RESUMO
Anidulafungin had demonstrated favorable efficacy versus fluconazole in a randomized trial on invasive Candida infections. Since patient characteristics in the post-approval use of antifungals likely deviate from clinical trials, we surveyed the use of anidulafungin in clinical routine. We performed a retrospective survey of the post-approval use of anidulafungin in 9 Austrian clinical centers. Anidulafungin was used in 129 critically ill patients with severe comorbidities and multiple risk factors. Indications were suspected invasive fungal infections (IFI) (61%), proven candidemia (19%), and at risk for IFI (prophylaxis, 20%). Candida colonization in conjunction with other risk factors prompted treatment in many patients. predominant pathogens were C. albicans, C. glabrata and C. krusei. Anidulafungin was mostly used for pre-emptive (69%) and first-line treatment (17%) of invasive candidiasis. Treatment response, i.e. complete response/stabilization as determined by investigators (89% in the overall population; 87% for documented candidemia) and survival rates (81% and 75%, respectively) were similar to previous trial data. No breakthrough IFI and few adverse events were reported. Overall, favorable clinical experiences were documented with anidulafungin in the clinical routine setting.
Assuntos
Antifúngicos/uso terapêutico , Candidíase/tratamento farmacológico , Candidíase/prevenção & controle , Equinocandinas/uso terapêutico , Padrões de Prática Médica , Anidulafungina , Antifúngicos/efeitos adversos , Áustria/epidemiologia , Candida/classificação , Candida/isolamento & purificação , Candidemia/tratamento farmacológico , Candidemia/epidemiologia , Candidemia/fisiopatologia , Candidemia/prevenção & controle , Candidíase/epidemiologia , Candidíase/fisiopatologia , Candidíase Invasiva/tratamento farmacológico , Candidíase Invasiva/epidemiologia , Candidíase Invasiva/fisiopatologia , Candidíase Invasiva/prevenção & controle , Comorbidade , Equinocandinas/efeitos adversos , Feminino , Humanos , Masculino , Prontuários Médicos , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Fatores de TempoRESUMO
OBJECTIVES: A comparison of data from different intensive care units (ICUs) needs standardized documentation. In this study the ASDI documentation standard for intensive care was tested in clinical practice. Goal of the study was to evaluate parameters and functionality required for a national, interdisciplinary documentation system for intensive care. DESIGN: 13 ICUs participated in a 4-week trial using the provided program for documentation of all admitted patients during the observation period. In addition, a questionnaire was distributed to the unit coordinators. RESULTS: 376 patients were documented in 1591 patient days. Valid SAPS II scores were found in only 29% of the discharged patients (39.1 +/- 15.5 points). Time needed for data entry exceeded preset limits (ten minutes per patient and day) in 38% of the cases. All participants affirmed the necessity of a documentation standard for intensive care, giving quality control and cost analysis as the most important reasons. CONCLUSION: The ASDI data set fitted existing needs very closely. Only 7 out of 122 parameters (5.7%) were found to be superfluous and thus removed. Measures to reduce documentation effort to the default limits were a) a new, date orientated concept for manual recording, b) rede-sign of the user interface with new, user friendly data entry possibilities, and c) the integration of statistical analysis and reports in the documentation system. The revised data set represents a broad-based consensus, which seems to be well-suited as foundation for the national quality assurance program.