Objective: To observe the clinical curative effect of Yiqi Huazhuo capsules in treating Qi-yin Deficiency and Phlegm stagnation syndrome of type 2 diabetes mellitus insulin resistance,evaluate its safety,and provide new ideas and methods for the differentiation and treatment of diabetes insulin resistance.Methods: Randomized parallel controlled trials were used.According to the inclusion criteria,120 patients with type 2 diabetes mellitus insulin resistance and Traditional Chinese medicine(TCM)syndromes with Qi-yin Deficiency and Phlegm stagnation syndrome were selected and randomly divided into Yiqi Huazhuo capsules group(abbreviated as treatment Group)and pioglitazone hydrochloride group(abbreviated as control group),60 cases in each group,both groups were given basic health care such as diabetes education,diet and exercise.On the basis of basic health treatment,the treatment group treated with Yiqi Huazhuo Capsules,the control group treated with pioglitazone hydrochloride tablets,for a total of 12 weeks.Observe the changes of clinical symptoms,syndrome scores,blood glucose,insulin,blood lipids,body mass index and other indicators of the two groups before and after treatment.All data were analyzed by SPSS 20.0.Results:Before the treatment,the gender,age,course of disease,and related efficacy indexes of the two groups were statistically analyzed and compared.The difference was not statistically significant(P>0.05),and they were comparable.After 12 weeks of treatment:1.Efficacy of TCM Syndromes: The total effective rate of TCM syndromes is87.9% in the treatment group and 62.7% in the control group.The efficacy of the TCM syndrome in the treatment group is significantly better than that in the control group(P<0.01);the TCM symptoms are significantly improved before treatment,which was better than that of the control group(P<0.05);the TCM syndrome scores were significantly lower than before treatment,which was significantly lower than that of the control group(P<0.01).2.Blood glucose,insulin and insulin sensitivity: About fasting blood glucose,2 hours’ postprandial blood glucose,glycosylated hemoglobin,the treatment group and control group were significantly lower than before treatment,and there was a statistically significant difference between the two groups(P<0.01).Comparison between groups of each index,no significant difference(P > 0.05).The fasting insulin level and insulin resistance index in the treatment group and the control group were significantly lower than before treatment,and there was a statistically significant difference between the two groups(P<0.01).The insulin sensitivity index of the treatment group and the control group was significantly higher than before treatment,and the difference between the two groups was statistically significant(P<0.05);there was no significant difference between groups(P>0.05).3.Blood lipids,body mass index: Serum triglycerides and low-density lipoprotein cholesterol were significantly lower in the treatment group and the control group than before treatment,and the difference between the two groups was statistically significant(P<0.05).The total cholesterol in the treatment group was significantly lower than before treatment(P<0.05),and the treatment group was significantly lower than the control group(P<0.05).the body mass index of the treatment group was significantly lower than before treatment,and the difference between the group was statistically significant(P<0.05);The body mass index of the control group had no significant change compared with that before treatment,and there was no significant difference between groups(P>0.05).The weight of patients in the treatment group decreased significantly,which was better than that in the control group(P<0.05).4.Safety: No significant adverse reactions occurred in both groups during the treatment period.Conclusion: The Yiqi Huazhuo capsules have better clinical symptoms and efficacy than the pioglitazone hydrochloride group in patients with Qi-yin Deficiency and Phlegm stagnation syndrome of type 2 diabetes mellitus insulin resistance;Yiqi Huazhuo capsules significantly reduced blood sugar and blood lipids,improved insulin resistance,reduced weight,no obvious adverse reactions. |