| Objective:To observe the prevention and treatment of TCM therapy in preventing patients after radical surgery in stage Ⅲa NSCLC from recurrence and metastasis,and the role in improving quality of life,clinical symptoms,physical status and side effects,also to investigate their immune function in patients with reconstruction of regulatory targets,explain the underlying immunologic mechanisms.Methods:Using prospective,randomized study of methods,put 98 patients with stage Ⅲa NSCLC into treatment group(n=49)and control group(n=49)after radical by 1:1 randomization,TCM treatment group using TCM syndrome differentiation combined with adjuvant therapy;the control group using adjuvant therapy only.Disease-free survival was the primary outcome measures;1and 2 year disease-free survival rate,immune function(including peripheral blood T lymphocytes and the surface functional phenotype CTLA-4 and CD39 expression level);quality of life(EORCTQLQ-C30 and QLQ-LC13 quality of life scale),TCM clinical symptom score,performance status and adverse reactions were used as secondary observation indicators.The postoperative recurrence and metastasis,immune function,quality of life,TCM clinical symptoms,physical status and adverse reactions were observed.The relationship between the expression level of peripheral immune escape target of peripheral blood T lymphocytes and the recurrence and metastasis was analyzed.Result:(1)Disease-free survival:Before 2019-04-30,23 cases of the 49 in treatment group have occurred recurrence and metastasis;34 cases of the 49 in control group have occurred recurrence and metastasis.Treatment group m DFS is 24.77 months;control group m DFS is 16.00 months,the difference was statistically significant(P=0.026).1year disease-free survival rate was 73.5%vs.59.2%,2 years disease-free survival rate was 65.3%vs.46.9%,the difference was not statistically significant.(2)Immune function:The baseline was balanced between the two groups.After treatment,the CD3~+,CD4~+,CD4/CD8 and NK ranks were higher in the treatment group than in the control group,and the CD8~+rank was lower than the control group,among which the CD3~+,CD4~+and NK difference was statistically significant(P<0.01).Peripheral blood CD3~+CTLA4~+T lymphocytes(4.62±7.15%vs.1.81±3.04%)and CD39~+Treg cells(32.43±22.90%vs.13.54±13.57%)content were lower in treatment group but has no significant difference(P>0.05).(3)Quality of life:The baseline was balanced between the two groups.After treatment,the treatment group average scores in the functional areas of the EOTRC QLQ-C30 scale in terms of physical function,role function,cognitive function,and general health status was higher than the control group,and the difference in physical function and role function was statistically significant(P<0.01).The average scores except diarrhea of the treatment group was lower than that of the control group,among which the fatigue,nausea and vomiting,insomnia and loss of appetite difference was statistically significant(P<0.01).In the QLQ-LC13 scale,the average scores of the treatment group was lower than that of the control group,and the differences in hemoptysis and chest pain were statistically significant(P<0.05).(4)TCM clinical symptom scores:The baseline was balanced between the two groups.The TCM clinical symptom scores in treatment group significantly improved in 9 cases,partial improved in 22 cases,not improved in 15 cases,aggravation in 0 cases;The TCM clinical symptom scores in control group significantly improved in 2 cases,partial improved in 9 cases,not improved in 36 cases,1 case was aggravated,and the difference was statistically significant(P<0.01).After treatment,the total scores of the symptoms in the treatment group were lower than those in the control group,in symptoms of cough,chest pain,shortness of breath,chest tightness,fatigue,loss of appetite,spontaneous sweating,and five heart fever the differences was statistically significant(P<0.05).(5)Physical status score:The baseline was balanced between the two groups.The physical status score of treatment group improved in 9 cases,stabilized in 36 cases,and deteriorated in 1 case,and the improvement rate was 19.6%.The physical status score of control group improved in 2 cases,stabilized in 35 cases,deteriorated in 11 cases,and the improvement rate was 4.2%.The difference was statistically significant(P<0.01).(6)Adverse reactions:The incidence of adverse reactions in the two groups was 50.02%(25/49)vs.75.51%(37/49),and the difference was statistically significant(P=0.012).The main adverse reactions were myelosuppression,digestive tract reaction,liver dysfunction,rash and diarrhea.The incidence of myelosuppression was 36.73%(18/49)in the treatment group,which was lower than the control group 71.43%(35/49),and the difference was statistically significant(P=0.001).Conclusion:(1)TCM syndrome differentiation treatment has the effect of delaying recurrence and metastasis after radical resection of stage IIIa NSCLC;its mechanism may be to restore the body’s suppressed immunity by acting on the surface functional phenotypes CTLA-4 and CD39 of peripheral blood T lymphocytes,and reverse peripheral immune escape of stage IIIa NSCLC;(2)TCM syndrome differentiation treatment can improve the immunity function after radical surgery of stage IIIa NSCLC,and also reduce the level of CD3~+CTLA4~+T lymphocytes and CD39~+Treg cells;(3)TCM syndrome differentiation treatment can improve the quality of life and clinical symptoms of patients durning adjuvant therapy after radical surgery of stage IIIa NSCLC;(4)TCM syndrome differentiation treatment has a tendency to improve the physical condition of patients after radical surgery of stage IIIa NSCLC;(5)TCM syndrome differentiation treatment can alleviate the adverse reactions during the adjuvant treatment of patients after radical surgery of stage IIIa NSCLC;(6)Recommended TCM treatment as a standardized treatment protocols of adjuvant therapy in stage Ⅲa NSCLC after radical surgery. |
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