Objective: To investigate the therapeutic effect of Qiwei Baizhu powder on T2 DM and to investigate the mechanism of TLR4/NF-κB.Methods: A total of 65 patients of spleen deficiency type 2 diabetes collected from November 2021 to November 2022 of the Department of Endocrinology of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine were randomly divided into two groups: control group and experiment group.The two groups carried out health education on diabetes in accordance with the Chinese Guidelines for Prevention and Treatment of Type 2 Diabetes.The control group was given basic hypoglycemic treatment.The experimental group was added with Qiwei Baizhu powder.The course of intervention in both groups is 4 weeks.Blood,urine,stool,ECG,hepatic and renal function were measured at 4 weeks,and the occurrence of adverse reactions was recorded.Blood samples were taken from both groups,and serum glucose(FPG),fasting insulin(FINS),lipopolysaccharide(LPS),TLR4 and NF-κB were determined.Before and after treatment,Calculate insulin resistance index(HOMA-IR)before and after treatment,TCM syndrome evaluation was carried out.All clinical symptoms were classified as mild,moderate,and serious.The major symptom was 0,2,4,6,and the secondary symptom was 0,1,2,3.Compare the changes of various symptom scores and total symptom scores.SPSS statistical software version 25.0 was used to statistically analyze the collected data,observe and analyze the clinical efficacy and safety of Qiwei Baizhu powder.Result:Among the 65 patients,61 patients completed the clinical efficacy observation,32 in experiment group and 29 in control group.Before treatment,there was no statistical difference in demographic characteristics(gender,age),general clinical data(current history and course of diabetes),and laboratory data between the two groups,which was comparable.There were no adverse reactions in both groups before and after treatment,and the three routine tests,electrocardiogram,liver and kidney functions were normal.1.Reduce the levels of FPG and HOMA-IR: After treatment,the FPG and HOMA-IR of the two groups were significantly decreased(P<0.05);After treatment,HOMA-IR was significantly different between the two groups(P<0.05),HOMA-IR decreased more significantly in the test group,and there was no significant difference in FPG level(P>0.05).2.Reduces levels of inflammatory factors : after 4 weeks of treatment,the levels of LPS,TLR4 and NF-κB in both groups were significantly reduced(P<0.05).Compared with the control group,TLR4 and NF-κB decreased significantly in the experimental group(P<0.05).There was no clear difference between the two groups in reducing LPS levels(P>0.05).3.Improve TCM syndrome: After treatment,the total score of TCM syndrome in both groups was significantly reduced(P<0.05),the decrease in the experimental group was greater than that in the control group(P<0.05).Of the 32 patients in the test group,2 were cured,17 were markedly effective,11 were effective,and 2 were ineffective,with a total effective rate of 93.75%;Of the 29 patients in the control group,0 were cured,0 were markedly effective,6 were effective,23 were ineffective,and the total effective rate was20.69%.The total effective rate of the test group was significantly higher than that of the control group(P<0.05).The total effective rate of the experimental group was significantly better than that of the control group(P<0.05).Except for the lack of obvious improvement in the symptoms of weakness of defecation,the other symptoms were improved(P<0.05),especially in improving the symptoms of abdominal distension after eating,lack of appetite,abnormal stool,fatigue,abdominal pain,light thirst,sallow complexion,and the efficacy of the experimental group was significantly better than that of the control group(P<0.05).Conclusion:1.Qiwei Baizhu powder can significantly reduce the levels of LPS,TLR4,NF-κB in patients with spleen deficiency T2 DM,reduce blood sugar,improve insulin resistance,reduce the medical syndrome score of patients,and improve the clinical symptoms of patients.2.According to the results of serum TLR4 and NF-κB changes,Qiwei Baizhu powder may improve patients’ symptoms and play a therapeutic role through inhibiting TLR4/NF-κB signal path activation. |