Objective To observe the therapeutic effect of Shenyi Capsule（capsule of ginsenoside） combined with gefitinib on advanced non-small cell lung cancer （NSCLC）.Methods Totally 100 NSCLC patients who failed in chemotherapy in the Ⅲb-Ⅳ stage were randomized into treatment group and control group with 50 cases in each.Gefitinib 250mg

once daily was given to the control group and Shenyi Capsule 20mg

twice daiyly was added to the treatment group.Sixty days later

the short-term effect

quality of life （QOL） and adverse reactions were observed.Progression-free survival（PFS） was observed according to 2 years of follow-up.Results The effective rate including complete remission（CR） and partial remission（PR） of the treatment group and the control group was 26.53% and 22.92% respectively.The control rate including CR

PR and stable disease（SD） of the treatment group and the control group was 59.18% and 50% respectively.There was no significant difference between groups（P>0.05）.The median PFS was 132.00±6.22 and 112.00±9.39 days in the treatment group and the control group respectively

with significant difference（P=0.037）.The improvement rate of QOL was 91.8 4% and 66.67% in the treatment group and the control group respective ly

with significant difference（P<0.05）.The incidence of diarrhea in the treatment group was significantly lower than that in the control group（P<0.01）. The incidence of grade Ⅲ-Ⅳ rash

nausea

vomiting and abnormal liver function in the treatment group was lower as compared with the control group

but the differ ence between was not statistically significant.Conclusion The therapeutic effect of Shenyi Capsule combined with gefinitib for advanced NSCLC is superior to that of single-agent treatment with gefinitib

especially prolonging the PFS of p atients benefited from gefinitib.