Assuntos
Bronquiolite Viral/complicações , Sons Respiratórios/etiologia , Infecções por Vírus Respiratório Sincicial/complicações , Antivirais/uso terapêutico , Bronquiolite Viral/diagnóstico , Bronquiolite Viral/tratamento farmacológico , Criança , Pré-Escolar , Feminino , Seguimentos , Humanos , Lactente , Masculino , Recidiva , Sons Respiratórios/fisiopatologia , Infecções por Vírus Respiratório Sincicial/diagnóstico , Infecções por Vírus Respiratório Sincicial/tratamento farmacológico , Medição de Risco , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
OBJECTIVES: To evaluate the safety, tolerance, and efficacy of palivizumab in children with hemodynamically significant congenital heart disease (CHD). STUDY DESIGN: A randomized, double-blind, placebo-controlled trial included 1287 children with CHD randomly assigned 1:1 to receive 5 monthly intramuscular injections of 15 mg/kg palivizumab or placebo. Children were followed for 150 days. The primary efficacy end point was antigen-confirmed respiratory syncytial virus (RSV) hospitalization. RESULTS: Palivizumab recipients had a 45% relative reduction in RSV hospitalizations (P=.003), a 56% reduction in total days of RSV hospitalization per 100 children (P=.003), and a 73% reduction in total RSV hospital days with increased supplemental oxygen per 100 children (P=.014). Adverse events were similar in the treatment groups; no child had drug discontinued for a related adverse event. Serious adverse events occurred in 55.4% of palivizumab recipients and 63.1% of placebo recipients (P<.005); none were related to palivizumab. Twenty-one children (3.3%) in the palivizumab group and 27 (4.2%) in the placebo group died; no deaths were attributed to palivizumab. The rates of cardiac surgeries performed earlier than planned were similar in the treatment groups. CONCLUSIONS: Monthly palivizumab (15 mg/kg IM) was safe, well-tolerated, and effective for prophylaxis of serious RSV disease in young children with hemodynamically significant CHD.
Assuntos
Anticorpos Monoclonais/uso terapêutico , Antivirais/uso terapêutico , Cardiopatias Congênitas/epidemiologia , Hospitalização/estatística & dados numéricos , Infecções por Vírus Respiratório Sincicial/epidemiologia , Infecções por Vírus Respiratório Sincicial/prevenção & controle , Anticorpos Monoclonais Humanizados , Comorbidade , Método Duplo-Cego , Cardiopatias Congênitas/cirurgia , Humanos , Palivizumab , Respiração Artificial , Infecções por Vírus Respiratório Sincicial/terapia , Fatores de RiscoRESUMO
OBJECTIVES: To assess the prevalence of superantigen secreting bacteria in children with acute Kawasaki disease (KD) relative to control patients. STUDY DESIGN: Bacterial cultures were obtained in a blinded fashion from the throat, rectum, and groin of 45 patients with untreated acute KD and 37 febrile control patients from 6 centers in the United States. Cultures were processed for the presence of superantigen-producing bacteria at a central laboratory. RESULTS: Staphylococci or streptococci that produced superantigens (TSST-1, SEB, SEC, SPEB, SPEC) were isolated from 25 of 45 patients with KD (56%) as compared with 13 of 37 (35%) control patients (P =.078). Because SEB- and SEC-producing Staphylococcus aureus have not been associated with KD and because they do not induce a Vbeta2+ T-lymphocyte response, we analyzed the difference between groups relative to superantigens TSST-1 or SPEB/SPEC production. TSST-1 secreting S aureus or SPEB/SPEC producing group A streptococci were isolated from 20 of 45 (44%) patients with KD compared with 7 of 37 (19%) control patients (P =.019). CONCLUSIONS: The overall isolation rates of superantigen (TSST-1, SPEB, SPEC, SEB, SEC) producing bacteria between patients with KD and febrile control patients were not statistically significant. However, future studies should further examine the potential role of Vbeta2-stimulatory superantigens (TSST-1 and SPEB/SPEC) in KD.