Objective: To observe the effect of Bufeixiaoji Decoction combined with EGFR-TKI on the efficacy,safety and the level of tumor markers in the first-line treatment of advanced non-small cell lung cancer,and to explore the relationship between the combined detection of serum CEA,CA125,CA199 and the efficacy of drugs.Methods: According to the inclusion criteria,90 cases of advanced non-small cell lung cancer patients with positive EGFR mutation and syndrome differentiation of deficiency of both qi and yin were collected from the outpatients and inpatients in the Oncology Department of the First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine from October 2017 to July 2018.They were randomly divided into treatment group and control group with 45 cases in each group.The treatment group was treated with Bufeixiaoji Decoction combined with EGFR-TKI,while the control group was treated with EGFR-TKI alone.The short-term efficacy,adverse reactions,TCM syndrome score,Progression-Free-Survival(PFS)and KPS score and the expression levels of serum CEA,CA125 and CA199 before and after the treatment were observed and compared between the two groups.Results:(1)Baseline data: there was no significant difference in age,sex,extrapulmonary metastasis,tumor classification and clinical stage between the treatment group and the control group(P > 0.05).(2)Short-term efficacy: the objective remission rate(ORR)of the treatment group was 53.3% and the disease control rate(DCR)was 86.7%.The ORR of the control group was 42.2% and the DCR was 88.9%.The difference of ORR between the two groups was statistically significant(P <0.05),but the difference of DCR was not statistically significant(P > 0.05).(3)TCM syndrome score: after treatment,the total scores of TCM syndrome in the two groups were improved(P < 0.05).The total effective rate was 73.33% in the treatment group and 24.44% in the control group.The treatment group was significantly better than the control group in the total score of TCM syndrome and the curative effect evaluation of syndrome(P <0.05).The difference was statistically significant(P < 0.05).(4)PFS: the median PFS was 15.3 months in the treatment group and 16.3months in the control group.There was no significant difference between the two groups(P > 0.05).(5)KPS score: after treatment,the KPS scores of the two groups were improved(P<0.05).The effective rate and stable rate of the treatment group were 53.33% and 93.33%,respectively,while those of the control group were26.67% and 80.00%,respectively.The difference was statistically significant(P < 0.05).(6)Safety: there were no serious adverse reactions related to this study in both groups.The incidence of rash and diarrhea in the treatment group was lower than that in the control group.The difference was statistically significant(P < 0.05).Conclusion: Bufeixiaoji Decoction combined with EGFR-TKI in the first-line treatment of advanced non-small cell lung cancer can improve the short-term efficacy,the TCM symptoms,the KPS score,and the quality of life.It can reduce the occurrence of adverse reactions,with high safety,which has better clinical application value.At the same time,it can reduce the expression level of serum tumor markers CEA,CA125 and CA199,and the combined detection can reflect the short-term effect of drug treatment to some extent. |