| Purpose:To evaluate the clinical efficacy of self formulated "Fuzheng Sanjie Formula" in the diagnosis and treatment of patients with low and moderate risk pulmonary solitary ground glass nodules using integrated traditional Chinese and Western medicine,and to preliminarily explore its mechanism of action.Method:From August 2021 to August 2022,a total of 184 cases of low to moderate-risk pulmonary solitary ground-glass nodules were first found by computed tomography(CT)in the pulmonary nodule clinic of the Affiliated Hospital of Yangzhou University and they agreed to accept the study.Patients’ gender,age,smoking history,tumor and family history,size,density,location,shape,ProGRP,CEA,SCC,and CYFRA21-1 were collected.92 cases were randomly divided into treatment group and control group.The treatment group was treated with self prepared"Fuzheng Sanjie Formula" for 4 months,and rechecked after 1 month of drug withdrawal;The control group was not treated and was reexamined after 5 months.Use IBM SPSS Statistics 21.0 for statistical testing.The measurement data are expressed by mean ± standard deviation(x ±s),the data with normal distribution are tested by t test,and non normal data test by rank sum test;The number(n)and percentage(%)of counting data cases are expressed in chi square(χ2).Logistic regression analysis was used for multivariate analysis,using Pearson correlation analysis for continuous variables that are paired and have a linear relationship.P<0.05 indicates that the results are statistically different,single factor analysis can be relaxed to P<0.10 with statistical significance.Retrieve the effective components and corresponding protein targets of the basic drugs"Zidanshen","Zedoary Turmeric","Cat Claw Grass","Astragalus","Codonopsis pilosula",and"Chinese yam"of this compound through the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform(TCMSP platform)and the BenCaoZuJian(HERB platform),and determine the corresponding gene target of the protein target through the UniProt knowledge base.Find the predicted target gene of "palmary nodule" through the Omim database,then intersect the predicted genes and drug action targets.Finally use the David platform to conduct KEGG analysis on the intersection genes to find the metabolic pathway.Use the Cytoscape 3.10.0 software to construct a pulmonary nodule-pathway-target-component-drug network diagram.Result:1.The participants in this study were 184 patients with low to moderate risk solitary pulmonary ground-glass nodules,of whom 77 were male(41.85%)and 107 were female(58.15%).The overall prevalence was mostly female;The age distribution is from 27 to 87 years old,with an average age of 56.60 ± 11.73 years.The majority of middle-aged patients(50.0%)are between 45 and 59 years old,with 92 in total.The proportion of patients without a history of smoking was 80.98%,with a total of 149 cases,much higher than those with a history of smoking.A total of 175 patients had no previous history of cancer,accounting for 95.11%;among the 9 patients with a history of malignant tumors,there were 6 cases of lung cancer,1 case of breast cancer,1 case of prostate cancer,and 1 case of gastric cancer.Hairless spur sign and vascular sign were 153 cases(83.15%)and 179 cases(97.28%),respectively.A total of 147 patients(79.89%)had nodules with a maximum diameter of 5～10 mm.The nodules grew in the upper lobe in 92 cases(50.0%),followed by the lower lobe in 78 cases(42.39%).2.A total of 76 patients completed the entire research process,including 40 in the control group and 36 in the treatment group.The basic situation of the two groups of patients was compared through statistical research:in the treatment group,there were 10 males and 26 females,while in the control group,there were 16 males and 24 females(P=0.26>0.05);The average age of the treatment group was 46.86 ± 11.48 years old,while that of the control group was 47.73± 5.29 years old(P=0.68>0.05).There were 7 patients with a history of smoking in the treatment group and 7 patients in the control group(P=0.83>0.05);In the treatment group,11 patients had nodules with burrs,while in the control group,17 patients had burrs(P=0.28>0.05);In the treatment group,24 cases were initially diagnosed as low risk and 12 cases as medium risk for LCBP,while in the control group,28 cases were diagnosed as low risk and 12 cases as medium risk(P=0.76>0.05);The maximum diameter of initial diagnosis was 6.09 ± 1.70 mm in the treatment group and 6.34± 1.97 mm in the control group(P=0.56>0.05).It indicates that there are no significant statistical differences between the treatment group and the control group in terms of gender,age,smoking history,nodule size,and morphology,and further comparative studies can be conducted.3.In the treatment group,the risk before treatment was 27.61±19.43%,and after treatment was 24.54±15.92%(t=2.14,P=0.04<0.05),while in the control group,the risk for initial diagnosis was 22.51 ± 15.06%,and the risk for subsequent diagnosis was 24.36±16.94%(t=-1.27,P=0.21>0.05).The total effective rate of imaging and risk reduction in the traditional Chinese medicine treatment group were 50.0%and 75.0%,respectively,while the total effective rate of imaging and risk reduction in the control group were 25.0%and 40.0%,respectively.The effective rate in the traditional Chinese medicine group was significantly higher than that in the control group,with a statistically significant difference(P<0.05).No nodules disappeared in both groups.After treatment,CD4+and CD4+/CD8+in the traditional Chinese medicine group increased compared to those before treatment(P<0.05),while the proportion of NK cells did not significantly change(P>0.05).The index of T lymphocyte subsets in the control group did not significantly change.The proportion of B lymphocytes in both groups was significantly lower than that in the initial diagnosis(P<0.05).4.Select the effective components with high bioavailability of the six basic drugs of this compound("Zidanshen","Zedoary Turmeric","Cat Claw Grass","Astragalus","Codonopsis pilosula",and "Chinese yam"),and obtain a total of 257 corresponding non repetitive gene targets.Intersect with the predicted target genes of "Pulmonary Nodule",and obtain 10 common targets,namely CASP8,CAV1,EGFR,HMOX1,IRF1,MMP1,MPO,ERBB2,RB1,and TGFB1.After KEGG analysis of these intersection genes,32 metabolic pathways can be obtained.A pulmonary nodule pathway target component drug network map is constructed using Cytascape 3.10.0 software.The top 10 genes with visibility values are:PTGS2,NCOA2,EGFR,ERBB2,ADRB2,PGR,PTGS1,CHRM1,RXRA,and GABRA1.The core active component of this recipe is quercetin,and the main metabolic pathways are related to tumors.Conclusion:The self formulated "Fuzheng Sanjie Formula" can effectively reduce the risk of malignancy of low and medium risk solitary pulmonary ground-glass nodules,with the clinical manifestation of reducing the diameter of the nodules.The mechanism of action is preliminarily explored as follows:(1)It has a certain immunoregulatory effect,which can improve the immune status of patients by regulating the function of lymphocyte subsets,thereby potentially enhancing the ability of autoimmune clearance;(2)The core ingredient in the compound is quercetin,which mainly acts on tumor related pathways and inhibits tumor cell proliferation. |
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