| Objective: Through randomized and controlled clinical trials,the effect of Yiqi Yangyin Jiedu Formula on immune function of patients with early stage lung cancer after postoperative adjuvant chemotherapy was observed,and the metabolic regulation effect of Yiqi Yangyin Jiedu Formula on patients with early lung cancer was explored.Methods: Collected 34 cases of stage Ib – Iib adenocarcinoma lung cancer with syndrome of Qi and Yin deficiency patients in Longhua Hospital?Chest Hospital and Huadong Hospital from June 2017 to December 2018 are randomized divided into two groups:18 cases of the traditional Chinese medicine(TCM)+ chemotherapy group(Yiqi Yangyin Jiedu Formula plus chemotherapy)and 16 cases of chemotherapy group(chemotherapy alone),21 ? 28 days for a cycle,treatment of four cycles.The short-term efficacy,tumor markers,changes of cellular immune function and improvement rate of TCM symptom score of the two groups were observed.Adverse reactions after chemotherapy,including bone marrow suppression,gastrointestinal reactions and hepatorenal function,were monitored in both groups.In 60 cases of healthy people as control,the use of ultra high performance liquid chromatography tandem mass spectrometry(ultra-performance liquid chromatography coupled to tandem mass spectrometry,UPLC/MS/MS)technology based on two groups of patients before and after a period of treatment serum samples of amino acids,organic acids,fatty acids and sugar metabolism analysis,Yiqi Yangyin Jiedu Formula treatment of early lung cancer patients potential effective substance.Results: The 34 patients included in this study were followed up to April 30,2019,All the 34 patients completed 4 cycles of treatment,and no recurrence or metastasis was found.There were significant differences in the serum CD3+,CD4+,ratio of CD4+/CD8+ and NK cell activity between the two groups before and after treatment(p<0.05).With extending the courses,the serum CD3+,CD4+,ratio of CD4+/CD8+ and NK cell activity trend to rise in the TCM + chemotherapy group(p>0.05),while the serum CD3+,CD4+,ratio of CD4+/CD8+ and NK cell activity trend to downwards in the chemotherapy group(p>0.05).CA125 and CEA in the two groups were significantly different after 1 cycle and 4 cycles of treatment than before(p<0.01).With extending the courses,CA125 in the TCM+chemotherapy group decreased significantly(p<0.05),and CA125 in the chemotherapy group decreased first and then increased(p<0.05).CEA increased first and then decreased in both groups after internal treatment,and there was no significant difference between the two groups(p>0.05).There was no significant difference in CYFRA21-1 and SCC between the two groups(p>0.05).After 1 cycle of treatment,the total effective rate of the TCM+chemotherapy group was significantly higher than that of the chemotherapy group(p<0.05).After 4 cycles of treatment,the significant efficiency and total effective rate in the TCM+chemotherapy group were significantly higher than those in the chemotherapy group(p<0.05).In terms of adverse reactions,there was no significant difference between the two groups after 1 cycle after treatment(p>0.05).After 4 cycles,the incidence of nausea,vomiting and constipation in the TCM+chemotherapy group was significantly lower than that in the chemotherapy group(p<0.05).The incidence of IVeucopenia was lower in the TCM + chemotherapy group than in the chemotherapy group(p<0.05).In terms of metabolomics,a total of 43 different metabolites(p<0.05)were found in the disease group and the healthy group,respectively amino acids,fatty acids and organic acids,indicating their metabolic disorders.Indole-3-hydroxylic acid,succinic acid,glycine proline,hydroxypropionic acid,methylmalonic acid and other 5 different metabolites were found in the TCM+chemotherapy group before and after treatment.In addition to indole-3-hydroxylic acid,the concentration of other metabolites was significantly decreased compared with that before treatment(p<0.05).Conclusion:(1)Yiqi Yangyin Jiedu Formula can enhance activation of helper T-cell(CD3+?CD4+),ratio of CD4+/CD8+ and NK-cell activation,and regulate immune function in patients,stage IB to IIB non-small-cell lung cancer,treated with chemotherapy.(2)Yiqi Yangyin Jiedu Formula can alleviate side effects of chemotherapy,and improve Quality of Life of patients with completely resected stage IB to IIB non-small-cell lung cancer.(3)Our study reveals preliminarily metabolomics characteristics of patients with stage IB to IIB non-small-cell lung cancer: it presents metabolic disorder of amino acids,organic acids and fatty acids.(4)Yiqi Yangyin Jiedu Formula may participate in process of intervening tumor cell glycolysis,regulate energy metabolism of tumor cells,and balance metabolic disorder of patients with stage IB to IIB non-small-cell lung cancer. |
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