Abstract： Objective： To analyze the clinical effect of Shashen Maidong tang combined with Kanglaite injection for patients undergoing chemotherapy who had non-small cell lung adenocarcinoma at middle-advanced stage by retrospective analysis. Methods： Among a total of 72 cases of enrolled patients with non- small cell lung adenocarcinoma at middleadvanced stage who were admitted and treated from June 2012 to June 2014，retrospective analysis was conducted on their clinical data. All patients were divided into the control group and the study group according to therapeutic schemes，36 cases in each group. The control group was given routine chemotherapy， and the study group was additionally given the oral administration of Shashen Maidong tang and intravenous drip of Kanglaite injection based on the chemotherapy regimen of the control group. After treatment，the clinical effect was counted in the two groups. Before and after treatment，the levels of cytokeratin 19 fragment antigen 21-1(Cyfra21-1) and carcinoembryonic antigen(CEA) in serum ， toxic side effects， and indexes of immune function including CD3+，CD4+，CD8+，and CD4+/CD8+ were counted. After treatment，all patients were followed up from one to three years； the survival in the two groups was counted. Results： The total effective rate was 75.00% in the study group， higher than that of 50.00% in the control group ， the difference being significant(P＜0.05). After treatment，the levels of Cyfra21- 1 and CEA in serum in the two groups were decreased when compared with those before treatment，and the two levels in the study group were lower than those in the control group，the difference being significant(P＜0.05). No toxic side effects of Ⅳ degree occurred in the two groups； in the study group， the diarrhea rate (16.67%)，the rate of nausea and vomiting(19.44%)，the myelosuppression rate(22.22%)，and the leukopenia rate(19.44%) were all lower than those in the control group(P＜0.05). After treatment，the indexes of CD3+，CD4+，and CD4+/CD8+ in the study group were higher than those in the control group，and CD8+ was lower(P＜0.05). In the study group，the median survival time was 23.1 months，and the progression free survival was 20.6 months. In the control group，the median survival time was 18.0 months，and the progression free survival was 15.7 months. The one- year survival rate was 86.11% in the study group，higher than that of 61.11% in the control group，the difference being significant(P＜0.05). When compared the two- year and the three- year survival rates respectively，there was no significant difference being found between the two groups(P＞0.05). Conclusion： In the treatment of non- small cell lung adenocarcinoma at middle- advanced stage， the combined therapy of Shashen Maidong tang and Kanglaite injection based on chemotherapy can effectively reduce the levels of Cyfra21- 1 and CEA in serum and the incidence of toxic side effects， improve immune function of body and curative effect，as well as increase short-term survival rate.