Hematological and dermatological adverse events during hepatitis C treatment with peg-interferon and ribavirin / Eventos adversos hematológicos e dermatológicos durante o tratamento da hepatite C com interferon peguilado e ribavirina

Objective: To evaluate frequency and impact of adverse events, mainly the hematological and dermatological ones, on sustained virological response, and compliance to hepatitis C treatment. Methods: Patients were treated according to the guidelines of the Brazilian Ministry of Health. Variables associated with hematological and dermatological adverse events were: age, gender, stage of fibrosis, type of Pegylated interferon, dose reductions, temporary discontinuation and early interruption of treatment. Results: Two hundred and twenty two patients were studied (58% females; age 49±11 years). Dose reductions, temporary interruptions, and early discontinuations were observed in 21%, 8% and 9.5% of patients, respectively. The main adverse events were hematological (anemia, neutropenia and thrombocytopenia) and dermatological (pruritus and alopecia). Anemia (Hemoglobin <10g/dL) was associated with female gender (p<0.001), advanced fibrosis (p=0.047) and dose reductions (p<0.001); neutropenia with advanced fibrosis (p=0.003) and temporary discontinuation (p=0.002); thrombocytopenia with advanced fibrosis (p<0.001) and pegylated interferon α2a (p=0.05). Pruritus and alopecia were associated to female gender (p=0.008 and p=0.02) and treatment interruption (p=0.029 and p=0.02).Conclusion: Hematological and dermatological adverse events are frequent in hepatitis C patients treated with pegylated interferon and ribavirin. However, despite frequent dose reductions and interruptions, these adverse events did not affect the sustained virological response.

Objetivo: Avaliar a frequência e o impacto de eventos adversos, principalmente hematológicos e dermatológicos, na resposta virológica sustentada e na aderência ao tratamento para hepatite C. Métodos: Os pacientes foram tratados de acordo com diretriz do Ministério da Saúde. Variáveis associadas com eventos adversos hematológicos e dermatológicos foram: idade, sexo, grau de fibrose, tipo de interferon peguilado, reduções de dose, descontinuação temporária e interrupção precoce do tratamento. Resultados: Foram estudados 232 pacientes (58% mulheres; idade 49±11 anos). Reduções de dose, interrupções temporárias e descontinuações precoces foram observadas em 21%, 8% e 9,5% dos pacientes, respectivamente. Os principais eventos adversos foram hematológicos (anemia, neutropenia e plaquetopenia) e dermatológicos (prurido e alopecia). Anemia (hemoglobina <10g/dL) se associou a sexo feminino (p<0,001), fibrose avançada (p=0,047) e reduções de doses (p<0,001); neutropenia com fibrose avançada (p=0,003) e interrupção temporária (p=0,002); plaquetopenia com fibrose avançada (p<0,001) e interferon peguilado α2a (p=0,05). Prurido e alopecia se associaram ao sexo feminino (p=0,008 e p=0,02) e interrupção do tratamento (p=0,029 e p=0,02). Conclusão: Eventos adversos hematológicos e dermatológicos foram frequentes em pacientes tratados com interferon peguilado e ribavirina. Entretanto, a despeito de frequentes reduções de dose e interrupções, estes eventos adversos não afetaram a resposta virológica sustentada.

Clinical assessment of azithromycin dihydrate in the treatment of pediatric impetigo / Avaliação clínica de azitromicina di-hidratada no tratamento de impetigo pediátrico

The primary objective of this double-blind, randomized, controlled clinical trial was to assess the use of azithromycin dihydrate in oral suspension form in the treatment of impetigo in children. The secondary objectives were to compare the efficacy and safety of two presentations of azithromycin dihydrate in the treatment of impetigo in children, on wound healing and on wound pruritus. After screening and obtaining informed consent of the parents or legal guardians, a total of 100 patients ranging in age from 2-8 years old and presenting impetigo were randomized to one of two groups for a 3-day treatment period using azithromycin dihydrate in oral suspension in single doses of 10mg/kg/day: Group A (manufactured by Merck S.A.), and Group B (manufactured by Pfizer). Patients returned to the study center at the end of the 3-day treatment (Visit 2) and 7 days after the Pretreatment visit (Visit 3) for efficacy assessments and safety monitoring. Pretreatment demographic data and impetigo characteristics (type, location, number of lesions, pruritus) were homogenous between treatment groups. At the end of the study, all patients in both groups presented either ?improvement? or ?cured? lesions, with the majority (72.9%) of the patients presenting ?cured? lesions. We observed a statistically significant decrease in pruritus severity at Visit 2 and Visit 3 in relation to pretreatment, with no significant between-group difference at either study visit. Reported adverse events were transient and mild-to moderate in severity in both treatment groups, with no serious adverse events reported during the study. Based on the data collected during this study, we conclude that the two presentations of azithromycin were safe and effective in the treatment of impetigo in the population evaluated.