Eficácia e segurança de mebutato de ingenol no tratamento da queratose actínica: Revisão sistemática e meta-análise.

João Costa; Rita Sousa; Joana Alarcão; António Vaz Carneiro; Paulo Filipe

doi:10.29021/spdv.72.2.243

João Costa Centro de Estudos de Medicina Baseada na Evidência (CEMBE). Laboratório de Farmacologia Clínica e Terapêutica. Faculdade Medicina Universidade Lisboa.
Rita Sousa Centro de Estudos de Medicina Baseada na Evidência (CEMBE). Faculdade Medicina Universidade Lisboa.
Joana Alarcão Centro de Estudos de Medicina Baseada na Evidência (CEMBE). Laboratório de Farmacologia Clínica e Terapêutica. Faculdade Medicina Universidade Lisboa.
António Vaz Carneiro Centro de Estudos de Medicina Baseada na Evidência (CEMBE). Laboratório de Farmacologia Clínica e Terapêutica. Faculdade Medicina Universidade Lisboa.
Paulo Filipe 3. Serviço de Dermatologia do Centro Hospitalar Lisboa Norte e Unidade de Investigação em Dermatologia. Instituto de Medicina Molecular. Faculdade de Medicina. Universidade de Lisboa. Lisboa, Portugal.

DOI: https://doi.org/10.29021/spdv.72.2.243

Abstract

Introdução: A queratose actínica é a lesão pré-maligna mais frequente. A abordagem terapêutica dos doentes com múltiplas lesões envolve terapêuticas de campo.

Objetivo: Avaliar a eficácia e segurança de mebutato de ingenol, um novo medicamento destinado à terapêutica tópica de campo.

Desenho: Revisão sistemática e meta-análise dos ensaios clínicos controlados e aleatorizados (RCTs).

Fontes bibliográficas: Medline e Cochrane Library (junho 2014).

Seleção dos estudos: A seleção e avaliação dos RCTs foram feitas de forma independente.

Análise quantitativa: Meta-análise de efeitos aleatórios. A heterogeneidade foi avaliada com o teste I² .

Resultados: Foram incluídos 6 ensaios (n=1.492) versus placebo. Mebutato de ingenol esteve associado a uma possibilidade de um doente ter remoção completa das lesões 17 (IC95%: 9 a 31; I²=0%) e 8,5 (IC95%: 5 a 15; I²=0%) vezes superior, comparativamente ao placebo, no rosto/couro cabeludo e no tronco/extremidades, respetivamente. A incidência de eventos adversos relacionados com o tratamento foi superior no grupo mebutato de ingenol (+23%, IC95%: 11 a 35%), sem diferenças entre grupos na taxa de abandono por eventos adversos.

Conclusões: Mebutato de ingenol é eficaz no tratamento da queratose actínica. Comparativamente às restantes terapêuticas de campo disponíveis em Portugal, o seu valor terapêutico advém do favorável perfil de segurança e tolerabilidade, da simplicidade e curta duração do esquema terapêutico e da possibilidade de tratar de forma diferenciada as lesões de acordo com a localização anatómica (individualização da terapêutica).Estudos futuros deveriam comparar diretamente as diferentes opções terapêuticas e avaliar a efetividade das mesmas no mundo real.

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Author Biographies

João Costa, Centro de Estudos de Medicina Baseada na Evidência (CEMBE). Laboratório de Farmacologia Clínica e Terapêutica. Faculdade Medicina Universidade Lisboa.

João Costa was born on 1974 in Portugal. He receive is licensure in Medicine (School of Medicine, University of Lisbon) in 1998 and he practice as a General practitioner between 1999 to 2000. In 2006 he became specialist in neurology and later on in clinical neurophysiologist and in clinical pharmacology. He received clinical research training in the Walton Centre for Neurology and Neurosurgery (WCNN) NHS Trust, Liverpool, UK and in the Neurology Department of the Hospital Clínic of Barcelona, Spain. Currently he practice medicine in Hospital da Luz, Lisbon, Portugal. After finishing his licensure, he got the following academic degrees and titles: Master of Neurosciences (University of Lisbon); Master of Neurological electrodiagnosis (University of Barcelona); and Doctor of Medicine, Discipline of Neurology (University of Lisbon). He had a Postdoctoral Research Fellowship by CIBERNED to work for a year at Hospital Clínic of Barcelona, Spain. His major current positions are: Professor of Clinical Pharmacology and Therapeutics at School of Medicine, University of Lisbon; Coordinator Editor of the Cochrane Movement Disorders Group; Coordinator Director of the Portuguese Cochrane Branch of the Iberoamerican Cochrane Network; Principal Investigator at the Clinical Pharmacology Unit and at the Translational Clinical Physiology Unit of the Institute of Molecular Medicine (Lisbon, Portugal), and Member of the Clinical Pharmacology College of the Portuguese General Medical Council. He is ad-hoc reviewer for 12 international journals. He has published 110 full papers in peer review journals. He presented 144 communications at scientific conferences. He has written 5 book chapters and 7 national clinical guidelines. He has received 10 Awards and Distinctions as first author/investigator by national and international institutions.

António Vaz Carneiro, Centro de Estudos de Medicina Baseada na Evidência (CEMBE). Laboratório de Farmacologia Clínica e Terapêutica. Faculdade Medicina Universidade Lisboa.

António Vaz Carneiro, MD, PhD, FACP

FACULTY OF MEDICINE UNIVERSITY OF LISBON
Head, Center for Evidence Based Medicine

Executive-Director, Institute for Advanced Education - Head, Main Library - Center for Information and Documentation

Chair, BEME Review Editorial Board, AMEE

Director, Portuguese Collaborating Center of the Iberoamerican Cochrane Network

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