RESUMO
OBJECTIVES: We aimed to determine objectively the effect of the passive smoking on otitis media with effusion (OME) and recurrent otitis media (ROM) by using the method of cotinine urinalysis. STUDY DESIGN: We designed a prospective case-control study with follow-up of the case group for 1 year after insertion of tympanostomy tubes to evaluate postoperative complications such as otorrhea and early extrusion (<6 months), in case a significant risk factor was found. METHODS: One hundred fourteen children between 3 and 8 years of age requiring tympanostomy tubes because of OME and ROM were chosen and compared with 40 age-matched children. Exposure to environmental tobacco smoke was assessed by cotinine urinalysis, which was performed by means of the radioimmunoassay method. RESULTS: In this study, 73.7% (84 of 114) of the children in the case group and 55.0% (22 of 40) of the children in the control group were found to be "exposed" (P = .0461). This difference was statistically significant. Comparing the cotinine urinalysis results with parental smoking histories, 23.1% (9 of 39) of the children without parental smoking histories were "exposed" to tobacco smoke versus 84.3% (97 of 115) of the children with parental smoking histories (at least one person smoking). CONCLUSIONS: Our results indicate that sidestream smoking increases the risk of OME and ROM. Legal regulations and guidelines must be established to protect children from passive smoking. Because cotinine urinalysis is a noninvasive and reliable method for the determination of passive smoking, it can be used for that purpose.
Assuntos
Cotinina/urina , Otite Média com Derrame/etiologia , Otite Média/etiologia , Poluição por Fumaça de Tabaco/efeitos adversos , Estudos de Casos e Controles , Distribuição de Qui-Quadrado , Criança , Pré-Escolar , Intervalos de Confiança , Exposição Ambiental , Falha de Equipamento , Feminino , Seguimentos , Humanos , Masculino , Ventilação da Orelha Média/efeitos adversos , Otite Média/cirurgia , Otite Média/urina , Otite Média com Derrame/cirurgia , Otite Média com Derrame/urina , Pais , Estudos Prospectivos , Recidiva , Reprodutibilidade dos Testes , Fatores de Risco , Estatísticas não ParamétricasRESUMO
BACKGROUND: The aim of this explorative phase II study was to evaluate the activity and safety of lapatinib in combination with intravenous vinorelbine in women with HER2 positive metastatic or recurrent breast cancer. METHODS: Twenty-nine patients were enrolled. The primary objectives were response and clinical benefit (CB) rates, secondary objectives were toxicity, response duration and progression free survival. Patients received 1250 mg oral lapatinib continuously once daily and intravenous vinorelbine 20-25 mg/m(2) on days 1 and 8, every 3 weeks. RESULTS: Although 25 patients were evaluable for response, according to intend to treat analysis of 28 patients; 14% had confirmed partial response (PR) and 36% had stable disease more than 24 weeks with a CB rate of 50%. Sixty four percent of the patients suffered from grade 3-4 hematologic and 18% from grade 3 extra-hematologic toxicities. CONCLUSION: The results of this trial provide evidence to further investigate the potential of this combination for patients unsuitable for trastuzumab or who become refractory to trastuzumab.