Evaluation On The Curative Effect Of Jinfukang Oral Liquid Combined With Adjuvant Chemotherapy On The Treatment Of Postoperative ?b-?b Non-small Cell Lung Cancer: A Clinical Multicenter Randomized Controlled Trial

Objectives : To evaluate the curative effect of Jinfukang oral liquid in treating postoperative ?b-?b non-small cell lung cancer.This is the first time that circulating tumor cells(CTCs)have been used into the evaluation system on the curative effect of adjuvant chemotherapy.Secondly,we suppose that there's a potential connection between CTCs(circulating tumor cells)and tumor recurrence,which lead us to observe the real-world data to examine our hypothesis.Methods : In this multicenter Randomized controlled trial,122 postoperative ?b-?b non-small cell lung cancer patients were randomly divided into treatment group(n=59)and control group(n=63).The treatment group was administered Jinfukang oral liquid combined with adjuvant chemotherapy,while the control group was treated with only adjuvant chemotherapy.The treatment lasted for 4 cycles,and 21-28 days for 1cycle.CTCs(circulating tumor cells),Lung Cancer Quality of Life Question naire LC-43(EORTC QLQ-LC43),TCM syndrome scores,tumor marker,immunological indices and disease free survival rates of 6-12 months were observed before and after treatment.Results:(1)The number of CTCs decreased after treatment(P>0.05),while the control group increased slightly after 2 cycles of chemotherapy(P>0.05);the CTCs in the treatment group were slightly lower than the control group after 4 cycles of chemotherapy(P>0.05).(2)CTCs was positively correlated with CEA level(r=0.179,P<0.05);positively correlated with Cyfra211 level(r=0.181,P<0.05);positively correlated with Scc Ag level(r=0.239,P<0.05);CTCs was negatively correlated with CD3+ levels(r=-0.385,P<0.05).(3)After treatment,there were significant differences between two groups in physical function,cognitive function,emotional function,social function and role function(P<0.05);The improvement of domains in the symptoms of breathlessness,poor appetite and apnea in the treatment group were obviously reduced(P<0.05);while fatigue,breathlessness,nausea and vomit-ting and poor appetite in the control group were increased(P<0.05);there were significant differences between two groups in fatigue,poor appetite and breathlessness.(P<0.05);scores of overall health was significantly improved(P=0.026,P<0.05).(4)The the treatment group's ZPS score increased during the treatment,while decreased after 4 cycles of chemotherapy,and the control group continued to rise,the difference was statistically significant(P<0.05).(5)In terms of TCM syndrome,the treatment group's scores of fatigue,dry mouth and low fever were lower than the control group(P<0.05),in which the dry mouth and low fever scores were significantly lower(P <0.01).The therapeutic effect of TCM syndromes in the treatment group was better than that in the control group(P=0.000,P<0.01).(6)In terms of tumor maker,the treatment group's Scc Ag decreased significantly after treatment(P=0.001,P<0.05 P<0.01),and Scc Ag was significantly lower than the control group after treatment(P=0.029,P<0.05).(7)In terms of immunological indices,CD3+,CD4+,CD8+,CD4+/CD8+ were slightly higher after treatment,and the difference of CD4+ was statistically significant(P<0.05).(8)The disease-free survival rate of the treatment group was 98% and 92% at 6 and12 months,and the control group was 92% and 86%(p=0.461,p>0.05).(9)There was no significant difference between the treatment group and the control group in the side effects of chemotherapy(P>0.05).Conclusion:(1)Chemotherapy can reduce the number of CTCs in peripheral blood to a certain extent.Jinfukang Oral Liquid may further reduce the number of CTCs.(2)CTC can participate be used in early lung cancer prognosis.(3)Jinfukang Oral Liquid can improve the physical function,cognitive function,emotional function,social function and role function.it can also improve symptoms of breathlessness,nausea and vomit-ting,poor appetite and apnea,meanwhile it significantly improve overall health.(4)Jinfukang Oral Liquid can reduce patient ZPS score,but had no significant effect on KPS score.(5)Jinfukang Oral Liquid can improve the treatment group's TCM syndrome of fatigue,dry mouth and low fever.(6)Jinfukang Oral Liquid can reduce patient Scc Ag levels.(7)Jinfukang Oral Liquid can regulate immune function in patients.(8)It can prevent recurrence and metastasis to some extent by improve the disease-free survival rate of patients for 6 and 12 months.(9)Jinfukang Oral Liquid does not increase the side effects and has good safety.