Non-inferiority Controlled Study Of Golden Powder Combined With Vitamin E Topical Treatment Of Radiation Dermatitis And Biafine

Objective:The clinical efficacy and safety of Golden powder combined with Vitamin E in the treatment of radiation dermatitis were investigated.Methods:50 patients with radiation dermatitis were randomly divided into Golden powder combined with Vitamin E group and Biafine group with 25 cases in each group. After 4 weeks of treatment, the efficacy of drugs, the relationship between cure rate and extent of lesions, the relationship between healing time and degree of skin lesions were observed. And the KPS scores and the rate of adverse reactions were recorded.Results:The cure rate for Golden powder combined with Vitamin E on radiation dermatitis was 80.0% and the effective rate was 92.0%; and they were 84.0% and 100% for Biafine group, respectively. The effective rate for Biafine group was little higher than the Golden powder combined with Vitamin E group, but which did not reach the level of statistical significant difference (P>0.05). The cure rate for Golden powder combined with Vitamin E on class I, II, III and IV skin damage was 100%,80%,83.3% and 50.0%; and the cure rate for Biafine was 100.0%,90.9%,75.0% and 100.0%. The cure rates for the two groups were approximately the same and there were no significant differences (P>0.05). The average healing time of class I, II, III and IV of skin damage for Golden powder combined with Vitamin E group was 8.0,11.35,15.66 and 23.0 days, respectively; and they were 7.0,10.68, 17.03 and 21.0 days for Biafine group. There were no significant differences between the two groups (P>0.05). The KPS score was increased 18.62% at post-treatment than pre-treatment for the Golden powder combined with Vitamin E group (P<0.05); and which was 17.38% for the Biafine patients (P<0.05). There were no significant differences in KPS scores between the two groups at post-treatment or pre-treatment (P>0.05). One patient in the Golden powder combined with Vitamin E group had allergic reactions during the treatment; and no adverse reactions were found in the Biafine group.Conclusion:Golden powder combined with Vitamin E was effective in treating radiation dermatitis, which could effectively reduce the symptoms of radiation dermatitis and inflammatory exudates, promote wound healing and shorten healing time. Its efficacy is not inferior to Biafine.