Short ribosomal prophylaxis in the prevention of clinical recurrences of chronic otitis media in children.
The aim of this study was to compare the efficacy and the safety of a short oral ribosomal immunotherapy (Immucytal) in the prevention of chronic otitis media in children. Seventy-two patients were enrolled in this study, 41 males and 31 females, aged between 6 and 14 years, with an history of recurrent otitis media. Patients were randomised to receive Immucytal (group A) or placebo (group B) according to the following protocol: one tablet daily in the morning 8 days per month for three consecutive months. Immucytal and placebo were identical in shape and size, in order to maintain double-blind conditions. The efficacy parameters were (evaluated before, at the end and 6 months after the beginning of the therapy): clinical score; changes in immunological parameters; patient's parents assessment of symptoms on a scale from 0 (much worse) to 4 (much improved) and hearing tests. Patients of group A, had an improvement of clinical items measured, serum concentrations of immunoglobulins, subjective patient's parents assessment of symptoms and hearing tests. For all evaluations, a significant difference between treatment groups was found. Using this dosage and posology (shorter than others) the beneficial effects of Immucytal were maintained until the end of the 6-month study period.
Mora
Renz
R
ENT Department, University of Genoa, Via dei Mille 11/9, Genoa, 16147, Italy. renzomora@libero.it
Renzo
Mora
M
Ralli
Giovanni
G
Giovanni
Ralli
R
Passali
Francesco Mario
FM
Maria
Passali Francesco
PF
Crippa
Barbara
B
Barbara
Crippa
C
Ottoboni
Stefano
S
Stefano
Ottoboni
O
Mora
Francesco
F
Francesco
Mora
M
Barbieri
Marco
M
Marco
Barbieri
B
D000158:Acoustic Impedance Tests; D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000627:therapeutic use*; D000293:Adolescent; D000942:Antigens, Bacterial / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006309:Hearing / Q000187:drug effects; D006320:Hearing Tests; D006801:Humans; D007136:Immunoglobulins / Q000032:analysis; D007167:Immunotherapy; D008297:Male; D010034:Otitis Media with Effusion / Q000276:immunology / Q000517:prevention & control*; D012270:Ribosomes / Q000276:immunology*; D055502:Secondary Prevention; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D000942:Antigens, Bacterial; D007136:Immunoglobulins; C034206:Ribomunyl