[Multicenter drug surveillance of sublingual immunotherapy in allergic patients].
A study of pharmacovigilance has been performed in 522 patients suffering from allergic rhinitis and/or asthma. Sensitization was due to pollens and mites in ther majority of cases. The treatment consisted in biologically standardized glycerinated allergenic extracts for specific sublingual immunotherapy (SLIT) and, major allergens were also quantified, depending on the allergenic composition. The aims of the study were to assay the effect of the SLIT in a short-and-medium-term course and to know the adverse reactions most frequently appearing, as well as the unexpected side effects that are only possible to know through the study of a numerous sample of patients. We also evaluated the factors that can modify the tolerance of the treatment, such as the onset of patient's disease and its severity. All the patients had a clinical history of, at least, two years of evolution and positive skin-prick test to the allergen/s cause of their atopic disorder. Exclusion criteria were immunotherapy in the last two years, pregnancy and those situations in which the immunotherapy is contraindicated according to the EAACI requirements. In order to carry out the daily record of the SLIT as well as the possible appearance of symptoms, two diaries were given to each patient. Tolerance was evaluated by the physician at the end of the build-up phase (3 months) and when the maintenance phase finished (5 months later). Total administered doses were 44.021, the final number of patients who registered any adverse reaction in relation with SLIT was 41 (7.9%), with a number of 67 adverse reactions that means a 0.15% over the total administered doses.(ABSTRACT TRUNCATED AT 250 WORDS)
Almagro
E
E
Departamento Médico, Alergia e Inmunología, Abelló, S.A. Madrid, España.
Asensio
O
O
Bartolomé
J M
JM
Bosque
M
M
de la Hoz
B
B
Dolz
I
I
Elorza
J
J
Ferreiro
M
M
García
J M
JM
Losada
E
E
D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000818:Animals; D002648:Child; D003888:Desensitization, Immunologic / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008925:Mites / Q000276:immunology; D011058:Pollen / Q000276:immunology; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D011537:Pruritus / Q000139:chemically induced; D012130:Respiratory Hypersensitivity / Q000139:chemically induced / Q000628:therapy*
D000485:Allergens
Estudio multicéntrico de farmacovigilancia de inmunoterapia sublingual en pacientes alérgicos.