RESUMO
INTRODUCTION: Erythema nodosum leprosum (ENL) is an immunological complication of leprosy. ENL results in morbidity and disability and if it is not treated can lead to death. The current treatment consists of thalidomide or high doses of oral corticosteroids for prolonged periods. Thalidomide is not available in many leprosy endemic countries. The use of corticosteroids is associated with morbidity and mortality. Identifying treatment regimens that reduce the use of corticosteroids in ENL is essential. Methotrexate (MTX) is used to treat many inflammatory diseases and has been used successfully to treat patients with ENL not controlled by other drugs, including prednisolone and thalidomide. We present the protocol of the 'MTX and prednisolone study in ENL' (MaPs in ENL) a randomised controlled trial (RCT) designed to test the efficacy of MTX in the management of ENL. METHODS AND ANALYSIS: MaPs in ENL is an international multicentre RCT, which will be conducted in leprosy referral centres in Bangladesh, Brazil, Ethiopia, India, Indonesia and Nepal. Patients diagnosed with ENL who consent to participate will be randomly allocated to receive 48 weeks of weekly oral MTX plus 20 weeks of prednisolone or 48 weeks of placebo plus 20 weeks of prednisolone. Participants will be stratified by type of ENL into those with acute ENL and those with chronic and recurrent ENL. The primary objective is to determine whether MTX reduces the requirement for additional prednisolone. Patients' reported outcome measures will be used to assess the efficacy of MTX. Participants will be closely monitored for adverse events. ETHICS AND DISSEMINATION: Results will be submitted for publication in peer-reviewed journals. Ethical approval was obtained from the Observational/Interventions Research Ethics Committee of the London School of Hygiene & Tropical Medicine (15762); The Leprosy Mission International Bangladesh Institutional Research Board (in process); AHRI-ALERT Ethical Review Committee, Ethiopia; Ethics Committee of the Managing Committee of the Bombay Leprosy Project; and The Leprosy Mission Trust India Ethics Committee; the Nepal Health and Research Council and Health Research Ethics Committee Dr. Soetomo, Indonesia. This study is registered at www.clinicaltrials.gov. This is the first RCT of MTX for ENL and will contribute to the evidence for the management of ENL.Trial registration numberNCT 03775460.
Assuntos
Eritema Nodoso , Hanseníase Virchowiana , Metotrexato/uso terapêutico , Prednisolona/uso terapêutico , Bangladesh , Brasil , Eritema Nodoso/tratamento farmacológico , Etiópia , Humanos , Índia , Indonésia , Hansenostáticos/uso terapêutico , Hanseníase Virchowiana/tratamento farmacológico , Londres , NepalRESUMO
A sífilis é uma doença infectocontagiosa de alta prevalência, especialmente nos países em desenvolvimento, e costuma ser denominada a "grande imitadora",devido seu polimorfismo lesional. A divisão da doença em fases é apenas didática e tem importância no manejo terapêutico, entretanto a sífilis deve ser tratada como doença dinâmica, pela possibilidade de sobreposição de seus estágios. Os autores relatam dois casos em que há concomitância do primarismo com o secundarismo sifilítico e enfatizam a importância da avaliação global do paciente em DST.
Syphilis is an infectious disease of high prevalence, especially in underdeveloped countries, and is often called the "great imitator" due to its versatile andvaried disease presentations. The disease's division into stages is only didactic and has importance in the therapeutic management, however syphilis should be managed as a dynamic disease, due to its possibility of overlapping stages. The authors report two cases in which there is concomitance of primary and secondary syphilis and emphasize the importance of patient global assessment in STD.