| Objective:To observe the therapeutic effect of Jiawei Fumai Decoction combined with Gefitinib in the treatment of patients with EGFR mutation advanced lung adenocarcinoma(qi-yin deficiency type),And to evaluate its safety in the treatment of patients with advanced lung adenocarcinoma of qi-yin deficiency.Methods:Sixty patients who met the inclusion criteria were randomly divided into Jiawei Fumai Decoction combined with Gefitinib group and Gefitinib group.All drugs are taken for 2 months.the changes of tumor indexes,TCM syndrome scores,KPS scores,CEA,IL-2,IL-6 and other side effects were observed and compared between the two groups of patients.Results:1 In the evaluation of the short-term curative effect of solid tumor:The statistical results indicates that the ORR and DCR of the treatment group are higher than those of the control group,however,after the rank sum test of the disease control situation,there was no statistical difference between the two groups;2 Changes in CEA:There was no significant difference in CEA between the two groups before treatment(P>0.05).CEA of the two groups after treatment was lower than before,and there was significant statistical significance in the comparison within the group(P<0.01).CEA of the treatment group was lower than that of the control group,and there was also statistical significance after t-test(P<0.05);3 The curative effect of TCM symptom score:The effective rate was 90.0%in the treatment group and 76.67%in the control group.the difference between the two groups is statistically significant.(P<0.05);4 Efficacy of KPS:The curative effect of the treatment group is significantly better than the control group,the difference between the two groups is statistically significant.(P<0.05);5 Cytokine IL-2 level:There was no significant difference in IL-2 level between the two groups before treatment by t test(▲P>0.05).After treatment,the average level of IL-2 in the treatment group was significantly higher than that in the control group,and there was a statistically significant difference between the two(P<0.01).The IL-2 levels of the two groups before and after treatment were visible,and the IL-2 levels of the two groups after treatment All of them were significantly increased and all had statistical significance(△P<0.05,▽<0.05);6 Cytokines IL-6 levels:There was no significant difference in IL-6 levels between two groups of patients before treatment by t test(▲P>0.05).After treatment,the IL-6 levels of the two groups of patients decreased,and there was statistical significance between the groups and within the groups(▼P<0.01,△P<0.05,▽P<0.05);7 Security:During the observation period,there were no obvious adverse reactions such as bone marrow suppression,liver and kidney damage.There were no other adverse events;8 Side effects:During the observation period,The toxic and side effects of the two groups were mainly rash and diarrhea.According to statistical results,the incidence of rash and diarrhea in the treatment group was lower than that in the control group,There was statistical difference between the two groups(P<0.05).Conclusion:The combination of gefitinib and Jiawei Fumai Decoction in the treatment of advanced lung adenocarcinoma(qi-yin deficiency and EGFR mutation)can better relieve the uncomfortable symptoms,reduce the incidence of rash and diarrhea as well as it has good security. |