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

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International Journal of Clinical Medicine 2015年第12期6卷 975-983页

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 Immunology Department Fundacao Educacional Serra dos Orgaos(UNIFESO)TeresopolisBrazil Clinical Immunology Instituto de Pos-Graduacao Medica Carlos Chagas(IPGMCC)Rio de JaneiroBrazil Medical Genetics Service IPPMG-Universidade Federal Rio de JaneiroRio de JaneiroBrazil Hospital Naval Marcilio Dias Rio de JaneiroBrazil Sociedade Evangelica Beneficiente de Curitiba Outpatient Unit CuritibaBrazil NYU Langone Medical Center New YorkNYUSA Bone Marrow Transplant Unit Hospital das Clinicas da Faculdade de Medicina de Ribeirao PretoUniversidade de Sao Paulo(USP)Ribeirao PretoBrazil Pontifica Universidade Catolica do Rio de Janeiro(PUC-RJ) Rio de JaneiroRJBrazil Plastic Surgery Post-Graduation PUC-RJRio de JaneiroBrazil 1 Universidade Federal Fluminense(UFF) Rio de JaneiroBrazil

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

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