficacy of ba wei qidan capsule combined with insulin pump in the treatment of patients with newly diagnosed type 2diabetes with qi and yin deficiency and its effect on the cytokine spexin(SPX),to explore the mechanism of its action in the treatment of newly diagnosed T2 DM,and to provide new ideas for the prevention and treatment of T2 DM.Methods: A total of 64 cases of newly diagnosed T2 DM with qi and Yin deficiency were collected and sorted out according to the study requirements,and randomly divided into the treatment group and the control group(32 cases each).The control group was given the routine treatment of diabetes life guidance(diet + exercise)and intensive insulin pump treatment plan.Treatment group in the control group on the basis of the addition of eight wei qidan capsules(4 pills/time,3 times/day,oral),observed for 2 weeks.The changes of efficacy indexes(blood glucose and lipid indexes,islet cell function and resistance index,insulin dosage,hypoglycemia frequency,serum spexin level,TCM syndrome score)were compared between the two groups before and after treatment,and safety indexes were detected.Results:(1)Comparison of blood glucose indexes: After treatment,FPG,2h PG,and GA in two groups were significantly lower than before(P<0.01);Compared with the control group,the GA level of the treatment group decreased more significantly(P<0.05),while there was no difference between the two groups in FPG and 2h PG(P>0.05).(2)Comparison of blood lipid indicators: After treatment,TG,TC,LDL-C were lower in the two groups than before(P<0.05),HDL-C in both groups increased compared with the previous(P<0.05);Compared with the two groups,the reduction of TG,TC,LDL-C and the increase of HDL-C in the treatment group were more significant(P<0.05).(3)Comparison of islet cell function and resistance index: After treatment,HOMA-?in both groups increased(P<0.01),HOMA-IR in both groups was lower than before(P<0.01);Compared with the two groups,the increase of homa-nm and the decrease of homa-ir in the treatment group were more significant(P<0.01).(4)Comparison of insulin dosage,blood glucose compliance time,and hypoglycemia times: In the 2 weeks of treatment,compared with the two groups,the treatment group had less time to reach the standard of insulin dosage and blood glucose(P<0.01)and less hypoglycemia(P<0.05).(5)Comparison of serum spexin levels: After treatment,the serum spexin level was higher than before in both groups(P<0.01).Compared with the two groups,the serum spexin level of the treatment group was more significantly increased(P<0.01).(6)Comparison of TCM Syndrome Points and clinical efficacy: After treatment,the score of TCM syndromes in both groups was lower than that before(P<0.01);Compared with the two groups,the decrease was more significant in the treatment group(P<0.05);The total effective rate of both groups was 100%,but the significant efficiency of the treatment group was significantly higher than that of the control group(P <0.05).(7)Safety analysis: There were no obvious adverse reactions in the two groups of patients during the treatment.Conclusion: Bawei Qidan capsule combined with intensive insulin therapy has obvious clinical effects on patients with newly diagnosed T2 DM with qi-yin deficiency,compared with the control group,it can better regulate the level of glucose and lipid metabolism,improve islet cell function,reduce clinical symptoms,reduce insulin consumption,reduce blood glucose compliance time and the number of hypoglycemia;The mechanism may be to improve the level of cytokine spexin,affect the expression of spexin gene mediated by insulin receptors,improve the function ofislet cells from the cytokine pathway,participate in the metabolism of glucose and lipids,and regulate metabolic disorders,so as to achieve the purpose of treating the new diagnosis of T2 DM.Bawei Qidan capsules have been proved to be safe and effective through research,and can be used in clinic. |
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