A clinical study of pingyangmycin sclerotherapy for venous malformation: an evaluation of 281 consecutive patients.

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: In China, lidocaine together with 2 mg/mL of pingyangmycin (PYM, also known as bleomycin A5) is recommended for the treatment of venous malformations (VMs). The purpose of this study was to investigate whether lidocaine has a synergistic effect with PYM in improving the therapeutic outcomes of patients with VMs. Additionally, this study aimed to evaluate the outcomes of sclerotherapy for VMs using an intralesional injection of a low concentration of PYM (0·5 mg/mL). METHODS: A total of 281 patients with VMs were treated with 0·5 or 2 mg/mL of PYM with or without lidocaine and dexamethasone (DEX). All of the patients received a direct intralesional injection at a rate of 1 mL/min, and the volume of the solution varied from 1·5 to 6·0 mL per injection. RESULTS AND DISCUSSION: No significant differences were observed in the clinical outcomes between the PYM and PYM + lidocaine treatment groups (P > 0·05). The clinical outcomes were similar between the groups that were treated with 0·5 and 2 mg/mL of PYM, but the swelling and pain in the patients who were treated with 0·5 mg/mL of PYM were less severe compared with the patients who were treated with 2 mg/mL of PYM. A total of 29 patients with VM lesions on the glans penis were treated with 0·5 mg/mL of PYM + 0·5% lidocaine. Of these patients, 26 were cured, whereas three experienced a marked improvement. WHAT IS NEW AND CONCLUSION: Lidocaine does not have a synergistic effect with PYM in improving the therapeutic outcomes of patients with VMs. Sclerotherapy with a low concentration of PYM (0·5 mg/mL) combined with lidocaine and DEX is a safe and effective therapy for small superficial VMs of critical organs, such as the lips and the glans penis.