| Objective: The clinical efficacy of modified xiaofeng powder on EGFR-TKIs related adverse skin reactions was evaluated by comparing TCM syndromes score(wind-heat type),the grade of adverse skin reactions and DLQI score before and after treatment in the two groups.Methods: A total of 48 cases were included,and 24 cases were divided into two groups by random number table method.Control group: Hydrocortisone cream was applied topically on the basis of maintaining the original targeted therapy.Treatment group: on the basis of the control group,the internal administration of Chinese medicine modified xiaofeng powder.After 1 course of treatment(14 days),TCM syndrome score(wind-heat type),the grade of adverse skin reactions,DLQI score and safety indexes of patients in the two groups were observed for evaluation.Results: Among the 48 cases included,3 cases in the treatment group and 2 cases in the control group were lost to follow-up due to the epidemic,and 1 case was lost due to the need for chemotherapy after inclusion.Finally,a total of 42 patients completed the study.(1)TCM syndromes: the total effective rate of the treatment group(81%)was significantly better than the control group(52%)(P<0.05).From the total score of TCM syndromes,the treatment group was significantly lower than the control group after treatment(P<0.05).From the perspective of individual symptoms,the treatment group was better than the control group in the improvement of symptoms such as skin rash location,skin rash degree,pruritus,dry skin,thirst,constipation,scanty dark urine(P<0.05),but there was no significant difference in the improvement of skin rash color and skin pain between the two groups(P<0.05).(2)The grade of adverse skin reactions: after treatment,the grade of skin rash and pruritus in both treatment group and control group were significantly reduced(P<0.05),but the reduction rate in treatment group was higher than that in control group(P<0.05).(3)DLQI score: After treatment,the quality of life of both the treatment group and the control group could be significantly improved(P<0.05),but the treatment group was better than the control group(P<0.05).(4)Safety indicators: During the observation period,there was no significant abnormality in blood routine,liver and kidney function,and ECG of patients in the two groups,and there was no obvious adverse reaction of test drugs.The test process was safe and reliable.Conclusions: Modified xiaofeng powder can significantly reduce EGFR-TKIs related adverse skin reactions in patients,significantly improve the TCM symptoms such as thirst,constipation,scanty dark urine in patients with wind-heat type,and effectively improve the quality of life of patients. |