| Objective: Based on the theory of "Fenxiao Zouxie",with the treatment principle of clearing heat,dispelling dampness and invigorating spleen and Tongli Sanjiao.To observe the clinical efficacy of metformin hydrochloride tablets combined with Huanglian Wendan Decoction in the treatment of type 2 diabetes mellitus(damp-heat trapped spleen evidence),and to evaluate its efficacy and safety.Methods: In this study,72 cases that met the inclusion criteria were selected,and according to the random number table grouping method,72 cases were divided into two groups,with 36 cases in each group,namely the control group and the treatment group.The cases in this study were all derived from patients diagnosed with type 2 diabetes(damp-heat trapped spleen evidence)in the outpatient clinic of the Hospital of Changchun University of Chinese Medicine from November 2021 to September 2022.In the control and treatment groups,metformin hydrochloride tablets and metformin hydrochloride tablets combined with Huanglian Wendan Decoction were applied to treat type 2 diabetes mellitus(damp-heat trapped spleen evidence)on the basis of basic treatment for 12 consecutive weeks.Before and after treatment,the TCM evidence score,fasting blood glucose,2h postprandial blood glucose,glycosylated haemoglobin,fasting insulin level and insulin resistance index were recorded and the data were statistically analysed using SPSS27.0 statistical software.Results: A total of 72 cases were selected for this study,and after removing the 6 cases that were shed,66 cases were eventually entered into the statistical analysis of the data,33 cases each in the control and treatment groups.The general data,TCM evidence points and relevant physical and chemical examination indexes were statistically analyzed between the treatment group and the control group before treatment,P > 0.05,not statistically significant,can be compared.Results before and after treatment were as follows:(1)The TCM syndrome scores,blood glucose,insulin resistance index,body mass index and blood lipid of the two groups before and after treatment were compared within the group,P < 0.05,which had statistical significance.The results showed that both groups had the effect of improving TCM syndrome,lowering blood glucose,improving insulin resistance,weight loss and lowering blood lipid.(2)After the treatment,the TCM evidence score,blood glucose,insulin resistance,body mass index and blood lipids of the treatment and control groups were compared and P < 0.05,which is statistically significant.This indicated that the treatment effect of the treatment group was higher than that of the control group.(3)After treatment,the efficacy of the treatment and control groups in reducing fasting blood glucose,2h postprandial blood glucose and total TCM symptom score were 87.88%,81.82%,84.85%,84.85% and 69.70%,63.64%,66.67%,45.46% respectively,comparing between groups,P < 0.05,which is statistically significant.(4)No serious adverse reactions occurred in the two groups during the treatment.Conclusion: Metformin Hydrochloride Tablets combined with Huanglian Wendan Decoction have good efficacy in the treatment of type 2 diabetes mellitus(damp-heat trapped spleen evidence)in terms of lowering blood glucose,improving insulin resistance,weight loss,lowering blood lipids and improving clinical symptoms in Chinese medicine,and safety events did not occur during the course of treatment.This indicates that its treatment protocol can be widely used in the clinic. |