RESUMO
OBJECTIVES: To describe the experience of home antibiotic infusion therapy using elastomeric infusion pumps, administered to patients admitted to the Home Hospitalization Unit of a tertiary hospital for three years and to analyse clinical evolution and mortality. METHOD: Retrospective observational study. The medical history of the patients included in the study was reviewed. Information was obtained on personal history, antimicrobial therapy received and clinical evolution. Statistical analysis was performed using SPSS® 19 software. RESULTS: Eighty-one patients were included, 61.7% men, with a mean age of 73.5 ± 17.5 years. The most frequent comorbidities were diabetes mellitus (30.9%) and chronic kidney disease (28.4%). Patients received a mean of 11.9 ± 8.5 days of antibiotic treatment in an elastomeric infusion pump. The main focus of infection was respiratory (27.2%), followed by bacteremia (16%) and skin and soft tissue infections (12.3%). Of the infections, 65.4% were monomicrobial, with Pseudomonas aeruginosa being the main microorganism involved (39.6%). The most commonly used antimicrobial was piperacillin/tazobactam (33.3%). The clinical course was good in 85.2% of the patients, but the mortality rate in the 30 days following the end of treatment was 24.7%. In the univariate analysis, a history of neoplasia in the last 5 years (p = 0.01) and having received fewer days of antibiotic therapy prior to the start of outpatient antimicrobial therapy in infusion pump (p = 0.04) were associated with worse clinical outcome. Age over 80 years was associated with better outcome (p = 0.03). The diagnosis of heart failure was associated with higher mortality (p = 0.026) and patients from surgical services, with lower mortality (p = 0.047). In the multivariate analysis, the presence of neoplasia was associated with unfavorable evolution (p = 0.012) and heart failure with higher mortality (p = 0.027). CONCLUSIONS: Outpatient antimicrobial therapy in elastomeric infusion pumps is an alternative in patients requiring prolonged intravenous treatment, and age is not a conditioning factor for inclusion in these programs. However, the presence of certain comorbidities can negatively affect the clinical course and mortality of patients.
RESUMO
Fabry disease is an X-linked lysosomal storage disorder caused by inherited deficiency of the enzyme α-galactosidase A. Enzyme replacement treatment using agalsidase alfa significantly reduces pain, improves cardiac function and quality of life, and slows renal deterioration. Nevertheless, it is a life-long treatment which requires regular intravenous infusions and entails a great burden for patients. Our objective was to evaluate retrospectively the safety and tolerability of the home infusion of agalsidase alfa in patients with Fabry disease in Argentina. We evaluated all the patients with Fabry disease who received home infusion with agalsidase alfa 0.2 mg/kg between January 2005 and June 2011. The program included 87 patients; 51 males (mean age: 30 years) and 36 females (mean age: 34 years). A total of 5229 infusions (mean: 59 per patient; range: 1-150) were administered. A total of 5 adverse reactions were seen in 5 patients (5.7% of patients and 0.9% of the total number of infusions). All were mild in severity and resolved by reducing the rate of infusion and by using antihistaminics. All these 5 patients were positive for IgG antibodies, but none of them presented IgE antibodies and none suffered an anaphylactic shock. In our group 18 patients were switched from agalsidase beta to agalsidase alfa without complications. Home infusion with agalsidase alfa is safe, well tolerated and is associated to high compliance.
La enfermedad de Fabry es un trastorno de almacenamiento lisosomal hereditario ligado al cromosoma X ocasionado por el déficit de la enzima alfa galactosidasa A. La terapia de reemplazo enzimático utilizando agalsidasa alfa reduce significativamente el dolor, mejora la función cardíaca y la calidad de vida y enlentece el deterioro renal. Sin embargo, es un tratamiento de por vida que requiere infusiones intravenosas regulares y supone una gran carga para los pacientes. Nuestro objetivo fue evaluar retrospectivamente la tolerabilidad y la seguridad del procedimiento de infusión domiciliaria de agalsidasa alfa en pacientes con enfermedad de Fabry en Argentina. Evaluamos a todos los pacientes con enfermedad de Fabry que recibieron infusiones domiciliarias de 0.2 mg/kg de agalsidasa alfa entre enero del 2005 y junio del 2011. El programa incluyó 87 pacientes; 51 hombres (edad media: 30 años) y 36 mujeres (edad media: 34 años). Se administraron un total de 5229 infusiones (media: 59 por paciente; rango: 1-50). Se observaron un total de 5 reacciones adversas en 5 pacientes (5.7% de los pacientes y 0.9 % del número total de infusiones). Todas fueron de gravedad leve y se resolvieron reduciendo la velocidad de la infusión o usando antihistamínicos. Los 5 pacientes fueron positivos para anticuerpos IgG, pero ninguno presentó anticuerpos IgE o sufrió un shock anafiláctico. En nuestro grupo, 18 pacientes fueron cambiados de agalsidasa beta a agalsidasa alfa sin complicaciones. La infusión domiciliaria de agalsidasa alfa es segura, bien tolerada y logra una alta adherencia al tratamiento.
Assuntos
Adolescente , Adulto , Idoso , Criança , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem , Terapia de Reposição de Enzimas/métodos , Doença de Fabry/tratamento farmacológico , Terapia por Infusões no Domicílio , alfa-Galactosidase/uso terapêutico , Argentina , Terapia por Infusões no Domicílio/efeitos adversos , Infusões Intravenosas , Isoenzimas/uso terapêutico , Estudos Retrospectivos , Resultado do TratamentoRESUMO
Fabry disease is an X-linked lysosomal storage disorder caused by inherited deficiency of the enzyme α-galactosidase A. Enzyme replacement treatment using agalsidase alfa significantly reduces pain, improves cardiac function and quality of life, and slows renal deterioration. Nevertheless, it is a life-long treatment which requires regular intravenous infusions and entails a great burden for patients. Our objective was to evaluate retrospectively the safety and tolerability of the home infusion of agalsidase alfa in patients with Fabry disease in Argentina. We evaluated all the patients with Fabry disease who received home infusion with agalsidase alfa 0.2 mg/kg between January 2005 and June 2011. The program included 87 patients; 51 males (mean age: 30 years) and 36 females (mean age: 34 years). A total of 5229 infusions (mean: 59 per patient; range: 1-150) were administered. A total of 5 adverse reactions were seen in 5 patients (5.7% of patients and 0.9% of the total number of infusions). All were mild in severity and resolved by reducing the rate of infusion and by using antihistaminics. All these 5 patients were positive for IgG antibodies, but none of them presented IgE antibodies and none suffered an anaphylactic shock. In our group 18 patients were switched from agalsidase beta to agalsidase alfa without complications. Home infusion with agalsidase alfa is safe, well tolerated and is associated to high compliance.(AU)
La enfermedad de Fabry es un trastorno de almacenamiento lisosomal hereditario ligado al cromosoma X ocasionado por el déficit de la enzima alfa galactosidasa A. La terapia de reemplazo enzimático utilizando agalsidasa alfa reduce significativamente el dolor, mejora la función cardíaca y la calidad de vida y enlentece el deterioro renal. Sin embargo, es un tratamiento de por vida que requiere infusiones intravenosas regulares y supone una gran carga para los pacientes. Nuestro objetivo fue evaluar retrospectivamente la tolerabilidad y la seguridad del procedimiento de infusión domiciliaria de agalsidasa alfa en pacientes con enfermedad de Fabry en Argentina. Evaluamos a todos los pacientes con enfermedad de Fabry que recibieron infusiones domiciliarias de 0.2 mg/kg de agalsidasa alfa entre enero del 2005 y junio del 2011. El programa incluyó 87 pacientes; 51 hombres (edad media: 30 años) y 36 mujeres (edad media: 34 años). Se administraron un total de 5229 infusiones (media: 59 por paciente; rango: 1-50). Se observaron un total de 5 reacciones adversas en 5 pacientes (5.7% de los pacientes y 0.9 % del número total de infusiones). Todas fueron de gravedad leve y se resolvieron reduciendo la velocidad de la infusión o usando antihistamínicos. Los 5 pacientes fueron positivos para anticuerpos IgG, pero ninguno presentó anticuerpos IgE o sufrió un shock anafiláctico. En nuestro grupo, 18 pacientes fueron cambiados de agalsidasa beta a agalsidasa alfa sin complicaciones. La infusión domiciliaria de agalsidasa alfa es segura, bien tolerada y logra una alta adherencia al tratamiento.(AU)
