Objective  To investigate the efficacy of Chinese medicine Qingfei Mixture combined with chemotherapy on middle and advanced non-small cell lung cancer (NSCLC) patients.

Methods  From November 2011 to February 2014, 98 cases with middle and advanced NSCLC were randomly divided into two groups: chemotherapy alone group (the control group, 34 cases) and Qingfei Mixture combined with chemotherapy group (the experimental group, 64 cases). The differences of clinical curative effect, overall survival(OS), toxicities and quality of life(QOL) between the two groups were compared.

Results  The response rate (RR) was 11.8% and disease control rate(DCR) was 76.5% in the experimental group. In the control group, the RR was 24.0% and DCR was 76.0%. There was no significant difference in RR or DCR between two groups(all P>0.05). The follow-up rate in the investigation was 89.8% with six cases lost to follow up. There was no significant difference in 1- or 2- year survival rate between the two groups(P=0.569; P=0.802). Cox multivariate analysis showed that chemotherapy cycle was an independent risk factor for the prognosis of patients with NSCLC (HR=0.358, 95%CI: 0.158-0.810, P=0.014). According to the evaluation standard of TCM therapeutic effect of solid tumor, the traditional Chinese medicine(TCM) efficacy score in the control group after treatment was (50.89±6.47) and that in the experimental group was (54.12±6.77), without significant difference between the two groups(P=0.742). During the treatment, there was no significant difference in white blood cells, platelets, hemoglobin, transaminase or creatinine between the two groups (all P>0.05).

Conclusion  Compared with chemotherapy alone, there is no significant difference in recent response, 1- and 2-year survival rates, clinical symptoms improvement or toxicities in Qingfei Mixture combined with chemotherapy on middle and advanced NSCLC patients.