RESUMO
BACKGROUND: The nasal vaccine candidate (NASVAC), comprising hepatitis B virus (HBV) surface (HBsAg) and core antigens (HBcAg), has been shown to be highly immunogenic in animal models. METHODS: A phase I double-blinded, placebo-controlled randomized clinical trial was carried out in 19 healthy male adults with no serologic markers of immunity/infection to HBV. This study was aimed at exploring the safety and immunogenic profile of nasal co-administration of both HBV recombinant antigens. The trial was performed according to Good Clinical Practice guidelines. Participants ranged in age from 18 to 45 years and were randomly allocated to receive a mixture of 50 microg HBsAg and 50 microg HBcAg or 0.9% physiologic saline solution, as a placebo, via nasal spray in a five-dose schedule at 0, 7, 15, 30, and 60 days. A total volume of 0.5 ml was administered in two dosages of 125 microl per nostril. Adverse events were actively recorded 1 h, 6 h, 12 h, 24 h, 48 h, 72 h, 7 days and 30 days after each dose. Anti-HBs and anti-HBc titers were evaluated using corresponding ELISA kits at days 30 and 90. RESULTS: The vaccine candidate was safe and well tolerated. Adverse reactions included sneezing (34.1%), rhinorrhea (12.2%), nasal stuffiness (9.8%), palate itching (9.8%), headache (9.8%), and general malaise (7.3%). These reactions were all self-limiting and mild in intensity. No severe or unexpected events were recorded during the trial. The vaccine elicited anti-HBc seroconversion in 100% of subjects as early as day 30 of the immunization schedule, while a seroprotective anti-HBs titer (>or=10 IU/l) was at a maximum at day 90 (75%). All subjects in the placebo group remained seronegative during the trial. CONCLUSION: The HBsAg-HBcAg vaccine candidate was safe, well tolerated and immunogenic in this phase I study in healthy adults. To our knowledge, this is the first demonstration of safety and immunogenicity for a nasal vaccine candidate comprising HBV antigens.
Assuntos
Antígenos do Núcleo do Vírus da Hepatite B/imunologia , Antígenos de Superfície da Hepatite B/imunologia , Vacinas contra Hepatite B/administração & dosagem , Vírus da Hepatite B/imunologia , Hepatite B/prevenção & controle , Administração Intranasal , Adolescente , Adulto , Método Duplo-Cego , Hepatite B/imunologia , Hepatite B/virologia , Anticorpos Anti-Hepatite B/imunologia , Antígenos do Núcleo do Vírus da Hepatite B/genética , Antígenos de Superfície da Hepatite B/genética , Vacinas contra Hepatite B/efeitos adversos , Vírus da Hepatite B/genética , Humanos , Imunidade nas Mucosas/imunologia , Masculino , Pessoa de Meia-Idade , Vacinas Combinadas/administração & dosagem , Vacinas Combinadas/efeitos adversos , Vacinas Sintéticas/administração & dosagem , Vacinas Sintéticas/efeitos adversosRESUMO
INTRODUCTION: A significant number of patients who have had cerebrovascular illness apparently recover their former abilities completely but return to normal life with subtle cognitive deficits which may affect their daily lives. Such is the situation of patients with transitory ischemic accidents who present with sustained, undiagnosed attention deficits. OBJECTIVES: To identify subclinical alterations due to attention deficits in patients with transitory ischemic accidents, and to contribute to the study of the physiopathological mechanisms involved in the integration of this function. PATIENTS AND METHODS: We examined 44 persons, divided into three groups for this study: one group had vertebro-basilar transitory ischemic accidents, a second group had supratentorial infarct and a third was healthy. All were given a specially designed computerized test of continuous work to evaluate the sustained attention component. RESULTS: Significant differences were found between the transitory ischemic accidents and healthy groups, regarding the variables including correct answers, omissions and indications of attention. This was not seen with the variables involving reaction time and number of errors. This demonstrated the existence of attention disorders involving omission in the group of patients with transitory ischemic accidents. CONCLUSION: These findings suggest the hypothesis that in the vertebro-basilar region there are important mechanisms involved in the process of sustained attention.
Assuntos
Atenção , Ataque Isquêmico Transitório/psicologia , Insuficiência Vertebrobasilar/psicologia , Doença Aguda , Idoso , Atenção/fisiologia , Dano Encefálico Crônico/etiologia , Dano Encefálico Crônico/psicologia , Tronco Encefálico/fisiopatologia , Infarto Cerebral/complicações , Infarto Cerebral/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
Los lipomas al igual que la mayoria de los tumores benignos de laringe, son infrecuentes. Se originan más comunmente en areas con abundantes depositos de grasa, principalmente la epiglotis y los pliegues ariepigloticos. Son de lento crecimiento y pueden causar obstrucción respiratoria, especialmente cuando son pediculados. El tratamiento es la extirpación quirurgica total, por via endoscopica o por abordaje externo. Se presenta el caso de un paciente de 59 años de edad, sexo masculino, quien consulto por sintomatologia progresiva de disnea y disfagia leves. Al examen laringoscopico indirecto, se observó una masa lisa, amarillenta a nivel del pliegue ariepiglotico derecho, ocultando parcialmente la glotis. La tomografia computarizada mostro una masa homogenea de baja densidad en pliegue ariepiglotico derecho. Se practicó resección submucosa de la masa por microcirugia endolaringea, cuyo estudio anatomo-patologico se informo como lipoma