| Objective: To verify the efficacy and safety of modified Shaoyao Decoction in treating diarrhea(intestinal damp-heat type)caused by oral administration of EGFR-TKI drugs.Methods:The patients involved in this study were collected from Jilin Cancer Hospital from January 2022 to December 2022,and 80 patients with definite pathological diagnosis of lung cancer and diarrhea after EGFR-TKI drugs were selected The eligible patients were randomly divided into two groups with 40 cases in each group The treatment group was treated with loperamide capsule combined with Shaoyao Decoction for 14 days The control group was treated with loperamide capsules for 14 days Record the diarrhea grade,TCM syndrome score,etc.on the first day of admission,the seventh day of treatment and the fourteenth day of treatment,and record the safety index on the first day of admission and the fourteenth day of treatment.After the treatment,make statistics on the results.Results:1.Baseline data: Before treatment,there was no difference in age,gender targeting and diarrhea grade between the two groups.The baseline of the two groups was comparable In the middle of the study,there were 78 cases,39 cases in each group,who lost 1 case in the experimental group and 1 case in the control group.2.Curative effect:(1)Comparison of therapeutic effects of diarrhea grade: After 7 days of treatment,the effective rate of patients in the experimental group was 79.48%,and that of patients in the control group was 66.66%.There was no statistical significance between the two groups(P > 0.05);After 14 days of treatment,the effective rates of the two groups were 89.74% and 74.35%,respectively.At this time,the curative effect of the experimental group was better than that of the control group(P < 0.05).(2)Comparison of TCM syndromes:In-group comparison: After treatment,the total scores of TCM syndromes in the experimental group and the control group decreased significantly compared with those before 3 treatments(P <0.01)After treatment,the scores of each syndrome in the experimental group and the control group were higher than those before treatment(P < 0.05).Comparison between groups: After 7 days and 14 days of treatment,the total scores of TCM syndromes in the experimental group were lower than those in the control group,and there was significant difference between the two groups(P <0.01)After 7 days of treatment,the symptoms of purulent blood,bowel sounds,thirst and no desire to drink in the experimental group were better than those in the control group(P < 0.05).There was no significant difference in other symptoms(P > 0.05).After 14 days of treatment,the scores of diarrhea,smelly,burning,purulent,bloody stool,bowel sounds,thirst and no desire to drink in the experimental group were better than those in the control group(P < 0.05).(3)Comparison of KPS scores: After 7 days and 14 days,the KPS scores of the two groups were significantly higher than those before this group(P < 0.05)After 7 days of treatment,there was no significant difference between the two groups(P > 0.05).After 14 days of treatment,the experimental group was superior to the control group(P < 0.05).3.Comparison of adverse reactions: 1 case of flatulence and 1 case of nausea occurred in the experimental group during the treatment,and the total incidence rate was 0.05%;In the control group,1 case had dizziness and headache,3 cases had flatulence and 2 cases had nausea during treatment,and the total incidence rate was 0.15% The incidence of adverse reactions in experimental group was lower than that in control group.Conclusion: The combination of Loperamide capsules and Loperamide capsules alone can improve the diarrhea of EGFR-TKI patients,but the overall effect of the combination is better than that of Loperamide capsules alone.It has more advantages in improving the TCM syndromes such as diarrhea,filth,burning pain,pus,blood,stool,bowel sounds,etc.and can improve the KPS score of patients and improve the incidence of adverse reactions of patients.Acceptable safety. |
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