Descrição clínica e sóciodemográfica de pacientes internados em uma unidade de pacientes graves de Cabo Frio-RJ / Clinical and social demographic description of patients within a serious Cabo Frio patient unit / Descripción demográfica clínica y social de los pacientes dentro de una unidad de pacientes en Cabo Frio seria

O objetivo deste estudo foi caracterizar o perfil clínico-epidemiológico e sociodemográfico dos pacientes adultos internados na Unidade de Pacientes Graves de um hospital público do Município de Cabo Frio - RJ. Trata-se de um estudo retrospectivo de abordagem quantitativo. Houve uma predominância de idosos (48,8%), do sexo masculino (55%), branco (44,1%), aposentado (30,4%), com ensino fundamental (9%). Com maior quantitativo de pacientes neurológicos (34,5%), portadores de hipertensão Arterial Sistêmica (77,7%), proveniente das unidades de emergências (70%) e com média de internação na unidade de 1-10 dias. O perfil encontrado da região deve ser levado em consideração para tomada de decisão no que tange a investimento assistencial, bem como torna-se fundamental a execução de mais pesquisas relacionada a temática.(AU)

The aim of this study was to characterize the clinical-epidemiological and sociodemographic profile of adult patients admitted to the Serious Patients Unit of a public hospital in Cabo Frio - RJ. This is a retrospective study of quantitative approach. There was a predominance of elderly (48.8%), male (55%), white (44.1%), retired (30.4%), with elementary education (9%). With a larger number of neurological patients (34.5%), patients with systemic arterial hypertension (77.7%), coming from emergency units (70%) and with an average stay of 1-10 days. The profile found in the region should be taken into consideration when making decisions regarding assistance investment, and it is essential to carry out more research related to the theme.(AU)

El objetivo de este estudio fue caracterizar el perfil clínico-epidemiológico y sociodemográfico de pacientes adultos ingresados en la Unidad de Pacientes Graves de un hospital público en Cabo Frio - RJ. Este es un estudio retrospectivo de enfoque cuantitativo. Hubo un predominio de ancianos (48.8%), hombres (55%), blancos (44.1%), jubilados (30.4%), con educación primaria (9%). Con un mayor número de pacientes neurológicos (34.5%), pacientes con hipertensión arterial sistémica (77.7%), provenientes de unidades de emergencia (70%) y con una estadía promedio de 1-10 días. El perfil que se encuentra en la región debe tenerse en cuenta al tomar decisiones con respecto a la inversión en asistencia, y es esencial llevar a cabo más investigaciones relacionadas con el tema.(AU)

Using a single tablet daily to treat latent tuberculosis infection in Brazil: bioequivalence of two different isoniazid formulations (300 mg and 100 mg) demonstrated by a sensitive and rapid high-performance liquid chromatography-tandem mass spectrometry method in a randomised, crossover study

The recommended treatment for latent tuberculosis (TB) infection in adults is a daily dose of isoniazid (INH) 300 mg for six months. In Brazil, INH was formulated as 100 mg tablets. The treatment duration and the high pill burden compromised patient adherence to the treatment. The Brazilian National Programme for Tuberculosis requested a new 300 mg INH formulation. The aim of our study was to compare the bioavailability of the new INH 300 mg formulation and three 100 mg tablets of the reference formulation. We conducted a randomised, single dose, open label, two-phase crossover bioequivalence study in 28 healthy human volunteers. The 90% confidence interval for the INH maximum concentration of drug observed in plasma and area under the plasma concentration vs. time curve from time zero to the last measurable concentration “time t” was 89.61-115.92 and 94.82-119.44, respectively. The main limitation of our study was that neither adherence nor the safety profile of multiple doses was evaluated. To determine the level of INH in human plasma, we developed and validated a sensitive, simple and rapid high-performance liquid chromatography-tandem mass spectrometry method. Our results showed that the new formulation was bioequivalent to the 100 mg reference product. This finding supports the use of a single 300 mg tablet daily strategy to treat latent TB. This new formulation may increase patients’ adherence to the treatment and quality of life.

Development of a HPLC/MS/MS methodology for determining 3-O-methyldopa in human plasma and its application in a bioequivalence study

A simple, sensitive and specific HPLC/MS/MS methodology was developed and it was validated for determining 3-O-methyldopa, the major metabolite of dopamine, in human plasma. The separation was achieved on Atlantis T3 C18 analytical column (5 μm; 150 x 4.6 mm i.d.) using a mobile phase consisted of a solution of water and methanol (85:15, v/v) and containing formic acid 0.05 %. The extraction from the analyte and the internal standard sample was performed using a simple protein plasma precipitation with perchloric acid. The detection was conducted on a triple quadrupole tandem mass spectrometer with a positive multiple reaction monitoring mode (MRM). The monitored fragmentation transitions were m/z212.0  m/z 166.0 for 3-O-methyldopa and m/z 227.10  m/z 181.0 for carbidopa (internal standard).The calibration curves were linear in the range of 50–4000 ng/mL for 3-O-methyldopa. The methodology presented a good precision and accuracy in accordance to the criteria for biomedical analysis. And it was successfully applied to the bioequivalence study of two formulations levodopa + benserazide (200 + 50mg) in plasma samples from healthy human volunteers, following the ANVISA guidelines...