摘要Objective: To observe the curative effect of Qingre Shengji Ointment (清热生肌膏) on acute radiation dermatitis caused by radiotherapy after modified radical mastectomy. Methods: 100 patients with radiotherapy after modified radical mastectomy in our hospital from June 2019 to December 2020 were randomly divided into treatment group and control group, with 50 cases in each group. The treatment group was given Qingre Shengji Ointment (清热生肌膏) on the basis of routine nursing, and the intervention began until one week after radiotherapy, while the control group was given routine nursing. Observe and record the occurrence time of acute radiation dermatitis, the degree of acute radiation dermatitis, changes of skin erythema, pruritus, pain, changes of interleukin-6 (IL-6) and curative effect were evaluated. The degree of dermatitis was evaluated by RTOG grading standard, the erythema was evaluated by TCM symptom score, and pruritus and pain were evaluated by visual analogue scale (VAS). Blood routine, liver and kidney function, electrocardiogram and other safety indicators and adverse reactions were recorded before and after the study. Results: The time of acute radiation dermatitis was 6-11 days (median 8 days) in the treatment group and 8-14 days (median 10 days) in the control group (P<0.01). The degree and probability of acute radiation dermatitis in the treatment group were 82％ (41/50) in grade I, 16％ (8/50) in grade Ⅱ and 2％ (1/50) in grade Ⅲ. The degree and probability of acute radiation dermatitis in the control group were 54％ (27/50) in grade I, 40％ (20/50) in grade Ⅱ and 6％ (3/50) in grade Ⅲ(P<0.05). The highest TCM symptom score of skin erythema in the treatment group was lower than that in the control group (P<0.01). The results of generalized estimation equation show that, The VAS scores of pruritus and pain were (1.34±0.01) and (2.08±0.02) (Wald χ2=1198.123, P<0.01) in the treatment group and (2.08±1.74) (Wald χ2=1547.804, P<0.01) in the control group, respectively. Compared with the control group, the VAS scores of pruritus and pain were (1.14±0.01) and (2.08±1.74) (Wald χ2=1547.804, P<0.01) in the treatment group. After observation, the curative effect of the treatment group was better than that of the control group (P<0.05), and the subjective symptoms of patients were obviously improved. After treatment, the level of IL-6 in the treatment group was significantly lower than that before treatment, and was lower than that in the control group (P<0.01). Conclusion: Qingre Shengji Ointment (清热生肌膏) can prevent and treat acute radiation dermatitis to some extent, and its mechanism may be to inhibit the release of inflammatory cytokines, reduce the degree of dermatitis, improve the quality of life of patients, and its safety is good. VAS score can subjectively evaluate the changes of itching and pain, and it is easy to use, so it is worthy of clinical application