RESUMO
OBJECTIVE: To develop a parent-reported Pediatric Rhinosinusitis Symptom Scale (PRSS) that could be used to monitor symptoms of young children with acute sinusitis in response to therapy. STUDY DESIGN: We developed an 8-item symptom severity scale and evaluated its internal reliability, construct validity, and responsiveness in children 2-12 years of age with acute sinusitis. Parents of 258 children with acute sinusitis completed the PRSS at the time of diagnosis, as a diary at home, and at the follow-up visit at days 10-12. Based on psychometric results and additional parent feedback, we revised the scale. We evaluated the revised version in 185 children with acute sinusitis. RESULTS: Correlations between the scale and reference measures on the day of enrollment were in the expected direction and of the expected magnitude. PRSS scores at the time of presentation correlated with radiographic findings (P < .001), functional status (P < .001), and parental assessment of overall symptom severity (P < .001). Responsiveness (standardized response mean) and test-retest reliability of the revised scale were good (2.17 and 0.75, respectively). CONCLUSIONS: We have developed an outcome measure to track the symptoms of acute sinusitis. Data presented here support the use of the PRSS as a measure of change in symptom burden in clinical trials of children with acute sinusitis.
Assuntos
Avaliação de Resultados em Cuidados de Saúde/métodos , Sinusite/fisiopatologia , Doença Aguda , Criança , Pré-Escolar , Análise Fatorial , Feminino , Humanos , Avaliação de Resultados em Cuidados de Saúde/normas , Pais , Estudos Prospectivos , Reprodutibilidade dos TestesRESUMO
OBJECTIVE: We conducted a population-based pharmacokinetic study to assess blood levels and elimination of mercury after vaccination of premature infants born at > or =32 and <37 weeks of gestation and with birth weight > or =2000 but <3000 g. STUDY DESIGN: Blood, stool, and urine samples were obtained before vaccination and 12 hours to 30 days after vaccination from 72 premature newborn infants. Total mercury levels were measured by atomic absorption. RESULTS: The mean +/- standard deviation (SD) birth weight was 2.4 +/- 0.3 kg for the study population. Maximal mean +/- SD blood mercury level was 3.6 +/- 2.1 ng/mL, occurring at 1 day after vaccination; maximal mean +/- SD stool mercury level was 35.4 +/- 38.0 ng/g, occurring on day 5 after vaccination; and urine mercury levels were mostly nondetectable. The blood mercury half-life was calculated to be 6.3 (95% CI, 3.85 to 8.77) days, and mercury levels returned to prevaccination levels by day 30. CONCLUSIONS: The blood half-life of intramuscular ethyl mercury from thimerosal in vaccines given to premature infants is substantially shorter than that of oral methyl mercury in adults. Because of the differing pharmacokinetics, exposure guidelines based on oral methyl mercury in adults may not be accurate for children who receive thimerosal-containing vaccines.
Assuntos
Vacinas contra Hepatite B/química , Mercúrio/metabolismo , Conservantes Farmacêuticos/farmacocinética , Timerosal/farmacocinética , Feminino , Seguimentos , Meia-Vida , Vacinas contra Hepatite B/administração & dosagem , Humanos , Recém-Nascido de Baixo Peso , Recém-Nascido , Recém-Nascido Prematuro , Injeções Intramusculares , Masculino , Estudos ProspectivosRESUMO
OBJECTIVE: To evaluate the immunogenicity and safety of a diphtheria and tetanus toxoids, acellular pertussis, hepatitis B, and inactivated poliovirus-containing vaccine (DTaP-HepB-IPV) coadministered with pneumococcal 7-valent conjugate vaccine (PCV-7) and Haemophilus influenzae type b vaccine (Hib), with separate vaccines concurrently, or staggered (delayed) administration of PCV-7. STUDY DESIGN: At 2, 4, and 6 months of age, infants received either DTaP-HepB-IPV plus PCV-7 and Hib (n = 199), separate vaccines (n = 188), or DTaP-HepB-IPV plus Hib with PCV-7 administered 2 weeks later (n = 188). Blood was drawn before and after vaccination. Parents reported symptoms for 4 days after each dose and adverse events throughout the entire study. RESULTS: Immunogenicity in the Combination Vaccine Group was noninferior to that of the Separate and Staggered Vaccine Groups with respect to seroprotective rates for diphtheria, tetanus, and poliovirus and to geometric mean concentrations for pertussis. Seroprotective rates for HepB and Hib were not different between groups. Seropositivity for PCV-7 was high in all groups. Administration of combination vaccine appeared to be associated with higher rates of irritability, fever > or = 100.4 degrees F (38.0 degrees C) and some local symptoms compared with separate vaccines (exploratory P < .05). No group differences were observed in rates of symptoms for which parents sought medical advice. CONCLUSIONS: DTaP-HepB-IPV was highly immunogenic and well tolerated when coadministered with Hib and PCV-7 at 2, 4, and 6 months of age.
Assuntos
Vacinas contra Difteria, Tétano e Coqueluche Acelular/imunologia , Vacinas contra Hepatite B/imunologia , Vacinas Pneumocócicas/imunologia , Vacina Antipólio de Vírus Inativado/imunologia , Toxoide Tetânico/imunologia , Vacinação/métodos , Cápsulas Bacterianas , Intervalos de Confiança , Vacinas contra Difteria, Tétano e Coqueluche Acelular/administração & dosagem , Feminino , Seguimentos , Vacinas Anti-Haemophilus/administração & dosagem , Vacinas Anti-Haemophilus/imunologia , Vacinas contra Hepatite B/administração & dosagem , Humanos , Imunidade/fisiologia , Esquemas de Imunização , Lactente , Masculino , Análise Multivariada , Vacinas Pneumocócicas/administração & dosagem , Vacina Antipólio de Vírus Inativado/administração & dosagem , Polissacarídeos Bacterianos/administração & dosagem , Polissacarídeos Bacterianos/imunologia , Medição de Risco , Método Simples-Cego , Toxoide Tetânico/administração & dosagem , Vacinação/efeitos adversos , Vacinas Combinadas/administração & dosagem , Vacinas Combinadas/imunologia , Vacinas Conjugadas/administração & dosagem , Vacinas Conjugadas/imunologiaRESUMO
BACKGROUND: Levofloxacin has excellent activity against common respiratory pathogens and therefore is likely to be effective in treating children with persistent or recurrent otitis media. OBJECTIVE: The objective of this study was to assess the efficacy and safety of levofloxacin treatment in the eradication of bacterial pathogens from the middle ear fluid (MEF) of children with, or at high risk for, persistent or recurrent otitis media. METHODS: An open-label multicenter trial was conducted that involved tympanocentesis at entry and selectively 3 to 5 days after starting levofloxacin (10 mg/kg twice a day for 10 days). RESULTS: : Two hundred five children (80% < or =2 years) were enrolled. One child did not have a confirmed diagnosis of acute otitis media and did not return for follow-up visits. Of the remaining 204 children, 94 (46%) had bilateral infection and 63 (31%) were receiving antimicrobials immediately before entry. One hundred five isolates of Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus. pyogenes were recovered in pure or mixed cultures. All isolates were susceptible to levofloxacin. During-treatment bacterial eradication from MEF occurred in 88% (78 of 89) of bacteriologically evaluable patients, including 90% (65 of 72) of children < or =24 months of age. Bacteria initially isolated from MEF were eradicated in 31 of 37 (84%) children infected with S. pneumoniae and in 54 of 54 (100%) children infected with H. influenzae. Overall, clinical success rate after therapy was 94% for the total study population and 92% for the bacteriologically evaluable population. Levofloxacin was well tolerated. Vomiting (4%) was the most common treatment-limiting adverse event. CONCLUSIONS: Levofloxacin was safe and effective in treating and eradicating common bacterial pathogens from MEF in children with, or at risk for, recurrent or persistent otitis media.
Assuntos
Antibacterianos/uso terapêutico , Bactérias/classificação , Bactérias/efeitos dos fármacos , Infecções Bacterianas/tratamento farmacológico , Levofloxacino , Ofloxacino/uso terapêutico , Otite Média/tratamento farmacológico , Otite Média/microbiologia , Doença Aguda , Antibacterianos/administração & dosagem , Bactérias/isolamento & purificação , Infecções Bacterianas/microbiologia , Pré-Escolar , Exsudatos e Transudatos/microbiologia , Feminino , Humanos , Lactente , Masculino , Testes de Sensibilidade Microbiana , Ofloxacino/administração & dosagem , Ofloxacino/efeitos adversos , Paracentese , Resultado do TratamentoRESUMO
BACKGROUND: Given the relatively high prevalence of recurrent and persistent acute otitis media (AOM) and the prominent etiologic role of Streptococcus pneumoniae, especially penicillin-nonsusceptible strains in children with these conditions, new alternative treatments are desirable. METHODS: Children 6 months-4 years of age with AOM considered to be at risk for recurrent or persistent infection received large dosage cefdinir 25 mg/kg oral suspension once daily for 10 days. Children were evaluated pretreatment (day 1), on therapy (days 4-6), end of therapy (days 12-14) and at follow-up (days 25-28). All children had tympanocentesis at enrollment. In culture-positive children, tympanocentesis was repeated after 3-5 days (days 4-6) unless evidence of absence of middle ear effusion was documented. RESULTS: Of 447 children enrolled, 230 were clinically and bacteriologically evaluable (74% 2 years old or younger; 57% treated for AOM in previous 3 months). Bacteriologic eradication, based on repeat tympanocentesis on days 4-6, was achieved in 74% (170 of 230) of children; 76% (201 of 266) of AOM pathogens were eradicated. Eradication of penicillin-susceptible, -intermediate and -resistant S. pneumoniae was 91% (50 of 55), 67% (18 of 27) and 43% (10 of 23), respectively (P < 0.001); eradication of H. influenzae was 72% (90 of 125). Overall clinical response at days 12-14 was 83% (76 and 82% for children with S. pneumoniae and Haemophilus influenzae, respectively). Sustained clinical response at days 25-28 was 85%. Clinical response was 83% for culture-positive children versus 96% for culture-negative children at baseline tympanocentesis (P < 0.001). CONCLUSIONS: In this study of AOM among children at risk for persistent or recurrent infection, large dose cefdinir resulted in an overall successful clinical response at end of treatment of 83%. This regimen was efficacious against penicillin-susceptible S. pneumoniae, but effectiveness was markedly decreased against nonsusceptible strains and was moderate for H. influenzae strains.
Assuntos
Anti-Infecciosos/administração & dosagem , Cefalosporinas/administração & dosagem , Otite Média com Derrame/tratamento farmacológico , Doença Aguda , Administração Oral , Anti-Infecciosos/efeitos adversos , Anti-Infecciosos/uso terapêutico , Cefdinir , Cefalosporinas/efeitos adversos , Cefalosporinas/uso terapêutico , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Testes de Sensibilidade Microbiana , Otite Média com Derrame/microbiologia , Paracentese/métodos , Resistência às Penicilinas , Infecções Pneumocócicas/tratamento farmacológico , Infecções Pneumocócicas/microbiologia , Recidiva , Fatores de Risco , Streptococcus pneumoniae/efeitos dos fármacos , Resultado do TratamentoRESUMO
OBJECTIVES: To investigate safety, efficacy, and immunogenicity of live quadrivalent rotavirus vaccine (QRV) containing human-bovine (WC3) reassortant rotavirus serotypes G1, G2, G3, and P1a. STUDY DESIGN: This was a randomized, double-blinded, placebo-controlled trial. During 1993 to 1994, at 10 US study sites, 439 healthy infants approximately 2 to 6 months of age, were enrolled to receive 3 doses of oral QRV or placebo at approximately 8-week intervals. RESULTS: The vaccine was generally well tolerated; no serious vaccine-related adverse experiences were reported. Risk differences and 95% confidence intervals suggested no differences between vaccine and placebo recipients in the incidences of fever, irritability, vomiting, or diarrhea during the 14 days after any dose. QRV was 74.6% efficacious (95% CI: 49.5%, 88.3%) in preventing rotavirus acute gastroenteritis (AGE), regardless of severity and 100% efficacious (95% CI: 43.5%, 100%) in preventing severe rotavirus AGE through one rotavirus season. Serotype G1 was identified in most infants with rotavirus AGE. A >or=3-fold rise in serum neutralizing antibody to G1 was observed in 57% (45/79) of vaccinees. A >or=3-fold rise in serum anti-rotavirus IgA and fecal anti-rotavirus IgA was observed in 88% (162/185) and 65% (104/159) of vaccinees, respectively. CONCLUSIONS: QRV was generally well tolerated, immungenic, and highly effective against rotavirus gastroenteritis.
Assuntos
Vírus Reordenados/imunologia , Infecções por Rotavirus/imunologia , Vacinas contra Rotavirus/imunologia , Rotavirus/imunologia , Animais , Anticorpos Antivirais/biossíntese , Anticorpos Antivirais/sangue , Bovinos , Método Duplo-Cego , Esquema de Medicação , Fezes/virologia , Feminino , Gastroenterite/prevenção & controle , Gastroenterite/virologia , Humanos , Imunoglobulina A/sangue , Imunoglobulina A/imunologia , Lactente , Masculino , Infecções por Rotavirus/prevenção & controle , Vacinas contra Rotavirus/efeitos adversos , Sorotipagem , Vacinas Atenuadas/imunologiaRESUMO
Objetivo: Identificamos os patógenos causadores de otite média aguda persistente e recorrente (OMA) e a eficácia clínica do cefprozil como tratamento. Modelo do estudo: Este foi um ensaio nao comparativo, aberto e multicêntrico. Crianças com idade entre seis meses a 12 anos de idade, que apresentavam sinais e sintomas de OMA e evidências de efusao no ouvido médio confirmadas por otoscopia pneumática ou timpanometria, foram submetidas à timpanocentese e ao tratamento subseqüente com o cefprozil (15 mg/Kg duas vezes ao dia) durante 10 dias. O estudo buscou recrutar particularmente os pacientes com otite média recorrente ou aqueles que nao responderam à antibioticoterapia ou profilaxia prévias. Resultados: Duzentos e sessenta e duas (99 por cento) das 265 crianças arroladas foram consideradas passíveis de avaliaçao. A idade mediana do grupo de estudo foi de um ano. Noventa e oito (37 por cento) crianças apresentavam histórico de uso prévio de antibióticos (durante um período de 30 dias). Noventa e sete (37 por cento) preencheram nossos critérios de definiçao de OMA recorrente, 48 (18 por cento), de OMA persistente e 132 (50 por cento) crianças apresentaram três ou mais episódios anteriores de otite média aguda nos 12 meses que antecederam o estudo. Oitenta e duas (31 por cento) timpanocenteses na ocasiao da inclusao nao mostraram crescimento de microorganismos, 150 (57 por cento) evidenciaram um único patógeno bacteriano e 29 (11 por cento), múltiplos patógenos bacterianos. Dos 93 isolados de Streptococcus pneumoniae no pré-tratamento, 50 (54 por cento) eram sensíveis à penicilina, 12 (13 por cento) apresentavam resistência intermediária à penicilina e 31 (33 por cento) eram resistentes a este antibiótico. Dos 75 isolados de Haemophilus influenzae no pré-tratamento, 42 (56 por cento) produziram betalactamase, bem como quatro (27 por cento) das 15 cepas de Moraxella catarrhalis. Encontrou-se resposta clínica satisfatória por patógeno em 75 por cento (70 entre 93) com S. pneumoniae, 75 por cento (56 de 75) com H. influenzae e 93 por cento (13 de 14) com M. catarrhalis; a resposta das infecçoes causadas por um único patógeno foi maior do que as de múltiplos patógenos (118 de 150 [78 por cento) e 17 de 29 [59 por cento], respectivamente; P=0,03). A resposta dos pacientes com isolados de S. pneumoniae sensíveis com resistência intermediária ou resistentes à penicilina foi...