The Efficacy of Combination Therapy Involving Excision Followed by Intralesional 5-Fluorouracil and Betamethasone, and Radiotherapy in the Treatment of Keloids: A Randomized Controlled Trial

Abstract

Background Combined therapy for keloids is currently recommended. Surgery is one of the main options, but the measures to prevent recurrence after excision are still being explored. Objective The randomized controlled study aimed at evaluating the efficacy of excision followed by intralesional low concentrations of 5-fluorouracil (5-FU)(12.5 mg/mL) and betamethasone. Methods Sixty patients were randomly assigned to three groups. Patients in group A had excision followed by 5-FU and betamethasone intralesional injections, group B had 5-FU and betamethasone intralesional injections, and group C had excision followed by radiotherapy. Efficacy parameters were assessed from 8 to 12 months, including improvement on the Vancouver Scar Scale (VSS) and the Patient and Observer Scar Scale (POSAS), as well as side effects and recurrence. Trial registration number: ChiCTR2100046025. Results After 4 months’ treatment, the improvement of the VSS and POSAS scores in group A was not different from that in group C ( P > 0.05) but was superior to that in group B ( P < 0.05); the pain and pruritus of the three groups were relieved more than 50%. After 8 to 12 months’ follow-up, there was no statistical difference in the incidence of side effects and recurrence among the groups ( P > 0.05). Conclusion Excision followed by intralesional low concentrations of 5-FU (12.5mg/mL) with betamethasone is a safe and sustainable treatment for keloid, with no significant difference from excision followed by radiotherapy.

Comparison of surgical excision followed by adjuvant radiotherapy and laser combined with steroids for the treatment of keloids: A systematic review and meta‐analysis

“…After thoroughly reading the full text, 56 articles that were inconsistent with the research results were excluded, and ultimately 26 articles were included. 3 , 13 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 The basic characteristics of the included studies are detailed in Table 1 . To obtain the latest pooled results, articles published since 1 January 2010 were merely included.…”

“…The subsequent review of titles and abstracts led to the exclusion of 4969 articles. After thoroughly reading the full text, 56 articles that were inconsistent with the research results were excluded, and ultimately 26 articles were included 3,13,19–42 . The basic characteristics of the included studies are detailed in Table 1.…”

Liposomes Loaded with 5-Fluorouracil Can Improve the Efficacy in Pathological Scars

“…8 This option is not only less invasive but also more cost-effective and accessible compared to surgical excision and laser ablation. 9 , 10 Common injectable medications include Corticosteroids, Fluorouracil (5-Fu), and Bleomycin. Although corticosteroids have been effective for most patients, they have also been associated with troublesome side effects, including hormonophobia, hypopigmentation, subcutaneous fat atrophy, telangiectasias, rebound effects and ineffectiveness.…”