Objective:To observe the effect of combination of supplementing qi and nourishing yin method and chemotherapy on the disease-free survival(DFS)of patients with stage ?-?A stage non-small cell lung cancer(NSCLC)after operation.We hope we can get positive results to provide the basis and help for patients with stage ?-?A after NSCLC operation.Methods:This study was conducted by a prospective cohort study including outpatients who were admitted to Guang'anmen Hospital of China Academy of Chinese Medical Sciences and Cancer Hospital Chinese Academy of Medical Sciences from December 2014 to December 2016.According to whether or not to accept Traditional Chinese Medicine(TCM)as exposure factors,the whole patients were divided into Chinese combined Western medicine cohort and Western medicine cohort.A total number of 145 patients were enrolled in the study,with 5 shedding cases.Chinese combined Western medicine cohort were 67 cases,Western medicine cohort were 78 cases.The western medicine cohort was treated with 4 cycles of chemotherapy on the basis of the 2011 edition of the NSCLC clinical practice guidelines issued by NCCN.The western medicine treatment western medicine combining Chinese and Western medicine,Chinese medicine treatment is supplementing qi and nourishing yin method;recommend Chinese medicine:yifeiqinghua granules;recommended recipe:Shashen maimendong Decoction;symptomatic subtraction:Cough:add almond,Platycodon grandiflorum,Fritillaria,aster,liquorice etc.Hemoptysis:add agrimony,madder,Rhizoma imperatae,thistle,the size of lotus root charcoal,etc.Chest pain:C Hu.clematis root,white peony root,angelica,Radix Cynanchi paniculati chelidonic,etc.Chest water:add Tinglizi,Poria,Polyporus,Solanum nigrum,plantain,JiaoMu etc.Fever:Silver plus bupleurum,paeonol,Digupi,Artemisia.Anemarrhena etc.After the 4 course of treatment,the study got into the follow-up phase.The follow-up was up to June 30,2017.The follow-up was mainly by interview and telephone.The primary observational outcome is DFS,and secondary observation indicators includ quality of life,FACT changes,improvement of TCM symptom scores,changes of KPS scores and NCI adverse reactions.Result:1.Survival analysis:comparison between the Chinese and Western medicine cohort and the western medical cohort:There were 34(43.59%)cases of recurrence and metastasis in the western medicine cohort,and 18(26.87%)cases of recurrence and metastasis occurred in the combined Chinese and western medicine cohort.The two cohorts were compared by the X2 test.X2=12.30,P=0.036(P<0.05),the difference was statistically significant;the average disease-free survival time of the integrated Chinese and Western medicine cohort and western medicine cohort was 23.64 months and 19.18 months,respectively,by the Log Rank(Mantle-Cox)test.The two cohorts had X2=4.28 and P=0.039(P<0.05),and the difference was statistically significant.The multivariate regression results after Cox risk model showed that the cohort factor P value was 0.041(P<0.05),and the RR value was 0.544.2.KPS score changes:The second,third,fourth chemotherapy and the first,second,third,fourth,fifth,sixth follow-up of the two groups of KPS score scores were compared,P<0.05,and the difference was statistically significant;the second,third,fourth chemotherapy and the first,second,third,fourth,fifth follow-up,KPS score of the two groups compared with baseline,P<0.05.The difference was statistically significant3.TCM symptoms score changes:The first,second,third,fourth chemotherapy and first,second,third,fourth,fifth,sixth follow-up of two groups of TCM symptoms score were compared,P<0.05,the difference was statistically significant.The first,second,third,fourth chemotherapy and first,second,third,fourth,fifth,sixth follow-up of two groups symptoms score changes were compared,P<0.05,the difference was statistically significant.4.Changes in FACT scores:The first,second,third and fourth chemotherapy and the first.second,fourth,third,fifth,and sixth follow-up of the two groups of FACT scores were compared,P<0.05,the difference was statistically significant;The first,second,third,fourth chemotherapy and the first,second,third,fourth,fifth follow-up of the two groups compared FACT with baseline,P<0.05,the difference was statistically significant.5.Changes in adverse reactions of NCI:In The first,second,third and fourth chemotherapy,the total scores of NCI symptoms in the western medicine cohort were higher than those in the Chinese and Western medicine cohort.The Wilcoxon test showed that the P values were all<0.05,and the difference was statistically significant.Conclusion:For the postoperative patients with stage ?-?A NSCLC with deficiency of both qi and yin,the combination of traditional Chinese medicine and Western medicine combined has a better DFS than that of western medicine.It can improve the patient's physical condition,relieve clinical symptoms,improve quality of life,and reduce chemotherapy adverse reactions. |