| Back Ground and ObjectiveThe morbidity of lung cancer is second place among malignant tumors, and about 80% of lung cancer patients are non-small cell lung cancer (NSCLC) Recently, NSCLC achieved great progress on diagnosis and treatment, however there are lots of advanced NSCLC patients. The mortality of NSCLC is still high.Bio-immunotherapy is a type of new therapy for malignant tumor after surgery, chemotherapy and radiotherapy, which is called the fourth kind of treatment of cancer, and become a research hotspot. DC-CIK cells are the killing activity of cytokine-induced killer (CIK) cells incubated with dendritic cells (DC), which got high anti-tumor activity. In clinical study, it present advantages of improve the patients’quality of life and prolong the survival period. It differs from cytotoxic drug in security, side-effects and time to effect. With the development of immunotherapy in clinical applications, more and more researcher realize that traditional response evaluation criteria in solid tumor can not reflects the effects of immunotherapy accurately. With the development of medical model, traditional bio-medical model was replaced by new bio-psycho-social medical model. The clinical outcome evaluation, especially those advanced tumor patients with pour performance and can not bear anti-cancer treatments, focus on not only tumor itself, but also patients’physiology, psychology, social health and tumor related symptoms.Advanced NSCLC patients especially those undergoing radiotherapy or chemotherapy patients are likely to present Traditional Chinese medicine (TCM) symptom type of deficiency of Qi and Yi. According to thousands of years TCM clinical practice, Sheng-Mai San got best effects of tonifying qi and nourishing yin and promoting the secretion of body fluid. Sheng-Mai San associated with remove blood stasis and clear away toxic materials method can reduce the symptom of deficiency of Qi and Yi, and improve advanced NSCLC patients’quality of life. In the study of TCM tumor therapy, more and more researchers got the point that it is necessary and important to establish TCM response evaluation system.Objective:1. To study the effects of Sheng-Mai San associated with DC-CIK immunotherapy on advanced NSCLC patients. Evaluate the quality of life as the clinical response evaluation method, and evidence for establishing scientific and effective TCM response evaluation system.2. To investigate clinical significance of T helper cell 17(Th17) in cancer patients undergoing TCM prescription Sheng-Mai San associated with DC-CIK immunotherapy, which maybe a clue of evaluating the immune function of immunotherapyMethods:1.60 advanced NSCLC patients with TCM symptom type deficiency of Qi and Yi were included in this study.15 patients were treated with DC-CIK immunotherapy as immunotherapy control group.30 patients were treated with TCM decoction Sheng-Mai San as TCM control group.15 patients were treated with both above two treatments as associated treatment group. Evaluate KPS, quality of life, symptom scale of TCM and immune function.2.30 cancer patients with TCM symptom type deficient of Qi and Yin were divided into treatment group and control group.15 cases were treated with TCM decoction Sheng-Mai San associated with DC-CIK immunotherapy as treatment group, while another 15 cases in which 2 cases lost were treated with DC-CIK immunotherapy only as control group. We also chose 8 cases of healthy adults as control group. Thl7 cells from human peripheral blood were performed by flow cytometry.Results:1. QLQ-C30 as endpoint to evaluate advanced NSCLC patients’ quality of life indicated that TCM and immunotherapy can both improve physical function, release symptom of fatigue and finally improve quality of life. TCM got a better effect than immunotherapy on releasing symptom of constipation, while less effect on improve the quality of sleeping.2. QLASTCM-GM as endpoint to evaluate quality of life indicated that associated treatment group got a better effect in the field of interaction of body and spirit (P=0.020). There is no difference among three groups in the field of interaction of human and environment. There is significant difference between before and after treatment. We got the conclusion that immunotherapy associated TCM can improve quality of life of advanced NSCLC patients better than use each only.3. In symptom scale of TCM field, associated treatment group got a better effect than TCM control group, and which got significant difference (P<0.05).4. Symptom scale of TCM is relevant with QLASTCM-GM in the field of interaction of body and spirit, and relevant with QLQ-C30 symptom of fatigue, short of breath, trouble of sleeping. The field of interaction of body and spirit of QLASTCM-GM is relevant with the field of physiology function of QLQ-C30.5. Level of Th17 cells from cancer patients, whose TCM symptom type were deficiency of both vital energy and yin was higher than health adult. Level of Th17 cells from cancer patients after immunotherapy was decreased, while Sheng-Mai San associated with immunotherapy decreased more.Conclusion:1. DC-CIK immunotherapy improves the quality of life of advanced NSCLC patients, and this effect increased when associated with TCM decoction Sheng-Mai San.2. There is a relationship between QLASTCM-GM and Symptom scale of TCM. It is valuable to further study QLASTCM-GM on quality of life evaluation. 3. Thl7 cells were the results of immune disorder of cancer patients. It can reflect the immunologic function of cancer patients, and maybe a new target to evaluate immunological function after immunotherapy.
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