| Objective: Through the randomized controlled clinical study,the effect of Yiqi Yangyin Qingre recipe on the iron load of type 2 diabetes patients with deficiency of both qi and yin was evaluated,and its clinical efficacy and safety were evaluated.Methods: A total of 100 patients with type 2 diabetes with deficiency of both qi and yin who were treated at the outpatient department of the Endocrinology Department of the First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine from February 2019 to May 2020 were selected.They were randomly divided into control group and observation group with 50 cases each.The control group was given oral metformin hydrochloride sustained-release tablets,and the observation group was given Yiqi Yangyin Qingre recipe on the basis of the treatment of the control group.Both groups of patients were treated for 3 months.The body mass index(BMI),waist-to-hip ratio(WHR),serum ferritin(SF),fasting blood glucose(FBG),glycosylated hemoglobin(Hb A1c),fasting insulin(FINS),homeostasis model assessment of insulin resistance index(HOMA-IR),total cholesterol(TC),triglycerides(TG),low-density lipoprotein cholesterol(LDL-C)level and TCM syndrome scores were compared before and after treatment.At the same time,the medication and adverse reactions were recorded in detail at the time of consultation.In addition,analyze the correlation between the SF level before treatment and other observation indicators,and male and female patients were divided into quartile groups with 25%,50%,and 75% respectively according to the SF level,and the differences of various indicators under different quantile groups were observed before treatment.Results:(1)The patient’s SF level before treatment was positively correlated with age,WHR,FBG,Hb A1 c,FINS,HOMA-IR,TC,TG,LDL-C(P<0.01),and there was no statistical correlation with the length of the disease and BMI level(P>0.05).In addition,among male and female patients,the age,WHR,FBG,Hb A1 c,FINS,HOMA-IR,TG and LDL-C levels in the high-quantile group of SF levels were higher than those in the low-quantile group,and the difference was statistically significant(P<0.05).(2)After treatment,the BMI and WHR the two groups of patients were lower than before,and the BMI level of the observation group was lower than that of the control group,the difference was statistically significant(P<0.05).There was no significant difference in the WHR between the two groups of patients after treatment(P>0.05).(3)Compared with before treatment,the SF levels of the two groups of patients after treatment decreased,and the level of the observation group was significantly lower than that of the control group,the difference was statistically significant(P<0.01).(4)After treatment,the FBG and Hb A1 c levels of the two groups of patients were lower than before,and the Hb A1 c level of the observation group was lower than that of the control group.The difference was statistically significant(P<0.05).The FBG levels of the two groups were similar,and the difference was not statistically significant(P>0.05).(5)After treatment,the FINS and HOMA-IR levels of the two groups of patients were lower than before,and the FINS and HOMA-IR levels of the observation group were lower than those of the control group,the difference was statistically significant(P<0.05).(6)After treatment,the levels of TC,TG and LDL-C of the two groups of patients were lower than before treatment,and the levels of TC,TG and LDL-C of the observation group were lower than those of the control group,the difference was statistically significant(P<0.05).(7)After treatment,the clinical symptoms of the two groups of patients were improved compared with before,and the scores of TCM syndromes were lower than before treatment,and the scores of TCM syndromes after treatment of the observation group were lower than the control group,the difference was statistically significant(P<0.01).(8)During the study period,1 case fell out of the control group and 2 cases fell out of the observation group.There was no obvious abnormality in the safety index detection of the two groups of patients,and no serious adverse reactions or events occurred.Conclusion: 1.Elevated serum ferritin in type 2 diabetes patients may be closely related to the severity of high age,high waist-buttock ratio,high blood sugar,hyperlipids and insulin resistance.2.Yiqi Yangyin Qingre recipe could reduce the level of serum ferritin,relieve iron overload,reduce insulin resistance,and lower blood glucose and blood lipid in patients with type 2 diabetes mellitus of deficiency of both qi and yin.3.Yiqi Yangyin Qingre recipe could effectively relieve the clinical symptoms of type 2 diabetes patients with qi and yin deficiency,and improve the quality of life,and have good safety,which is worthy of clinical application and promotion. |
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