ABSTRACT
OBJECTIVES: To evaluate the efficacy of oral colistin-neomycin in preventing multidrug-resistant Enterobacterales (MDR-E) infections in solid organ transplant (SOT) recipients. METHODS: Multicentre, open-label, parallel-group, controlled trial with balanced (1:1) randomization in five transplant units. SOT recipients were screened for MDR-E intestinal colonization (extended-spectrum ß-lactamase or carbapenemase producing) before transplantation and +7 and + 14 days after transplantation and assigned 1:1 to receive treatment with colistin sulfate plus neomycin sulfate for 14 days (decolonization treatment (DT) group) or no treatment (no decolonization treatment (NDT) group). The primary outcome was diagnosis of an MDR-E infection. Safety outcomes were appearance of adverse effects, mainly diarrhoea, rash, nausea and vomiting. Patients were monitored weekly until 30 days after treatment. Intention-to-treat analysis was performed. RESULTS: MDR-E rectal colonization was assessed in 768 SOT recipients; 105 colonized patients were included in the clinical trial, 53 receiving DT and 52 NDT. No significant decrease in the risk of infection by MDR-E was observed in the DT group (9.4%, 5/53) compared to the NDT group (13.5%, 7/52) (relative risk 0.70; 95% confidence interval 0.24-2.08; p 0.517). Four patients (5.6%), three (5.6%) in the DT group and one (1.9%) in the NDT group, developed colistin resistance. Twelve patients (22.7%) in the DT group had diarrhoea, eight related to treatment (15.0%); one patient (1.8%) developed skin rash and another (1.8%) nausea and vomiting. Two patients (3.8%) in the NDT group developed diarrhoea. CONCLUSIONS: DT does not reduce MDR-E infections in SOT. Colistin resistance and adverse effects such as diarrhoea are a potential issue that must be taken seriously.
Subject(s)
Anti-Bacterial Agents/therapeutic use , Carrier State , Colistin/therapeutic use , Enterobacteriaceae/drug effects , Neomycin/therapeutic use , Transplant Recipients , Administration, Oral , Aged , Anti-Bacterial Agents/administration & dosage , Colistin/administration & dosage , Drug Resistance, Multiple, Bacterial , Drug Therapy, Combination , Enterobacteriaceae Infections/microbiology , Enterobacteriaceae Infections/prevention & control , Female , Humans , Male , Middle Aged , Neomycin/administration & dosage , Organ Transplantation , Rectum/microbiologyABSTRACT
INTRODUCCIÓN: El trasplante hepático constituye la única alternativa de tratamiento en pacientes con hepatopatías crónicas avanzadas. La etiología más frecuente en nuestro medio es la viral y la alcohólica. El objetivo de nuestro estudio fue determinar si los pacientes que son candidatos a un trasplante hepático precisan una exploración de cabeza y cuello de forma sistemática para descartar neoplasias de dicha área. PACIENTES Y MÉTODOS: Todos los pacientes candidatos a la realización de un trasplante hepático entre los años 2011 y 2017 fueron incluidos en nuestro estudio. A todos ellos se les realizó de forma sistemática una exploración de cabeza y cuello por un otorrinolaringólogo para descartar neoplasias de cabeza y cuello. RESULTADOS: Un total de 141 pacientes fueron incluidos en nuestro estudio. En 2 de ellos (1,3%) se detectó un carcinoma de cabeza y cuello (uno de orofaringe y otro de laringe), estando ambos pacientes asintomáticos. Fueron tratados con quimiorradioterapia, falleciendo uno de ellos durante el seguimiento por la aparición de un tumor metacrónico pulmonar. El otro paciente está libre de enfermedad 2 años después del diagnóstico, pero no ha recibido trasplante hepático hasta la fecha. Ambos pacientes tenían antecedentes de tabaquismo y alta ingesta de alcohol. CONCLUSIONES: En pacientes que son candidatos a un trasplante hepático, y que presentan antecedentes de tabaquismo y/o alta ingesta alcohólica recomendamos la realización de un estudio de cabeza y cuello pretrasplante que incluya exploración nasofibroscópica de las regiones faringolaríngeas para despistaje de tumores sincrónicos
INTRODUCTION: Liver transplantation is the only alternative treatment in patients in end-stage liver function. In many cases the need for liver transplantation is a consequence of the toxic effects of alcohol.The aim of our study was to determine if patients who are candidates for a liver transplant require a systematic exploration of the head and neck to rule out malignant lesions in this area. PATIENTS AND METHODS: All the candidates for a liver transplant, between 2011 and 2017, were included in our study. All of them underwent a systematic exploration of the head and neck by an otolaryngologist to rule out malignancy of the head and neck. RESULTS: A total of 141 patients were included in our study. In 2 of them (1.3%) a carcinoma of the head and neck was detected (one of the oropharynx and the other of the larynx). Both patients were asymptomatic from an ENT point of view. They were treated with chemoradiotherapy. One of them died during follow-up due to the appearance of a metachronous lung tumour. The other is free of disease 2 years after diagnosis but without having been transplanted. Both patients had a history of smoking and high alcohol intake. CONCLUSIONS: In patients who are candidates for a liver transplant who have a history of smoking and / or high alcohol intake, a pretransplant head and neck study including pharyngo-laryngeal fibroscopy is indicated
Subject(s)
Humans , Male , Middle Aged , Liver Transplantation/methods , Squamous Cell Carcinoma of Head and Neck/diagnosis , Head and Neck Neoplasms/diagnosis , Retrospective Studies , Risk Factors , Preoperative Period , Squamous Cell Carcinoma of Head and Neck/pathology , Head and Neck Neoplasms/pathology , Early Detection of CancerABSTRACT
INTRODUCTION: Liver transplantation is the only alternative treatment in patients in end-stage liver function. In many cases the need for liver transplantation is a consequence of the toxic effects of alcohol. The aim of our study was to determine if patients who are candidates for a liver transplant require a systematic exploration of the head and neck to rule out malignant lesions in this area. PATIENTS AND METHODS: All the candidates for a liver transplant, between 2011 and 2017, were included in our study. All of them underwent a systematic exploration of the head and neck by an otolaryngologist to rule out malignancy of the head and neck. RESULTS: A total of 141 patients were included in our study. In 2 of them (1.3%) a carcinoma of the head and neck was detected (one of the oropharynx and the other of the larynx). Both patients were asymptomatic from an ENT point of view. They were treated with chemoradiotherapy. One of them died during follow-up due to the appearance of a metachronous lung tumour. The other is free of disease 2 years after diagnosis but without having been transplanted. Both patients had a history of smoking and high alcohol intake. CONCLUSIONS: In patients who are candidates for a liver transplant who have a history of smoking and / or high alcohol intake, a pretransplant head and neck study including pharyngo-laryngeal fibroscopy is indicated.
