Abstract:Objective To study the efficacy of Shengmai capsule combined with a representative epidermal growth factor receptor (EGFR) - tyrosine kinase inhibitor (TKI) in the treatment of advanced non-small cell lung cancer (NSCLC). Methods The 90 patients with advanced NSCLC admitted to the Affiliated Hospital of Hangzhou Normal University from January 2018 to September 2019 were randomly divided into the combination group (30 cases), the Shengmai capsule group (30 cases) and the EGFR-TKI group (30 cases). All the patients in the three groups were treated with routine therapy and optimal nutritional support. In the EGFR-TKI group and the Shengmai capsule group, the first-generation EGFR-TKI Kemena or Shengmai capsule was taken orally, respectively. In the combination group, EGFR-TKI and Shengmai capsule were both administrated as above. All the three groups were treated with 3 months. The therapeutic efficacy, KPS score, immune function and adverse reactions of the three groups were compared before and after treatment. Results Objective response rate (ORR) of the combination group was higher than that of Shengmai capsule group and EGFR-TKI group (P < 0.05). There was no significant difference in disease control rate (DCR) among the three groups (P > 0.05). The differences in KPS scores of the combination group before and after the treatment were smaller than those of Shengmai capsule group and EGFR-TKI group (P < 0.05). On the contrary, the differences in CD3+, CD4+ and CD4+/CD8+ before and after the treatment were greater in the combination group than those in Shengmai capsule group and EGFR-TKI group (P < 0.05). There was no significant difference in adverse reactions among the three groups (P > 0.05). Conclusions Shengmai capsule combined with the first-generation EGFR-TKI Kemena shows great therapeutic efficacy in advanced NSCLC, which can improve the quality of life and immune function of patients.