Clinical Study Of Transdermal Administration Of Yi Qi San Jie Fang In The Treatment Of NSCLC With Deficiency Of Both Qi And Yin

Objective The aim of this study was to investigate the efficacy of transdermal Yi qi San jie Fang in the treatment of advanced NSCLC patients with deficiency of both Qi and Yin.In order to provide a certain clinical basis for the treatment of NSCLC with traditional Chinese medicine.Methods A prospective,single-center,randomized controlled study was conducted to randomly divide 102 patients into three groups according to the inclusion and exclusion criteria.All patients were treated with 21-day chemotherapy regimen according to CSCO.The control group was treated with chemotherapy alone.The treatment group was treated with directional drug permeation apparatus(Yi qi San jie Fang)on the basis of chemotherapy.The blank group was treated with directional drug permeation apparatus(blank patch)on the basis of chemotherapy.Two cycles of chemotherapy were observed and the indexes were evaluated at the beginning and end of clinical observation.A total of 96 cases were included in the study,and the related data were analyzed statistically.Results(1)TCM syndrome score: After treatment,the scores of TCM symptoms in the three groups were all lower than before,with statistical significance(P<0.05);after treatment,the scores of TCM symptoms in the three groups were significantly different,and the scores of TCM symptoms in the treatment group were significantly lower than those in the control group and the blank group,with statistical significance(P<0.05).(2)KPS score: After treatment,the KPS scores of the three groups were higher than before,with statistical significance(P<0.05);after treatment,the KPS scores of the three groups were significantly different,and the KPS scores of the treatment group were significantly higher than those of the control group and the blank group,with statistical significance(P<0.05).(3)EORTC score: After treatment,the total health status scores of the three groups were higher than those before treatment,the difference was statistically significant(P<0.05);the functional score of the treatment group was higher than that before treatment,while the symptomatic score was lower than that before treatment,the difference was statistically significant(P<0.05).In the control group,the functional score showed a downward trend with chemotherapy,while the symptomatic score showed an upward trend with statistical significance(P<0.05).In the blank group,except for the decrease of emotional score(P<0.05),there was no significant difference in other areas(P> 0.05).(4)Serum CEA value: After treatment,the serum CEA values of the three groups were significantly lower than those before treatment,with a significant difference(P<0.01).However,there was no significant difference in serum CEA and CEA decrease among the three groups(P>0.05).(5)Immunocyte: After treatment,The value of CD3+T,CD4+T,CD4+/CD8+ and NK cells in peripheral blood of the three groups decreased,while CD8+T increased,the difference was statistically significant(P<0.05).The CD3+T,CD4+T,CD4+/CD8+ and NK cell value of the treatment group were significantly higher than those of the control group,while the CD8+T cell value was lower than that of the control group,with statistical significance(P<0.05);the CD3+T,CD4+T,CD4+/CD8+value of the treatment group were significantly higher than those of the blank group,while the CD8+T cell value was lower than that of the blank group,with statistical significance(P<0.05).However,there was no significant difference in NK cell value between blank group and blank group(P>0.05).There was no significant difference in CD3 + T,CD4 + T.But the NK cell value was higher than that of the control group(P<0.05).(6)Safety index: In the treatment of transdermal drug delivery,only 2 patients developed mild skin itching,and the symptoms disappeared after local wiping with 75% alcohol.Therefore,it is safe and effective to consider transdermal administration of Yi qi San jie Fang.Conclusion Transdermal administration of Yi qi San jie Fang can alleviate the clinical symptoms,improve KPS score and quality of life after chemotherapy,and improve the cellular immune function of NSCLC patients with deficiency of both Qi and Yin,without obvious adverse reactions.