| Objective Type 2 diabetes mellitus is the main type of diabetes mellitus,the main cause of which is insulin resistance.Treating of insulin resistance and improving insulin sensitivity is the key to treat type 2 diabetes mellitus.In this study,a randomized controlled trial was conducted on 66 patients with type 2 diabetes with Shirekunpizheng,to study the efficacy and safety of Gegen Qinlian decoction combined with metformin in the treatment of it,and to preliminarily discuss its mechanism,so as to provide more data support for its clinical application.Methods(1)Subjects in this study were recruited from the Affiliated Hospital of Hubei University of Traditional Chinese Medicine--Hubei Provincial Hospital of TCM from October 2019 to September 2020.The 66 subjects were divided into experimental group and control group according to the random grouping principle.There were 33 subjects in each group.The general indexes(age,gender,course of disease,weight)and efficacy indexes(fasting plasma glucose,2-hour postprandial plasma glucose,Hb A1 c compliance rate,insulin action index,blood lipid,symptom score)of the subjects were compared before the trial,and the differences were not significant,then the trial was started.(2)The control group received basic treatment and oral metformin hydrochloride tablets(commercial name: Gvacil,specification: 0.5g/tablet,twice a day,1 tablet each time).The experimental group was additionally treated with Gegen Qinlian decoction(200ml each time,twice a day).The efficacy indexes were monitored,and efficacy indexes and the scores of symptoms were compared after 8 weeks,finally the curative effect was evaluated.(3)The liver and renal functions of the subjects were tested before and after the experiment.During the treatment,blood glucose was monitored once a week before sleep(11pm),the occurrence and treatment of adverse events were recorded,finally the safety was evaluated.Results(1)Comparison before treatment: there were no significant differences in age,sex,course of disease and body weight between the experimental group and the control group,and they were comparable.(2)the curative effect comparison in the group: after eight weeks of treatment,the fasting plasma glucose,2-hour postprandial plasma glucose,total cholesterol,triglyceride,low density lipoprotein cholesterol of experimental group were significantly lower than before,the insulin function index,Hb A1 c compliance rate,high density lipoprotein cholesterol increased obviously,the differences were statistically significant(P<0.05);In the control group,the fasting blood glucose,2-hour postprandial plasma glucose,the compliance rate of Hb A1 c and the insulin action index were significantly improved compared with those before treatment,with statistical significance(P<0.05).There were no significant differences in total cholesterol,triglyceride,low density lipoprotein cholesterol and high density lipoprotein cholesterol(P>0.05).(3)curative effect comparison between groups: after 8 weeks of treatment,the fasting plasma glucose,2-hour postprandial plasma glucose,total cholesterol,triglyceride,and low density lipoprotein cholesterol of the experimental group were significantly lower than the control group.High density lipoprotein cholesterol,insulin function index,and the compliance rate of Hb A1 c were significantly higher than the control group.P<0.05,these differences were statistically significant.(4)Comparison of TCM syndrome scores: the total effective rate,clinical recovery,significant effective rate and effective rate in the control group were 54.55%,0,9.09% and 45.45%,respectively.The total effective rate,clinical recovery rate,significant effective rate and effective rate in the experimental group were 87.88%,12.12%,30.00% and 45.45%.The difference between the two methods was statistically significant(P<0.05).The effective rate of the experimental group was significantly higher than that of the control group.(5)Safety evaluation: The incidence of adverse events in the control group was 12.12%,and that in the test group was 9.09%,showing no significant difference(P>0.05).At the same time,there was no obvious abnormal assay index in liver and renal functions,and no obvious hypoglycemia,hypoglycemia reaction and hypoglycemia in the two groups.Conclusion Gegen Qinlian decoction combined with metformin can significantly improve the clinical symptoms of type 2 diabetes patients with Shirekunpizheng,and can significantly improve the symptoms of epigastric distention and tightness,drowsiness of the head and body,lethargy of limbs and unpleasant stool.Moreover,it can control blood sugar,improve Hb A1 c compliance rate,regulate blood lipids and improve insulin resistance.The effect is better than metformin alone,and it is safe without obvious side effects in clinical use. |
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