Abstract:Objective To observe the clinical effect of Chinese medicine treatment of stage Ⅲb to Ⅳ non-small cell lung cancer (NSCLC) based on syndrome differentiation and disease differentiation. Methods A multicenter,prospective,randomized,controlled study was conducted.From October 2015 to January 2017,89 patients with stageⅢb to Ⅳ NSCLC with Qi and Yin deficiency were divided into treatment group (44 cases,treated with comprehensive treatment of Chinese medicine) and control group (45 cases,treated with chemotherapy alone).The control group received platinum-containing two-drug chemotherapy,and the treatment group received Jinfukang combined with Ruanhua decoction on the basis of control group treatment.All the patients were followed up regularly after 2 cycles of treatment.The main indicators were short-term efficacy,quality of life,improvement of Chinese medicine symptoms and immune function. Results In terms of tumor control rate,the objective remission rate of target lesions and disease control rate in treatment group were significantly higher than those in control group (29.55% vs 2.00%,95.46% vs 73.1%,all P<0.05).In the treatment group,the KPS score increased in 18 cases,stabilized in 25 cases and decreased in 1 case,while the KPS score improved in 1 case,stabilized in 29 cases and decreased in 15 cases in the control group.The physical condition score of the treatment group was significantly improved than that of the control group (P<0.05).In the improvement of clinical syndrome integral,the treatment group showed marked effect in 5 cases,effective in 27 cases,ineffective in 12 cases,and the control group showed marked effect in 1 case,effective in 5 cases and ineffective in 39 cases.The treatment group had better curative effect than the control group on Chinese medicine syndrome (P<0.05). Conclusion Jinfukang and Ruanhua decoction combined with chemotherapy can stabilize and narrow the focus,improve the quality of life,improve the clinical symptoms of patients with advanced lung cancer with deficiency of both Qi and Yin,and have good safety.It's an effective treatment for stage Ⅲb to Ⅳ NSCLC with Qi and Yin deficiency.