| Objective: we want to further explore the effect of "Yiqi-yangyin-tiaotangyin " in improving the metabolic disorders of the type 2 diabetes mellitus(T2DM)by observing the clinical curative effect of "Yiqi-yangyin-tiaotangyin " on syndrome of deficiency of qi and yin of T2 DM to facilitate the in-depth development of clinical research on TCM treat T2 DM.Methods: We randomly selected 66 patients with type 2 diabetes mellitus in the endocrinology clinic between May 2017 and November 2017.In this study,a randomized controlled method was used.The patients were randomly divided into treatment group and control group by computer random number generator,with 33 patients in each group.Under the premise of basic treatment,the treatment group was given "Yiqi-yangyin-tiaotangyin",and the control group was given the Xiaokewan.The patients had received a total of 12 weeks of treatment and we have compared the difference in symptoms integral,fasting plasma glucose(FPG),2 hours postprandial blood glucose(2hPG),glycosylated hemoglobin(HbA1C),insulin release test,c peptide release test,the indexes of insulin resistance(HOMA-IR),islet beta cells secrete index(HOMA-?),total cholesterol(TC),triglycerides(TG),high-density lipoprotein(HDL-C)and low density lipoprotein(LDL-C).In addition,we have separately compared the difference in standard deviation of blood glucose level(SDBG),postprandial blood glucose fluctuation range(PPGE)and maximum blood glucose fluctuation range(LAGE)after 2weeks treatment,4 weeks treatment,8 weeks treatmentand 12 weeks treatment.Finally,we haved used statistical methods to analyze these data to reach conclusions.Results:1.Disease efficacy comparison: The comparison of total effective comparison: after treatment,the total effective rate of the treatment group has been 90.3%,and the total effective rate of the control group has been90.0%,and the difference of curative effect between the two groups has been not statistically significant(P > 0.05).2.Comparison of blood glucose related indicators: intra-group comparison: after treatment,FPG,2hPG and HbA1 c in treatment group and the control group have been all decreased compared with those before treatment,and the difference analysis has been statistically significant(P<0.01).Comparison between groups: there has been no significant difference between the treatment group and the control group,and the difference analysis has been not statistically significant(P > 0.05).3.TCM symptom scores and syndrome efficacy comparison:intra-group comparison: the overall levels of TCM symptom scores in the treatment group and the control group both have been lower than before treatment,and the differences analysis have been statistically significant(P< 0.01).Comparison between groups: the level of TCM symptom scores in the treatment group has been lower than that in the control group,and the difference analysis has been statistically significant(P< 0.01).The clinical efficacy of TCM symptoms in the treatment group has been better than that in the control group,and the difference analysis has been statistically significant(P< 0.05).4.Comparison of islet function related indicators: insulin release test: intra-group comparison: after treatment,the levels of Fins and 1hIns in the treatment group and the control group were both higher than before treatment,and the differences analysis both have been statistically significant(P< 0.01).There both have been no significant change in the levels of secretion of 2hIns and 3hIns in the treatment group and the control group after treatment,and the difference analysis both have been not statistically significant(P> 0.05).Comparison between groups: there all have been no significant difference in the secretion of Fins,2hIns and3 hIns in the treatment group after treatment,and the differences all have been not statistically significant(P > 0.05).The level of 1hIns secretion in the treatment group has been higher than that in the control group,and the difference analysis has been statistically significant(P < 0.05).C-peptide release test: intra-group comparison: treatment group's fasting C-peptide level after treatment has been increased,and the difference analysis has been statistically significant(P < 0.05),treatment group's 1hours postprandial C-peptide level was increased,and the difference analysis has been statistically significant(P < 0.01),fasting c-peptide and 1hours postprandial C-peptide levels in control group both have been increased,the differences analysis both have been statistically significant(P < 0.05);After treatment,there all have been no significant change in the level of 2 hours postprandial c-peptide and 3 hours postprandial c-peptide secretion between the treatment group and the control group.The differences all have been not statistically significant(P > 0.05).Comparison between groups: the fasting c-peptide,2 hours postprandial c-peptide,3 hours postprandial c-peptide secretion level all have been no significant difference between treatment group and control group.And the differences all have been not statistically significant(P > 0.05);After treatment,the level of 1 hours postprandial c-peptide secretion level in the treatment group has been higher than that in the control group,and the difference analyze has been statistically significant(P< 0.05).5.HOMA-IR and HOMA-?comparison: intra-group comparison: the treatment group and the control group both have been improved compared with the before treatment,and the difference analysis has been statistically significant(P< 0.01).Comparison between groups: there has been no significant difference between the treatment group and the control group,and the difference analysis has been not statistically significant(P> 0.05).6.Comparison of lipid-related indicators: intra-group comparison:the TC,TG and LDL-C leves all have reduced compared respectively with before treatment in the treatment group after treatment.The differences analysis both have been statistically significant(P < 0.01).TC level has reduced compared with before treatment in the control groupafter treatment.The difference analysis has been statistically significant(P< 0.05).The TG and LDL-C levels have reduced compared with before treatment in the control group after treatment.The difference analysis has been statistically significant(P < 0.01).The HDL-C level have had no obvious improvement both in treatment group and control group after treatment compared with before treatment,and the difference analysis has been not statistically significant(P> 0.05);Comparison between groups:the level of TC secretion in the treatment group has been lower than that in the control group,and the difference analysis has been statistically significant(P < 0.05).The secretion of TG,HDL-C and LDL-C in the treatment group all have been not significantly differents from those in the control group,and the difference analyze all have been not statistically significant(P > 0.05).7.The indexes of blood glucose fluctuation comparison: intra-group comparison: the levels of SDBG,PPGE and LAGE in the treatment group and control group after 2 weeks treatment,4 weeks treatment,8 weeks treatment,12 weeks treatment all have decreased compared respectively with those before treatment,and the differences analysis all have been statistically significant(P < 0.01);Comparison between groups: the levels of SDBG,PPGE and LAGE after the treatment of 2 weeks in treatment group all have been higher than those in the control group,and the differences analysis all have been statistically significant(P< 0.05).There have been no significant differences of the levels of SDBG,PPGE,LAGE between treatment group and control group after 4 weeks treatment,and the differences analysis have been not statistically significant(P >0.05).The levels of SDBG,PPGE in treatment group all have been lower than those in the control group after 8 weeks treatment and 12 weeks treatment,the difference analysis all have been statistical significance(P< 0.01).The levels of LAGE in treatment group have been lower than those in the control group after 8 weeks treatment and 12 weeks treatment,the difference analysis both have been statistical significance(P< 0.05).8.The vital signs have been normal after 12 weeks of treatmenand in the two groups.The routine examinations of blood,urine and fecal all have been normal after 12 weeks of treatmenand in the two groups.Thefunction examinations of liver and kidney have been also normal after 12 weeks of treatment in the two groups.The electrocardiograms of patients have been not abnormal after 12 weeks of treatment in the two groups.Conclusion: "Yiqi-yangyin-tiaotangyin" can effectively lower blood glucose,improve clinical symptoms,improve islet function,improve dyslipidemia,reduce insulin resistance and reduce blood glucose fluctuation in patients who with syndrome of deficiency of qi and yin of type 2 diabetes mellitus and it is safe. |
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