Objective To observe the clinical curative effects and safety of Wuwei Xiaodu Yin（ 五味消毒饮） in treating rash associated with epidermal growth factor receptor tyrosine kinase inhibitors（ EGFR-TKIs） in patients with lung cancer. Methods Sixty patients with lung cancer appearing rash after taking EGFR-TKIs orally were randomly divided into a treatment group and a control group

with 30 cases in each. Two groups were both given routine treatment. Based on it

the control group received external application of urea cream on affected parts 3 or 4 times per day

and the treatment group was given Wuwei Xiaodu Yin orally combined with external washing one dose per day.The treatment courses for two groups were both 2 weeks. Chinese syndrome scores were evaluated and levels of high sensitivity C-reactive protein and interleukin 6（ IL-6） in peripheral blood were examined before and after treatment.Quality of life grading was conducted before and 30 days after treatment. Severity of rash grading assessment was performed before and after treatment

and the safety and curative effects of the treatment were evaluated. Results The total rates of clinical and syndrome curative effects in the treatment group were 73. 3% and 80. 0% respectively

while that of the control group were 40. 0% and 50. 0% respectively. The treatment group was remarkably higher than that of the control group（ P > 0. 05）. Chinese medicine syndrome scores in two groups all decreased after treatment（ P <0. 05）. Chinese medicine syndrome scores in the treatment group after treatment was remarkably lower than that in the control group（ P < 0. 05）. Quality of life scores of patients in the treatment group 30 days after treatment were remarkably lower than that in the control group（ P < 0. 05）. Severity of rash grading assessment and levels of high sensitivity C-reactive protein and IL-6 in the treatment group after treatment all remarkably decreased（ P < 0. 05）.Severity of rash grading assessment and levels of high sensitivity C-reactive protein and IL-6 in the treatment group after treatment were all lower than that in the control group（ P < 0. 05）. There were no statistically significant differences between two groups when comparing blood routine

liver and kidney function and electrocardiogram of two groups before and 30 days after treatment（ P > 0. 05）. Conclusion The clinical curative effects of Wuwei Xiaodu Yin（ 五味消毒饮） in treating rash associated with EGFR-TKIs in patients with lung cancer is clear. And its safety is good.