ABSTRACT
OBJECTIVE： To systematically evaluate the effects of Shenqi fuzheng injection combined with conventional chemotherapy on the immune function of patients with advanced non-small cell lung cancer （NSCLC）， and provide evidence-based reference for clinical medication. METHODS： Retrieved from Cochrane Library， PubMed， Medline， Embase， CNKI， Wanfang database， VIP and CBM， Shenqi fuzheng injection combined with conventional chemotherapy （trial group） versus conventional therapy （control group） for advanced NSCLC were collected. After literature screening， data extraction and quality evaluation with Cochrane system evaluator manual 5.1.0 risk evaluation tool， Meta-analysis was performed by using Rev Man 5.3 statistical software. RESULTS： A total of 16 literatures were included， involving 1 324 cases. Results of Meta-analysis showed that there were no statistical significance in the difference of objective remission rate （ORR） [RR＝1.14， 95％CI（0.91，1.43）， P＝0.25] and the level of CD8+ [MD＝－1.26，95％CI（－4.10， 1.59），P＝0.39] between 2 groups. The levels of CD3+ [MD＝17.48， 95％CI（13.40， 21.56）， P＜0.000 01 ]， CD4+[MD＝12.26， 95％CI（8.39 16.13）， P＜0.000 01]， CD4+/CD8+ [MD＝0.33，95％CI（0.27， 0.39），P＜0.000 01] and the percentage of NK cells [MD＝9.33， 95％CI（5.72， 12.94）， P＜0.000 01] in trial group were significantly higher than control group. Results of subgroup analysis for medication duration of Shenqi fuzheng injection showed that after 1-14 d treatment of Shenqi fuzheng injection， the levels of CD3+ [MD＝17.11， 95％CI（12.37 ，23.17），P＜0.000 01]， CD4+[MD＝13.28，95％CI（8.33， 18.23），P＜0.000 01]， CD4+/CD8+[MD＝0.36，95％CI（0.28，0.43），P＜0.000 01] and the percentage of NK cells [MD＝12.06，95％CI（7.52，16.61），P＜0.000 1] in trial group were significantly higher than control group. After 21 d treatment of Shenqi fuzheng injection， the levels of CD3+[MD＝14.88， 95％CI（7.51，22.26），P＜0.000 01]， CD4+[MD＝10.56，95％CI（5.57，15.56），P＜0.000 01]， CD8+[MD＝3.02， 95％CI（1.80， 4.23），P＜0.000 01]， CD4+/CD8+[MD＝0.29，95％CI（0.23， 0.35），P＜0.000 01] and the percentage of NK cells [MD＝5.58，95％CI（2.49， 8.67），P＝0.000 4] in trial group were significantly higher than control group. There was no statistical significance in the level of CD8+ between 2 groups after 7-14 d treatment of Shenqi fuzheng injection [MD＝－4.26，95％CI（－12.60， 4.09），P＝0.32]. The incidence of leukopenia， nausea and vomiting， and renal dysfunction in trial group were significantly lower than control group. There was no statistical significance in the incidence of hemoglobin decreased and thrombocytopenia between 2 groups. The results of publication bias showed that there was a greater possibility of publication bias in this study. CONCLUSIONS： Shenqi fuzheng injection combined with conventional chemotherapy may improve the immune function of patients with advanced NSCLC and improve the safety after chemotherapy. But more large-scale， milltiple-center and high-quality RCT are needed to validate this conclusion.