| OBJECTIVE: To observe the clinical efficacy and safety of nourishing yin and clearing away heat,detoxification and promoting collaterals of traditional Chinese medicine method combined with gefitinib in the treatment of EGFR mutations in nonsmall cell lung cancer.Methods: 60 patients who met the inclusion criteria were randomly divided into experimental group and control group,each with 30 cases.The control group was given gefitinib 250 mg po qd.On the basis of the same treatment as the control group,the experimental group was treated with traditional Chinese medicine of nourishing yin and clearing away heat,detoxification and promoting collaterals.After 8 weeks of treatment,changes in the TCM syndrome scores,objective tumor efficacy indicators,quality of life KPS scores,serum CEA,safety indicators,and adverse reactions were evaluated and compared between the two groups.Results: 1.Before treatment,there was no significant difference between the two groups(P > 0.05)in the baseline comparison of basic data and observation indexes,such as gender,age,pathological type,TNM stage and EGFR mutation type.Two groups were comparable.2.TCM Syndrome Score: Compared with the group before and after treatment,the scores after treatment in both groups were lower than before treatment,and the difference was statistically significant(both P<0.05);after treatment,the experimental group score is lower than the control group,with statistical difference(P<0.05).Comparing the efficacy of the two groups,the effective rate of TCM syndromes in the experimental group after treatment was significantly higher than that in the observation group,and the difference was statistically significant(P<0.05).3.Objective curative effect analysis of tumors: Comparison between groups after treatment,analysis of tumor efficacy in the two groups showed that the DCR of the experimental group was 90% and the ORR was 56.7%,which were higher than the DCR of the control group 86.7% and ORR 46.7%,respectively.But the difference between the two groups was not statistically significant(P> 0.05).4.Serum CEA: Comparison between the groups before and after treatment.The serum CEA values of the two groups after treatment were less than those before treatment,and the differences were statistically significant(both P <0.05).Comparison between the two groups after treatment,the serum CEA value of the experimental group was significantly lower than that of the control group(P < 0.05).5.Quality of life KPS score: The comparison between the groups before and after treatment,the KPS scores of the two groups after treatment are higher than before treatment,and the differences are statistically significant(both P <0.05);Comparing the two groups after treatment,the KPS score of the experimental group was higher than the control group,and the difference was statistically significant(P <0.05).6.Safety and adverse reaction results: Fluctuations in safety indicators such as blood routine,liver and kidney function,coagulation function,and electrocardiogram before and after treatment in the two groups were within the normal range or no significant abnormalities were observed.The incidence of adverse reactions such as diarrhea and skin reactions were lower than those in the control group,and the differences were statistically significant(both P <0.05).There was no significant difference in the incidence of oral ulcer between the two groups.Conclusion: Compared with gefitinib alone,nourishing yin and clearing heat,detoxification and promoting collaterals of traditional Chinese medicine method combined with gefitinib in the treatment of Syndrome of yin deficiency and heat toxin,phlegm and blood stasis blocking collaterals type NSCLC EGFR mutants are more effective in improving TCM syndromes,improving quality of life,lowering serum CEA,and reducing side effects,and has good safety,but there is no significant advantage in reducing tumor size. |
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