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  • Title: Effects of oral bacterial immunotherapy in children with atopic eczema/dermatitis syndrome : a pilot study.
    Author: Brunetti L, Francavilla R, Tesse R, Fiermonte P, Dambra P, Massagli M, Loria MP, Armenio L.
    Journal: BioDrugs; 2005; 19(6):393-9. PubMed ID: 16392891.
    Abstract:
    BACKGROUND: Atopic eczema/dermatitis syndrome (AEDS) is a chronic inflammatory skin disease, affecting 10-20% of children and 1-3% of adults. The purpose of this pilot study was to assess the clinical and anti-inflammatory effect of bacterial and ribosomal immunotherapy with Immucytal (Pierre Fabre Médicament, France) in children with AEDS. METHODS: Seventeen children with allergic and non-allergic forms of AEDS (AAEDS and NAAEDS, respectively), graded moderate to severe (Severity Scoring of Atopic Dermatitis [SCORAD] index of >25), received ribosomal immunotherapy (Immucytal) once daily according to the standard treatment regimen (4 consecutive days a week for 3 weeks, and then 4 consecutive days a month for 4 months). We assessed the clinical status of AEDS using the SCORAD index at baseline, and after 8 and 20 weeks of treatment. Furthermore, peripheral blood from patients was examined for the frequencies of CD4+ cells expressing interferon (IFN)-gamma and interleukin (IL)-4 using flow cytometry. RESULTS: There was a progressive and significant clinical improvement of AEDS, confirmed by a reduction of the SCORAD index over time in both AEDS forms (p < 0.01). Pooled data from the two groups showed that the mean baseline index of 43 was reduced to 17 after treatment. Overall, these data indicate a marked improvement in total clinical severity of AEDS (-62%). Flow cytometry analysis showed that frequencies of the two CD4+ T cell subsets did not differ significantly from the beginning to the end of the study in both forms of AEDS. However, the percentage of CD4+ cells expressing IL-4 in children with AAEDS tended to decrease by the end of treatment with ribosomal immunotherapy. Clinical and laboratory data confirmed that immunotherapy was well tolerated. CONCLUSIONS: The results of this pilot investigation suggest that ribosomal immunotherapy may be beneficial in the management of AEDS in children, and that this could be at least partially explained by a role in restoring the type 2 helper-T cell imbalance seen in allergic patients. Placebo-controlled, randomized clinical trials are recommended in order to confirm these findings.
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