Comparative evaluation of bleomycin and setrol in the management of low flow vascular malformations in the head and neck region

Abstract

Introduction: Vascular malformations in any location usually have a devastating aesthetic effect in addition to that of being associated with pain and bleeding. Sclerotherapy has been used as an effective therapeutic modality for the management of the vascular malformations. This prospective study was intended to evaluate and compare the efficacy of bleomycin and Setrol in the management of low flow vascular malformations in the head and neck region. Materials and Methodology: The study was carried out among 60 patients within the age group ranging from 8 years – 40 years. All the patients were diagnosed with vascular malformations both clinically as well as by Doppler study. The stipulated period that was adopted for this study was between June 2019 to April 2022. After fulfilling the inclusion criteria, cases were randomly assigned into two groups of sixteen each. Group 1 was administered bleomycin 8 mg, freshly prepared in 2 ml normal saline and 2% lidocaine 2 ml. Group 2 was administered 1 ml of 3% sodium tetra-decyl sulphate and 2 ml of 2% lidocaine. Results: The effectiveness of bleomycin was found to be superior to STS, when used as Intralesional Sclerotherapy agent. Most of the vascular lesions of group 1 resolved after first dose giving a cure rate of 93.75% and only one patient required a second injection of bleomycin to obtain cure, after 3 weeks with no recurrence was observed. Group 2 patients were not cured following first intralesional injection of STS except for the small sized lesions. All the cases required 4-6, a mean of five injections to obtain cure. Ten patients out of 16 reported back with recurrence within 2 years. Six patients in group 2 came under the category of effective, giving an overall effective response rate of 37.5% and the drug was ineffective in of 62.5% cases. Conclusion: Sclerotherapy with direct intralesional injection of bleomycin was found to be superior to STS and found that there was no recurrence rate in bleomycin group when compared to STS group. However, 3% Setrol solution is relatively simple, safe and effective modality for managing head and neck vascular malformations that can be done as an in-office procedure. Smaller lesions have a more favourable response.