RESUMO
BACKGROUND: Talaromyces marneffei infection is a major cause of human immunodeficiency virus (HIV)-related death in South and Southeast Asia. Guidelines recommend initial treatment with amphotericin B deoxycholate, but this drug has substantial side effects, a high cost, and limited availability. Itraconazole is available in oral form, is associated with fewer unacceptable side effects than amphotericin, and is widely used in place of amphotericin; however, clinical trials comparing these two treatments are lacking. METHODS: In this open-label, noninferiority trial, we randomly assigned 440 HIV-infected adults who had talaromycosis, confirmed by either microscopy or culture, to receive either intravenous amphotericin B deoxycholate (amphotericin) (219 patients), at a dose of 0.7 to 1.0 mg per kilogram of body weight per day, or itraconazole capsules (221 patients), at a dose of 600 mg per day for 3 days, followed by 400 mg per day, for 11 days; thereafter, all the patients received maintenance therapy with itraconazole. The primary outcome was all-cause mortality at week 2. Secondary outcomes included all-cause mortality at week 24, the time to clinical resolution of talaromycosis, early fungicidal activity, relapse of talaromycosis, development of the immune reconstitution inflammatory syndrome (IRIS), and the side-effect profile. RESULTS: The risk of death at week 2 was 6.5% in the amphotericin group and 7.4% in the itraconazole group (absolute risk difference, 0.9 percentage points; 95% confidence interval [CI], -3.9 to 5.6; P<0.001 for noninferiority); however, the risk of death at week 24 was 11.3% in the amphotericin group and 21.0% in the itraconazole group (absolute risk difference, 9.7 percentage points; 95% CI, 2.8 to 16.6; P=0.006). Treatment with amphotericin was associated with significantly faster clinical resolution and fungal clearance and significantly lower rates of relapse and IRIS than itraconazole. The patients who received amphotericin had significantly higher rates of infusion-related reactions, renal failure, hypokalemia, hypomagnesemia, and anemia than patients in the itraconazole group. CONCLUSIONS: Amphotericin was superior to itraconazole as initial treatment for talaromycosis with respect to 6-month mortality, clinical response, and fungicidal activity. (Funded by the Medical Research Council and others; IVAP Current Controlled Trials number, ISRCTN59144167 .).
Assuntos
Infecções Oportunistas Relacionadas com a AIDS/tratamento farmacológico , Anfotericina B/uso terapêutico , Antifúngicos/uso terapêutico , Ácido Desoxicólico/uso terapêutico , Itraconazol/uso terapêutico , Micoses/tratamento farmacológico , Talaromyces , Infecções Oportunistas Relacionadas com a AIDS/mortalidade , Administração Oral , Adulto , Anfotericina B/efeitos adversos , Antifúngicos/efeitos adversos , Creatinina/metabolismo , Ácido Desoxicólico/efeitos adversos , Combinação de Medicamentos , Feminino , Humanos , Quimioterapia de Indução/efeitos adversos , Infusões Intravenosas/efeitos adversos , Itraconazol/efeitos adversos , Masculino , Micoses/mortalidade , Talaromyces/isolamento & purificaçãoRESUMO
The study aims to examine correlations between nutrition status with different factors and dental caries of preschool children in rural areas of Vietnam. A big data based on a total of 690 children (356 boys and 334 girls), aged 2-5 years, living in Van Xuan commune, were thoroughly analyzed. Oral examinations were performed by dentists with the assistance of nursery teachers and the research team. Caries was diagnosed using criteria established by the International Caries Detection and Assessment System (ICDAS). The examined children and their parents responded to questions pertaining to dental hygiene practices. The nutrition status of preschool children was determined by the World Health Organization (WHO) standards in 2006. There are factors which have effects on the malnutrition status of children in the research. The prevalence of dental caries also contributed importantly to assess children's development. In this study, the stunting groups have a higher ratio of caries compared to the others. Children's morphology and nutritional status are associated with dental caries among the preschool children in Van Xuan commune, Vinh Tuong district, Vinh Phuc province.