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

作　　者：Mauro Geller Aguinaldo Bonalumi Filho Lisa Oliveira Allan ERubenstein Luiz Guilherme Darrigo Jr David Azulay Allan Bernacchi Marcia Goncalves Ribeiro Karin Soares Goncalves Cunha 

机构地区：[1]Immunology Department,Fundacao Educacional Serra dos Orgaos(UNIFESO),Teresopolis,Brazil [2]Clinical Immunology,Instituto de Pos-Graduacao Medica Carlos Chagas(IPGMCC,)Rio de Janeiro,Brazil [3]Medical Genetics Service,IPPMG-Universidade Federal Rio de Janeiro,Rio de Janeiro,Brazil [4]Hospital Naval Marcilio Dias,Rio de Janeiro,Brazil [5]Sociedade Evangelica Beneficiente de Curitiba Outpatient Unit,Curitiba,Brazil [6]NYU Langone Medical Center,New York,NY,USA [7]Bone Marrow Transplant Unit,Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto,Universidade de Sao Paulo(USP),Ribeirao Preto,Brazil [8]Pontifica Universidade Catolica do Rio de Janeiro(PUC-RJ),Rio de Janeiro,RJ,Brazil [9]Plastic Surgery Post-Graduation,PUC-RJ,Rio de Janeiro,Brazil 1 [10]Universidade Federal Fluminense(UFF),Rio de Janeiro,Brazil

出　　处：《International Journal of Clinical Medicine》2015年第12期975-983,共9页临床医学国际期刊（英文）

基　　金：UNIFESO

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.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.

关 键 词：Neurofibromatosis Type 1 Cutaneous Neurofibromas Diclofenac Sodium 

分 类 号：R73[医药卫生—肿瘤]