Clinical Study On Modified Tiaozhong Yiqi Decoction In The Treatment Of EGFR-TKI Related Diarrhea In Non-small Cell Lung Cancer

Objective: To study the influence of modified Tiaozhong Yiqi Decoction(cure group)on patients with EGFR-TKI related diarrhea and spleen deficiency syndrome of non-small cell lung cancer,and to assess the clinical efficacy of modified Tiaozhong Yiqi Decoction by observing the number of defecation,diarrhea grade,TCM syndrome(spleen deficiency type)score,KPS score change,and diarrhea recurrence before and after treatment.Methods: A total of 72 patients were included.The included cases were randomly divided into the cure group and the matched group,with 36 cases each.The cure group was treated with modified Tiaozhong Yiqi Decoction,and the matched group was treated with Shenling Baizhu Granule.Two courses of treatment(14 days)were observed.Observe the defecation frequency of patients before and after treatment,the classification of diarrhea before and after treatment,the change of TCM syndrome(spleen qi deficiency type)score,Change of KPS score.The patients were followed up on the 7th day after treatment,and record the recurrence of diarrhea to assess the efficacy.Results: A total of the 72 patients included in this study,1 case fell off in the cure group and 1 case fell off in the matched group,and 70 cases completed this study,35 cases in each group.(1)The number of defecation: After 7 days of treatment,the number of defecation in both groups decreased compared with that before treatment,and the number of defecation in the cure group was lower than that in the matched group(P<0.05).After 14 days of treatment,the defecation frequency of the two groups was observably lower than that of the matched group after 7 days of treatment(P<0.01).(2)Diarrhea grade: After 7 days of treatment,the effective rate of diarrhea grade in the cure group was 80.0%,while that in the matched group was 74.3% that was better than that in the matched group(P<0.05);After 14 days of treatment,the effective rates of diarrhea grade in the cure group and the matched group were 91.4% and 77.1%,respectively,and the cure group was better than the matched group(P < 0.01).(3)TCM symptom score: After treatment,the total points of TCM symptoms in the cure group was observably improved than that in the matched group(P<0.01).The total effective rates of the cure group and the matched group were 91.43% and 68.57%,respectively.The cure group was better than the matched group(P<0.01);The scores of each single symptom in the cure group after treatment were lower than those pretherapy(P<0.05);Compared with before treatment,the single symptom scores of the cure group were decreased after treatment(P<0.05),and the symptom scores of semiotic of diarrhea,mental fatigue,lazy speech,fatigue,lack of appetite,and abdominal distension after eating decreased(P < 0.05),and the yellowing complexion was not significantly improved(P > 0.05).There was no significant difference in abdominal distension between the two groups(P > 0.05).After treatment,the improvement of symptoms such as diarrhea,mental fatigue,languor,fatigue,lack of appetite and sallow complexion in the cure group was better than that in the matched group(P < 0.05).(4)KPS score: The effect of the cure group was better than that of the matched group(P<0.05).(5)Diarrhea recurrence: The 7th day after treatment,the two groups of patients were followed up by telephone.A total of 61 effective cases were collected,including 33 in the cure group and 28 in the matched group.The recurrence rate of diarrhea was 12.1% in the treatment group and 35.7% in the control group.The recurrence rate in the cure group was observably lower than that in the matched group(P<0.05).(6)Safety evaluation: both the cure group and the matched group are safe,no adverse reactions.Conclusion: Compared with Shenling Baizhu Granule,the modified Tiaozhong Yiqi Decoction has obvious advantages in reducing the number of defecation,reducing the grade of diarrhea,improving TCM syndromes,improving the physical condition and quality of life of patients with spleen qi deficiency type non-small cell lung cancer EGFR-TKI related diarrhea,and controlling diarrhea recurrence.