Clincal Observation Of Lianchen Decoction In The Treat Of Obese T2DM Patients And Its Effect On NF-κB P65 And TNF-α

Objective:To observe the clinical efficacy of Lian Chen Decoction in the treatment of obese T2DM(phlegm-damp internal obstruction evidence)patients and its effect on NF-κB p65 and TNFα,and to explore its possible mechanism of action,hoping to provide reliable clinical data to support the treatment of obese T2DM with Lian Chen Decoction.Methods:Sixty-four patients with obese T2DM with phlegmdamp internal obstruction who met the inclusion criteria and attended the outpatient clinic of the Department of Endocrinology,The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine from February 2022 to October 2022 were randomly divided into 32 patients in the control group and 32 patients in the treatment group.Patients in both groups were given basic treatment such as diabetes education,diet and exercise,and metformin hydrochloride tablets were given to the control group,while patients in the treatment group were given Lian Chen Tang and metformin hydrochloride tablets for a 12-week treatment period.The patients were compared before and after treatment for changes in TCM syndrome score,obesity indexes(BMI,WC,weight),glucose metabolism indexes(FBG,2hPG,HbA1c),lipid metabolism indexes(TG,TC,LDL-C),insulin-related indexes(FINS,HOMA-IR),inflammation indexes(NF-κB p65,TNF-α)and safety indexes.Results:1.Number of patient cases completed:64 cases of obese T2DM patients with phlegm-damp internal obstruction were enrolled,among which 2 cases in the control group and 1 patient in the treatment group withdrew during the trial and were regarded as detached cases,and the final statistically treated patients were 61 cases.2.General data:There was no significant difference between the two groups in terms of gender,age,and duration of disease by statistical analysis(P>0.05),and they were comparable.3.Chinese medicine evidence points:The TCM evidence scores were comparable between the two groups of patients before treatment(P>0.05);after treatment,the Chinese medicine evidence points of patients in both groups were lower than before(P<0.01);the treatment group improved significantly better than the control group(P<0.0 1).4.Obesity indexes:BMI,WC and weight of patients in both groups were comparable before treatment(P>0.05);after treatment,BMI,WC and weight of patients in both groups decreased compared with those before treatment(P<0.05),the improvement in the treatment group was better than that in the control group(P<0.05).5.Glucose metabolism indexes:FBG,2hPG and HbA1c were comparable between the two groups before treatment(P>0.05);after treatment,FBG,2hPG and HbA1c decreased in both groups compared with those before treatment(P<0.01),and the improvement in the treatment group was better than that in the control group(P<0.05).6.Lipid metabolism indexes:TG,TC and LDL-C were comparable between the two groups before treatment(P>0.05);after treatment,TG,TC and LDL-C were lower in both groups than before treatment(P<0.05),and the treatment group improved better than the control group(P<0.05).7.Insulin-related indexes:FINS and HOMA-IR were comparable between the two groups before treatment(P>0.05);after treatment,FINS and HOMA-IR decreased in both groups compared with those before treatment(P<0.05),and the treatment group improved better than the control group(P<0.05).8.Comparison of inflammatory indexes:intra-group comparison between the two groups of patients before and after treatment,NF-κB p6 5 and TNF-α decreased,and the difference was statistically significant(P<0.01);inter-group comparison between the two groups of patients after treatment,the efficacy of the treatment group was better than that of the control group,and the difference was statistically significant(P<0.05).9.Comparison of the efficacy of Chinese medical evidence:5 cases were cured,15 cases were apparently effective,6 cases were effective,and 5 cases were invalid in the treatment group,with a total effective rate of 8 3.87%;2 cases were cured,8 cases were apparently effective,12 cases were effective,and 8 cases were invalid in the control group,with a total effective rate of 73.33%;the efficacy of the treatment group was better than that of the control group,and the difference was statistically significant(P<0.05).10.Comparison of the efficacy of Western medicine:①In terms of weight reduction,the treatment group showed efficacy in 14 cases,effective in 13 cases,invalid in 4 cases,with a total effective rate of 87.10%;the control group showed efficacy in 6 cases,effective in 17 cases,invalid in 7 cases,with a total effective rate of 8 3.3 3%;the efficacy of the treatment group was better than that of the control group,and the difference was statistically significant(P<0.05).②In terms of glucose lowering,there were 16 cases with apparent effect,13 cases with effective effect and 2 cases with invalid effect,with a total effective rate of 93.5 5%;there were 10 cases with apparent effect,11 cases with effective effect and 9 cases with invalid effect in the control group,with a total effective rate of 70.00%;the efficacy of the treatment group was better than that of the control group,and the difference was statistically significant(P<0.05).11.Safety:The four major vital signs of the patients in both groups were stable during the treatment,and no abnormalities were found in blood and urine routine,liver and kidney function tests,and no significant adverse reactions were observed in either group.Conclusion:1.Compared with metformin alone,Lianchen Decoction combined with metformin has better efficacy in the treatment of obese T2DM patients(phlegm-damp internal obstruction).2.Lianchen Decoction significantly improves the TCM symptoms,regulates the level of glucose and lipid metabolism,reduces body weight and increases insulin sensitivity in obese T2DM patients with phlegm-damp internal obstruction.3.Lianchen Decoction significantly reduce the levels of NF-κB p65 and TNF-α in obese patients with T2DM(phlegm-dampness internal obstruction syndrome),and reduce inflammation.4.Lianchen Decoction is safe and reliable in the treatment of obese T2DM patients(phlegm-dampness internal obst ruction syndrome),without toxic side effects.