| Objective:To observe the clinical efficacy of Lianpeweendan decoction combined with metformin hydrochloride enteric-coated tablets in the treatment of type 2 diabetes mellitus of spleen deficiency and damp-heat type,and to explore the possible mechanism of action,so as to provide a new way of thinking for the treatment of diabetes mellitus by traditional Chinese medicine(TCM).Methods:66 patients with dampness-heat deficiency spleen type Xiaoke disease who met the inclusion criteria and confirmed the purpose and method of the trial and signed the informed consent form were randomly divided into two groups(33 cases each).On the premise of basic treatment,the control group was treated with metformin hydrochloride enteric-coated tablets,500 mg,3 times a day.On the basis of treatment in the control group,the treatment group was treated with Lianpeiwendan decoction,200ml water flushing twice a day,in the morning and evening,and the course of treatment was 8 weeks.The levels of FPG,2hPG,HbAlc,TC,TG,LDL-C in all patients before and after the trial were recorded,as well as the improvement of TCM symptoms.The statistical software SPSS20.0 was used to analyze the data,and the changes of the data before and after the test in the same group were compared,and the true and effective conclusions were obtained.Results:(1)After treatment,the level of FPG,2hPG,HbA1c,TC,TG,LDL-C and the clinical symptoms of TCM in all the patients were lower than those before the test(P<0.05).(2)After the experiment,the total efficacy of Lianpeweendan decoction combined with western medicine in reducing the total integral of TCM symptoms of FPG,2hPG,was87.1%,90.32%,83.87%,respectively.In the oral western medicine group,the total efficiency of reducing FPG,2hPG,was 87.1%,90.32%and 83.87%,respectively.The total efficacy of TCM symptom integral was 67.74%,67.74%,54.84%,respectively.There was significant difference between groups(P<0.05).(3)After the experiment,the curative effect of each single TCM symptom was compared among the groups,such as abdominal distension of chest and epigastric,head and body difficulty,not much thirst,bitter mouth,depressed heart and chest,rank sum test of urinal yellow dysmenorrhea(P<0.05),and the difference was statistically significant.Limb burnout,stool discomfort,rank sum test,P>0.05,there was no significant difference.(4)No significant adverse reactions were observed in all patients throughout the trial.Conclusion:(1)Both groups can effectively reduce the level of FPG,2hPG,HbAlc,TC,TG,LDL-C and improve the clinical symptoms of traditional Chinese medicine.(2)Lianpewendan decoction combined with metformin hydrochloride enteric-coated tablets was better than metformin hydrochloride group in improving the clinical symptoms of FPG,2hPG.(3)During the whole experiment,no adverse events occurred in the treatment group,which indicated that Lianpehendan decoction combined with Dimethyl Hydrochloride Shuangchang tablet was safe and reliable.The results showed that Lianpeweendan decoction combined with metformin hydrochloride enteric-coated tablets could effectively improve the clinical symptoms of FPG,2hPG,regulate internal environment,promote glucose metabolism,regulate spleen and stomach,and increase insulin sensitivity,etc.It provides theoretical support for the in-depth study of diabetes mellitus(type 2 diabetes mellitus)by traditional Chinese medicine(TCM). |