RESUMO
Attending day care is associated with recurrent respiratory infections (RRIs) and asthma. Ribosomal immunotherapy may confer protection against RRIs in children. This study was designed to assess the efficacy of a ribosome-component immune modulator (RCIM) as preventive treatment of respiratory infections in socialized children aged ≤5 years, with or without a history of frequent RRI. In a multicenter, Italian, randomized, double-blind, placebo-controlled, parallel-group study, 164 socialized day care center children (mean age, 3.8 ± 1.1 years) were treated with RCIM or placebo for 6 months and followed-up for additional 6 months. Outcomes are presented for the intent-to-treat population. In socialized children with five or less RRIs (n = 95; 49 RCIM and 46 placebo, group A) the duration of the infectious episodes was significantly shorter with RCIM than with placebo (6 months, 3.7 ± 2.1 versus 4.5 ± 1.9 days, p = 0.040; 12 months, 3.6 ± 2.0 versus 4.7 ± 2.5 days, p = 0.015). The proportion of patients reporting no respiratory infectious episodes with RCIM at 6 and 12 months was also significantly larger in group A (20.4% versus 4.4% placebo; p = 0.028). No such differences were found in children with more than five RRIs in the preceding year (n = 63; 32 RCIM and 31 placebo, group B). In all children, general well-being improved significantly more under RCIM than under placebo (11.6 ± 1.8% versus 10.2 ± 1.8%; p = 0.002). No statistically significant between-treatment differences were observed for other end points. Both treatments were similarly well tolerated. Six-month treatment with RCIM effectively prevented the 12-month risk of RRIs in children <5 years old and with five or less RRIs in the preceding year.
Assuntos
Antígenos de Bactérias/uso terapêutico , Fatores Imunológicos/uso terapêutico , Infecções Respiratórias/tratamento farmacológico , Creches , Pré-Escolar , Método Duplo-Cego , Feminino , Humanos , Itália , Masculino , Prevenção Secundária , Resultado do TratamentoRESUMO
BACKGROUND: Hydrolyzed formulas (HFs) are in general well tolerated by children with cow's milk allergy (CMA), although cases of allergic reactions have been reported and residual allergenicity of HF has been demonstrated OBJECTIVE: To review the most relevant studies of the HFs for residual allergenicity, tolerance, and safety in the past 20 years. DATA SOURCES AND METHODS: MEDLINE searches for the years 1970 to 2001 using the following algorithm (hydrolysate and allergy; food intolerance/allergy; protein hydrolysate). RESULTS: The literature confirmed that although some antigenicity remains, HFs are well tolerated by children with CMA. Rice HF has proven safe when tested by double-blind, placebo-controlled food challenge in a study population of 18 children allergic both to cow's milk (CM) and soy protein. CONCLUSIONS: Absolute avoidance of CM proteins means substitution by soy-, rice-, or amino acid-based formulas. As 8 to 14% of infants allergic to CM react to soy and amino acid-based formulas are expensive, scientific societies recommend the use of formulas based on extensively hydrolyzed CM proteins as first alternatives in children with CMA. Although both soy- and rice-based HFs have now been shown to be safe for these children, further nutritional and clinical studies are needed.
Assuntos
Bovinos/imunologia , Hipersensibilidade a Leite/dietoterapia , Leite/imunologia , Hidrolisados de Proteína/uso terapêutico , Alérgenos/efeitos adversos , Alérgenos/imunologia , Animais , Criança , Pré-Escolar , Ensaios Clínicos como Assunto , Humanos , Lactente , Leite/efeitos adversos , Hipersensibilidade a Leite/imunologia , Oryza/imunologia , Hidrolisados de Proteína/efeitos adversos , Hidrolisados de Proteína/imunologia , Proteínas de Soja/imunologiaRESUMO
BACKGROUND: Allergy-like symptoms are common in young children, but the case history and physical examination cannot identify the underlying origins of overlapping symptom profiles. OBJECTIVE: To evaluate a blood test, Phadiatop Infant (Pharmacia Diagnostics AB, Uppsala, Sweden), for differentiating the capability of IgE-mediated disease in young children with recurrent wheezing, eczema, or both. METHODS: One hundred forty-seven children (mean age, 2.0 years) were consecutively referred to 2 allergy centers by their primary care physician for recurrent wheezing, eczema, or both. The allergist's clinical evaluation included medical history, physical examination, skin prick testing with inhalant and food allergens, and specific IgE determinations in blood. The accuracy of Phadiatop Infant was evaluated in a masked manner against the allergist's final diagnosis. RESULTS: Sixty-nine children had wheezing, 69 had eczema, and 9 had both symptoms. Sixty-one children were clinically diagnosed as having IgE-mediated allergy, 78 as having non-IgE-associated disease, and 8 as having an inconclusive diagnosis. Fifty-six of the 61 children with IgE-mediated allergy had positive Phadiatop Infant test results, and 64 of 78 without the condition had negative results. Sensitivity was 92% and specificity was 82%, with positive and negative predictive values of 80% and 93%, respectively. Thirteen children with a positive Phadiatop Infant test result and a negative final diagnosis were retested after 2 years; 12 of them were diagnosed as having IgE-mediated allergy using a masked evaluation. CONCLUSIONS: The Phadiatop Infant blood test discriminates between IgE- and non-IgE-mediated symptoms in children younger than 4 years.