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Objective:The present study aimed to investigate the efficacy of Shenfu injection plus vinorelbine on the promotion of the quality of life (QOL) in elderly non-small cell lung cancer (NSCLC) patients.Methods:A randomized single blind trial method was used.Forty-six patients with stage ⅢB-Ⅳ of NSCLC were randomly divided into experimental group and control group.In the experimental group,the patients were treated with 50 mL Shenfu injection from day 1 to 14,plus vinorelbine (NVB) 25 mg/m2 on day 1 and 8.In the control group,the patients were only treated with NVB 25 mg/m2 on day 1 and 8.After two cycle's of treatment,QOL,efficacy and toxicity were observed.Results:The QOL was enhanced in both experimental group and control group.However,the difference of KPS after treatment in the experimental group was markedly higher than in the control group (14±10 vs.8±10,t=2.116,P=0.04),improvement rate of QOL was better than in the control group (76.2% vs.45.0%,X2=4.188,P=0.041 ),treatment related toxicity in the experimental group was also markedly lower than in the control group (X2=3.866,P=0.049),but the difference of efficacy between the two groups was not significant (14.3% vs.15.0%,X2=0.161,P=0.688).Conclusion:Shenfu injection plus vinorelbine can enhance QOL in elderly NSCLC patients.