Resumo Objetivo: Determinar a incidência de nefropatia induzida por contraste intravenoso em pacientes hospitalizados submetidos a tomografia computadorizada (TC). Materiais e Métodos: Estudo de coorte retrospectivo que alocou 1.238 pacientes submetidos a TC sem ou com contraste (iopromida). O desfecho primário foi nefropatia induzida por contraste, definida pelo critério antigo - aumento absoluto ou relativo na creatinina sérica (SCr) ≥ 0,5 mg/dL ou ≥ 25%, respectivamente, durante 2-3 dias após a administração -, e o novo, Kidney Disease Improving Global Outcomes (KDIGO) - aumento absoluto ou relativo na SCr ≥ 0,3 mg/dL ou ≥ 50%, respectivamente, durante 2-7 dias após a administração. Resultados: A incidência de lesão renal aguda foi de 11,52% aplicando os critérios KDIGO. A regressão logística univariada demonstrou significância relacionada à associação entre aumento absoluto da SCr ≥ 0,5 mg/dL após TC e lesão renal aguda. A regressão logística multivariada encontrou, inicialmente, associação entre aumento absoluto da SCr ≥ 0,3 mg/dL após TC e idade avançada, mas a associação não foi mantida após correção. Não foi encontrada associação entre lesão renal aguda e os fatores de risco avaliados. Conclusão: Não foram encontrados critérios para nefropatia induzida por contraste após TC ou associação de lesão renal aguda com fatores de risco clássicos.

Abstract Objective: To determine the incidence of nephropathy induced by intravenous contrast in hospitalized patients undergoing computed tomography (CT). Materials and Methods: This was a retrospective cohort study involving 1,238 patients who underwent CT with or without intravenous administration of a contrast agent (iopromide). The primary outcome measure was acute kidney injury (AKI), as defined by the traditional criteria-an absolute or relative increase in serum creatinine (SCr) ≥ 0.5 mg/dL or ≥ 25% over baseline, respectively, at 2-3 days after contrast administration-and the newer, Kidney Disease: Improving Global Outcomes (KDIGO) criteria-an absolute or relative increase in SCr ≥ 0.3 mg/dL or ≥ 50% over baseline, respectively, at 2-7 days after contrast administration. Results: The overall incidence of AKI was 11.52% when the KDIGO criteria were applied. Univariate logistic regression demonstrated a significant association between an absolute post-CT increase in SCr ≥ 0.5 mg/dL and AKI, although that association did not retain significance in the multivariate analysis. Multivariate logistic regression initially found an association between an absolute post-CT increase in SCr ≥ 0.3 mg/dL and advanced age, although that association was not maintained after correction. We found no association between AKI and the risk factors evaluated. Conclusion: We identified no criteria for contrast-induced nephropathy after CT; nor did we find AKI to be associated with the classical risk factors.

ABSTRACT Polymeric stabilizers have received attention in the preparation of nanostructured systems due to their ability to enhance formulation stability. Considering this, the objective of this work was to prepare poly(ε-caprolactone) nanocapsules using the pullulan as a polymeric stabilizer. The nanocapsules were prepared using the interfacial deposition method of preformed polymers and they were characterized in terms of pH, average diameter, polydispersity index, zeta potential, beclomethasone dipropionate content, encapsulation efficiency, photostability and drug release profiles. The formulations showed physicochemical characteristics consistent with nanocarriers for drug delivery such as: average diameter lower than 270 nm, polydispersity indexes lower than 0.2, negative zeta potential (-22.7 to -26.3 mV) and encapsulation efficiencies close to 100%. In addition, the nanocapsules were able to delay the beclomethasone dipropionate photodegradation under UVC radiation and by the dialysis bag diffusion technique, the nanocapsules were able to prolong the drug release. Thus, pullulan could be considered an interesting excipient to formulate polymeric nanocapsules.

resumo Um método simples de CLAE-FR/UV indicativo de estabilidade foi validado para a determinação do dipropionato de beclometasona (BD) em suspensões de nanocápsulas. As condições cromatográficas foram: coluna C18 fase reversa (250 mm x 4,60 mm, 5 µm, 110 Å), usando como fase móvel metanol e água (85:15 v/v) a 1,0 mL/min, com detecção UV a 254 nm. A curva de calibração foi linear no intervalo de 5,0-25,0 µg/mL com coeficiente de correlação >0,999. A precisão foi demonstrada por um desvio padrão relativo menor que 2,0%. A exatidão foi avaliada pelo teste de recuperação do BD a partir das nanocápsulas (98,03% a 100,35%). O teste de especificidade não mostrou interferência dos componentes das nanocápsulas e nem dos produtos de degradação derivados de condições ácidas, básicas e fotolíticas. Em conclusão, o método é adequado para ser aplicado na avaliação do BD puro e em nanocápsulas e pode ser empregado para o estudo de estabilidade e degradação cinética.

abstract A simple stability-indicating RP-HPLC/UV method was validated for determination of beclomethasone dipropionate (BD) in nanocapsule suspensions. Chromatographic conditions consisted of a RP C18column (250 mm x 4.60 mm, 5 µm, 110 Å), using methanol and water (85:15 v/v) as mobile phase at 1.0 mL/min with UV detection at 254 nm. The calibration curve was found to be linear in the concentration range of 5.0-25.0 µg/mL with a correlation coefficient > 0.999. Precision was demonstrated by a relative standard deviation lower than 2.0%. Accuracy was assessed by the recovery test of BD from nanocapsules (98.03% to 100.35%). Specificity showed no interference from the components of nanocapsules or from the degradation products derived from acid, basic and photolytic conditions. In conclusion, the method is suitable to be applied to assay BD in bulk drug and in nanocapsules, and it can be employed to study stability and degradation kinetics.