Evaluation of paediatric tolerance to an extract of Alternaria alternata under two treatment regimes. A multicentre study.
In order to evaluate the efficacy and safety of an extract of Alternaria alternata in a paediatric population, a two phase study plan has been elaborated that in the first place consists of a retrospective analysis of tolerance under the standard treatment regimes used by the clinical groups involved. This was achieved by analysing the records of 94 patients that have been treated with this extract, these being consecutive patients included at 7 clinics over a period of 6 months. Two regimes were used: a conventional short regime of 7 doses and a cluster regime. Under neither of these two regimes were any serious reactions registered. The percentage of local reactions was significantly greater using the short conventional regime than with the cluster regime (1.9% and 0.4% respectively, p = .035). In contrast, no significant differences were observed with respect to the systemic reactions (0.5% and 1.2%), these percentages also being similar to those registered with other extracts in which identical regimes have been used. In conclusion, we can confirm that a very satisfactory tolerance profile was observed, with the advantage that through using shorter regimes than the conventional regime of 13 doses, a considerable saving is made both in the number of visits and the doses necessary to reach the maintenance dose.
Martínez-Cañavate
A
A
Hospital Virgen de las Nieves, Granada, Spain.
Eseverri
J L
JL
Ródenas
R
R
Tabar
A I
AI
Gardee
J
J
Torres
J
J
Boné
J
J
Pedemonte
C
C
D000293:Adolescent; D000485:Allergens / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology; D000528:Alternaria / Q000276:immunology*; D001249:Asthma / Q000209:etiology / Q000628:therapy; D002648:Child; D002675:Child, Preschool; D003371:Cough / Q000209:etiology; D003888:Desensitization, Immunologic / Q000009:adverse effects / Q000379:methods*; D004334:Drug Administration Schedule; D004485:Eczema / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D012189:Retrospective Studies; D012221:Rhinitis, Allergic, Perennial / Q000628:therapy; D014020:Tissue Extracts / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology; D014581:Urticaria / Q000209:etiology
D000485:Allergens; D014020:Tissue Extracts