A Proof-of-Concept Assessment of the Safety and Efficacy of Intralesional Diclofenac in the Treatment of Cutaneous Neurofibromas

• 作者: Aguinaldo Bonalumi Filho Allan Bernacchi Allan E. Rubenstein David Azulay Karin Soares Gon?alves Cunha Lisa Oliveira Luiz Guilherme Darrigo Jr. Marcia Gon?alves Ribeiro Mauro Geller
• 来源期刊: 临床医学国际期刊(英文)
• 学科: 医学
• 关键词: NEUROFIBROMATOSIS Type 1 CUTANEOUS NEUROFIBROMAS DICLOFENAC Sodium
• 年，卷（期）: 2015,（12）
• 页码范围: 975-983
• 页数: 9页
• 分类号: R73

摘要

The objectives of this study were to assess the safety and efficacy of intralesionally administered diclofenac in the treatment of cutaneous neurofibromas in patients with NF1. This was a proof-of-concept, prospective, safety and efficacy study of the effect of intralesionally administered diclofenac 25 mg/ml given once a week to 3 target cutaneous neurofibromas for 4 consecutive weeks. Overall, there was no significant change in neurofibroma size. During the study, some treated lesions developed signs of necrosis and fell off after a few weeks, but none of the control neurofibromas fell off. There were no significant changes in patient’s vital signs. A few adverse events occurred, mostly at the injection sites. During the study, some neurofibromas developed necrosis after the diclofenac injections and eventually detached from the patient. Overall, diclofenac was well tolerated, suggesting minimal systemic exposure, which required confirmation and further studies, including bioavailability analysis.