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Os autores apresentam e discutem o potencial dos ensaios clínicos pragmáticos como uma alternativa aos ensaios clínicos explanatórios e aos estudos observacionais (Ex.: coorte, caso-controle) para obtenção de evidências que justifiquem o uso de intervenções terapêuticas. Argumentam que tal estratégia, quando utilizada num contexto adequado, constitui uma poderosa ferramenta para a identificação de medidas não viesadas de efetividade, com logística mais simples e custo inferior ao dos ensaios clínicos hoje utilizados.

Apesar das recomendações contra o uso prolongado de benzodiazepínicos em idosos, as pesquisas indicam que o uso desses medicamentos aumenta com a idade. O padrão de uso de benzodiazepínicos e os fatores associados ao uso prolongado destes foram examinados com base em um questionário padronizado, aplicado a 634 mulheres com mais de sessenta anos, participantes de um centro de convivência para idosos no Rio de Janeiro, entre maio de 1992 e dezembro de 1995. A prevalência de uso de benzodiazepínicos na última quinzena foi estimada em 21,3% (IC 95% 18,1-24,5), e a prevalência de uso diário por 12 meses ou mais em 7,4% (IC 95% 5,4-9,4). Em uma análise multivariada, o número de medicamentos consumidos mostrou uma associação importante e progressiva com o uso prolongado de benzodiazepínicos, com OR = 2,77 (IC 95% 1,17-6,57) para aquelas que consomem entre quatro a seis medicamentos e OR = 7,62 (IC 95% 3,18-18,26) para aquelas que consomem mais de sete medicamentos. Queixas de insônia (OR = 8,87 IC 95% 2,53-31,06) e cefaléia (OR = 3,53 IC 95% 1,82-6,89) também estiveram fortemente associadas a este padrão de uso.

Abstract Background Vancomycin is an antibiotic of growing importance in the treatment of hospital infections, with particular emphasis on its value in the fight against methicillin-resistant Staphylococcus aureus. However its usage profile must be evaluated to assure maximum benefit and minimum risk. Findings A cross-sectional retrospective study was carried out among inpatients that received vancomycin in a Brazilian quaternary hospital. The occurrence of adverse reactions reported was evaluated in medical records relating to patients taking vancomycin during a one year period. Males comprised 52% (95% CI: 41.7-60.2%) of the sample population, with a mean age of 50.6 (95% CI: 47.2-54.0) years and mean treatment period of 9.7 (95% CI: 8.0-11.5) Days. It was verified that nephrotoxicity occurred in 18.4% (95% CI: 11.3-27.5) of patients, Red man syndrome occurred in 2% (95% CI 0.2-7.2), while the occurrence of thrombocytopenia was 7.1% (95% CI: 2.9-14.2). Conclusions It may be noted that even after 50 years of use, adverse reactions associated with vancomycin continue with high frequency, presenting a public health problem, especially considering its current use in cases of multidrug resistant infections. In this context, we emphasize the importance of intensive pharmacovigilance in hospital as a surveillance tool after drug approval by the sanitary authority.

Abstract Background Sildenafil is a cyclic guanosine monophosphate-specific phosphodiesterase-5 inhibitor used for treating pulmonary hypertension. Although the use of sildenafil in patients under 18 years old is off-label, this inhibitor has been widely prescribed for children treatment at hospitals in Brazil. In this work we evaluated the current practices in using sildenafil in the three main reference hospitals of Rio de Janeiro to design a clinical trial. Then we analyzed the content of sildenafil in powder paper preparations used in these institutions. Methods and Results We assessed the data about the use of sildenafil in three reference hospitals including Instituto Nacional de Cardiologia – INC, Instituto Estadual de Cardiologia Aloysio de Castro – IECAC and Hospital Pro-Cardíaco – HPC. The pharmacy records were analyzed from April 1st, 2008 to April 30th, 2008 and interviews with the pharmacists were also performed. Our results showed that INC used the greatest amount of sildenafil in: treatment of pulmonary arterial hypertension (PAH), management of transient PAH during surgery, preparation for cardiac transplantation and haemodynamic studies during cardiac catheterization. Meanwhile IECAC and HPC used sildenafil only for treating PAH in few patients during the period evaluated. In INC and IECAC, sildenafil was available in tablets, and powder papers prepared by two private pharmacies and one public hospital pharmacy. In contrast all patients of HPC received sildenafil in tablets with no external manipulation. Our quantification analysis results using reverse-phase high performance liquid chromatography method showed that powder papers prepared by the private pharmacies from the sildenafil tablets presented only 58.5 to 89.3% of the declared concentration in contrast to samples from the public hospital pharmacy (104.4 to 105.3%). Conclusion Few patients received the prescribed sildenafil dose at the reference hospitals evaluated in Rio de Janeiro, which may importantly compromise this inhibitor effect in the current treatment. This study reinforced the need of checking the practices of preparing and administering sildenafil continually.