RESUMO
BACKGROUND: Xigris (recombinant human activated protein C) has recently been introduced as a treatment for severe sepsis following a large multicentre trial (the PROWESS trial). MATERIAL AND METHODS: Critical review of the original paper, follow-up studies and commentaries, and subgroup analyses from the US Food and Drug Administration. RESULTS: Changes in trial design after the start of the trial as well as inconsistent results in two phases of the trial make interpretation difficult. The overall trial results indicate a small benefit from treatment with activated protein C. However, subgroup analysis reveals that several groups of patients appeared to have little benefit. The drug may have severe and potentially lethal side effects in some patients. INTERPRETATION: Although activated protein C may have beneficial effects in some patients with severe sepsis, the effect on different subgroups of patients remains to be clarified. We conclude that there is at present insufficient documentation for a recommendation of activated protein C in patients with severe sepsis.
Assuntos
Anti-Inflamatórios/uso terapêutico , Fibrinolíticos/uso terapêutico , Proteína C/uso terapêutico , Proteínas Recombinantes/uso terapêutico , Sepse/tratamento farmacológico , Animais , Anti-Inflamatórios/efeitos adversos , Anticoagulantes/uso terapêutico , Ensaios Clínicos como Assunto , Quimioterapia Combinada , Fibrinolíticos/efeitos adversos , Seguimentos , Heparina/uso terapêutico , Humanos , Proteína C/efeitos adversos , Proteínas Recombinantes/efeitos adversos , Sepse/mortalidadeAssuntos
Acetamidas/administração & dosagem , Antibacterianos/administração & dosagem , Anti-Infecciosos/administração & dosagem , Infecções Bacterianas/tratamento farmacológico , Oxazolidinonas/administração & dosagem , Acetamidas/efeitos adversos , Administração Oral , Antibacterianos/efeitos adversos , Anti-Infecciosos/efeitos adversos , Infecções Bacterianas/microbiologia , Hipersensibilidade a Drogas , Monitoramento de Medicamentos , Farmacorresistência Bacteriana Múltipla , Uso de Medicamentos , Feminino , Humanos , Linezolida , Masculino , Noruega , Oxazolidinonas/efeitos adversos , Infecções Estafilocócicas/tratamento farmacológico , Infecções Estreptocócicas/tratamento farmacológicoRESUMO
BACKGROUND: Quality audits of the implementation of drug administration procedures are carried out in order to determine objectively to what extent implementation conforms to procedures. METHODS: Since September 1997, the pharmacy at Rikshospitalet University Hospital in Norway has performed quality audits of drug administration at the hospital, using interviews and surveys. Staff members in the audited unit and the auditing pharmacist agree on prospects for quality improvements and review possible action. A survey was carried out in the autumn of 2000 in order to determine staff opinion of the quality audits. RESULTS: On the basis of the observations made, improvements have been carried out at all levels of the organisation. INTERPRETATION: The survey indicates that hospital staff members are satisfied with the quality audits performed by the pharmacy.