To observe the clinical efficacy of traditional Chinese medicine ulcer oil combined with the western medicine compound vitamin B₁₂ solution in the prevention and treatment of radiation-induced skin injury.

Totally 110 patients with head, neck and chest malignant tumors requiring radiotherapy who were admitted to the Department of Integrated Traditional Chinese and Western Medicine Oncology and other departments, China-Japan Friendship Hospital from September 2016 to June 2021 were enrolled and divided into observation group and control group randomly under the condition of single-blind, with 55 patients in each group. The observation group was treated with ulcer oil and compound vitamin B₁₂ solution twice a day; the control group was only given compound vitamin B₁₂ solution twice a day until one week after the end of radiotherapy. On the 14th, 21st and 28th days, the time of skin injury occurrence, skin ulcer, Radiation Therapy Oncology Group (RTOG) grading, numerical rating scales, and drug safety were recorded. Clinical follow-up was conducted at 1 month and 6 months after the radiotherapy. Data were compared by χ² test, t test and rank-sum test.

(1)In the observation group, the occurrence time of radiation-induced skin injury was 16.0(13.0, 17.0)days, and the duration was 33.0(28.0, 34.0)days; in the control group, the occurrence time was 10.0(8.0, 12.0)days and the duration was 45.0(34.0, 48.0)days, which were significantly different between the two groups (Z=1.473, 5.361, P<0.05). (2)The incidence of radiation dermatitis in the observation group was 70.91%, significantly lower than 85.45% of the control group (χ²=8.338, P<0.05); the incidence of skin ulcer was 30.91% in the observation group and 50.91% in the control group with significant difference between the two groups (χ²=9.575, P<0.05). (3)No significant difference was found in total number of RTOG grading between the two groups at the 14th day of radiotherapy and the 6-month follow-up(χ²=0.015, 0.340, P>0.05). The total number of RTOG grading of the observation group was significantly less than that of the control group at the 21st, 28th days of radiotherapy and the 1-month follow-up (χ²=4.677, 5.006, 3.757, P<0.05). (4)There was no significant difference in NRS score between the two groups during radiotherapy(Z=0.903, 0.871, 0.913, P>0.05) and 6-month follow-up (Z=1.250, P>0.05). The NRS score was significantly lower in the observation group than in the control group at 1-month follow-up [0.5(0.3, 1.0) vs. 4.0(2.5, 6.0), Z=2.953, P<0.05]. (5)No adverse reaction was found in the observation group during the application of ulcer oil.

Ulcer oil combined with compound vitamin B₁₂ solution for external use can delay the occurrence of radiation-induced skin injury and shorten its duration, reduce the incidence of radiation dermatitis and skin ulcers, alleviate pain symptoms, and thereby can avoid delay in radiotherapy treatment.