| Objective:Based on the real world study(RWS)method,this paper discusses the clinical efficacy of Zhizhehuore method in the treatment of type 2 diabetes mellitus(T2DM),and analyzes the prescription and medication rules of Professor Yue Rensong in the treatment of T2 DM patients with heat syndrome.Methods:Based on the data of T2 DM patients with heat syndrome treated by Professor Yue Rensong in the outpatient and inpatient departments from December 2018 to November2020,referring to the relevant guidelines and national standards,the primary and secondary disease standards of heat syndrome were screened out,and the case observation table was developed.Demographic data,height,weight,blood pressure,fasting serum insulin(FINS),fasting C-peptide,fasting blood glucose(FPG),2-hour postprandial insulin(2h INS),2-hour postprandial C-peptide,2-hour postprandial blood glucose(2h PG),glycosylated hemoglobin A1c(Hb A1c),total cholesterol(TC),triglyceride(TG),high density lipoprotein cholesterol(HDL-C),low density lipoprotein cholesterol(LDL-C),blood urea nitrogen(BUN),serum creatinine(Scr),blood uric acid(BUA),alanine aminotransferase(ALT),aspartate aminotransferase(AST),urinary albumin-to-creatinine ratio(UACR),primary and secondary symptoms of traditional Chinese medicine and prescriptions of Chinese and Western medicine of the patients were collected comprehensively.To explore the therapeutic effect and characteristics of Professor Yue Rensong’s application of Zhizhehuore method in the treatment of T2 DM,the database was established and SPSS 26.0 was used for statistical analysis.Results:A total of 137 patients with 548 records were included in this study.In the first month of treatment,the effect of zhizhehuore method on reducing FPG was not obvious,but in the second and third month,it had obvious effect on reducing FPG.The Zhizhehuore method has a definite effect on reducing 2h PG.In normal weight,overweight and obese patients,Zhizhehuore method has better effect on reducing FPG.The effect of TCM combined with western medicine in reducing Hb A1 c was better than that of pure TCM group,and the difference was statistically significant(P<0.05).The Zhizhehuore method did not improve the insulin and C-peptide Release function.In 20 men with insulin resistance index≥4.31 and 17 women with insulin resistance index≥4.51,HOMA-IR was significantly improved after treatment with Zhizhehuore method(P<0.05).Compared with 4th month,TG,LDL-C and HDL-C were improved in different degrees,but the difference was not statistically significant(P>0.05).The BMI of overweight and obese patients improved slightly in 0 month and3 rd month after treatment,and the difference was statistically significant(P<0.05).There was no significant difference in UACR before and after treatment(P<0.05).BUA was significantly improved in 0 month and 3rd month(P<0.05).BUN,Scr,ALT,AST of patients had no significant changes in 0 month and3 rd month.During the 4-month observation period,there was no effect of traditional Chinese medicine on liver and kidney function.In the evaluation of clinical syndrome efficacy,cured patients accounted for 13.86%,markedly effective 27.00%,effective 57.66%.In TCM syndrome score,0 month vs.1st month,1st month vs.2nd month,2nd month vs.3rd month,the symptoms of patients were significantly improved.In terms of the main symptoms,yellow fur,red tongue,thirst,overeating,constipation,sticky and smelly stool,yellow urine,fatigue,abdominal distension,diarrhea,halitosis,sweating,upset and insomnia were all improved.The remission rate of thirst was the highest,followed by overeating,abdominal distension and halitosis.From high to low,the frequency of TCM was Coptis,Scutellaria,licorice,Pueraria,gypsum,phellodendron,gardenia,litchi seed,trichosanthin,reed root,etc.From high to low,the prescriptions were Gegen Qinlian decoction,Sanhuang Gypsum decoction,Yunu decoction,Gualou Muli powder,Yueju pill,Baihujiarenshen decoction,Xiebai powder,Huanglian Jiedu decoction,Sanhuang Xiexin Decoction,Huanglian Daochi powder,etc.From high to low,the use frequency of traditional Chinese medicine pairs were Scutellaria-Coptis,Gegen-Coptis,Coptis-Gardenia,Coptis-Rhubarb,Trichosanthis-Oyster,Paeoniae Radix Rubra-Rhubarb,Atractylodes-Gypsum,etc.Conclusion:From the data of RWS,Zhizhehuore method can significantly improve the clinical symptoms of patients,improve the quality of life,effectively reduce FPG,2h PG and Hb A1 c,improve insulin resistance,reduce BMI,and reduce TC and BUA to a certain extent.Pure TCM in the treatment of early T2 DM in the hypoglycemic effect is not inferior to western medicine treatment,in improving the clinical symptoms of patients is significantly better than western medicine treatment. |