Study On The Short-term Efficacy And Safety Of Yifei Decoction Combined With EGFR-TKIs In The Treatment Of Advanced Non-small Cell Lung Cancer With Spleen Deficiency And Phlegm-dampness

Objective In this study,by observing Yifei decoction combined with EGFR-Tkis in the treatment of patients with advanced non-small cell lung cancer with spleen deficiency and phlegm-dampness,the short-term clinical efficacy and safety were explored to verify whether Yifei decoction combined with EGFR-Tkis could prolong the progressive-free survival,improve clinical symptoms and improve the quality of life of patients with advanced non-small cell lung cancer with EGFR-sensitive mutations.Methods A prospective clinical study was conducted in this study.A total of 70 patients who met the inclusion criteria were collected from Professor Chai kequn’s outpatient department and oncology ward in Zhejiang hospital.They were randomly divided into experimental group(n=35)and control group(n=35).Experimental group:EGFR-TKIs targeted therapy+Yifei decoction therapy;Control group:EGFR-TKIs targeted therapy.The progress-free Survival(PFS),tumor markers(CEA,CA125,CA199),physical status score(ECOG PS scoring standard),TCM syndrome scale score and safety status were analyzed and compared between the two groups.SPSS25.0 software was used to process and collect data for statistical analysis.T-test was used for measurement data conforming to normal distribution and homogeneity of variance,rank-sum test was used for non-conforming data,and Chi-square test was used for counting data.Survival data were described by Kaplan-Meier,LogRank test was used for comparison between the two groups,and Cox regression analysis was used to evaluate the influencing factors on survival time.Results 1.Comparison of general data:a total of 70 patients were included in this study,and 35 patients were randomly divided into experimental group and control group respectively.There were no significant differences in gender,age,clinical stage,surgical history,smoking history and physical status score before intervention between the two groups(all P>0.05).2.ECOG PS score:after 3,6 and 12 months after intervention,there was no significant difference between the two groups,showing no statistical difference.(all P>0.05).3.Progression-free Survival:(1)The mean progression-free survival of the experimental group and the control group was 19.36 months and 13.11 months,respectively,and the median progression-free survival was 18 months and 13 months,respectively,and the difference between the two groups was statistically significant(P<0.05).It is suggested that the Yifei decoction combined with EGFR-TKIs targeted therapy group had a longer median progression-free survival time than the EGFR-TKIs-targeted therapy group alone.(2)Univariate analysis suggested that the presence or absence of metastases,surgical history and treatment groupings may be factors affecting progression-free survival,and the differences were statistically significant(LogRank P<0.05).(3)Cox regression analysis suggested that metastasis,surgical history,and treatment groupings were independent risk factors affecting progression-free survival(P<0.05).The effect of metastases without metastases on progression-free survival was statistically significant(HR=0.36,95%ICO.12-1.07,P=0.01),and the effect on progression-free survival was statistically significant compared with participants with no surgical history(HR=2.10,95%IC 1.13-3.90,P=0.02).The effect of the control group on progression-free survival was statistically significant compared with the subjects treated with traditional Chinese medicine Yifei decoctiong synergistic targeted drugs(HR=1.79,95%IC 1.02-3.16,P=0.04).4.Tumor markers:After March,June and December after the intervention,there was no statistical difference between cea in the experimental group and the control group(P>0.05).The values of CA125 and CA199 in the experimental group decreased significantly after the intervention in March,June and December,and there was a statistical difference with the control group(P<0.05).5.TCM syndrome score:after 3,6 and 12 months of intervention,TCM syndrome score of the two groups decreased compared with before intervention,and there was a significant difference in TCM syndrome score of the experimental group compared with the control group(all P<0.05).After 3,6 and 12 months of intervention,the total effective rate of the experimental group was 71.4%,77.1%and 78%,while that of the control group was 31.5%,34.3%and 40%,which was significantly higher than that of the control group(P=0.04,P=0.01,P=0.02).6.Safety evaluation:there were no statistically significant differences in bone marrow suppression and liver and kidney function impairment between the two groups after intervention(P>0.05).The incidence of rash in the experimental group was lower than that in the control group after intervention,and the difference between the two groups was statistically significant:(χ2=4.06,P=0.04)There was no significant difference in the incidence of diarrhea between the two groups(P>0.05).Conclusion In this study,Yifei decoction combined with EGFR-TKIs can prolong the progression-free survival of patients with advanced NSCLC with EGFR-sensitive mutations,delay the process of drug resistance,significantly improve the clinical symptoms and improve the quality of life.