Abstract

PAGES RUBIO, Circe; CALDERIN MARIN, Osaida  and  MORALES MENENDEZ, María. Surveillance of the effectiveness and safety of the VALERGEN vaccines in the treatment of asthma. AMC [online]. 2016, vol.20, n.6, pp. 636-647. ISSN 1025-0255.

Background: immunotherapy is the sole therapeutic strategy used to change the direction of physiopathology of allergic illnesses, hence the importance of this study, its application, the possible adverse reactions and its effectiveness in these conditions. Objective: to evaluate the effectiveness and safety of the VALERGEN vaccines in the treatment of asthma. Methods: an observational study of cohort was carried out in patients with diagnosis of mild to moderate persistent and intermittent asthma on which the administration of the VALERGEN vaccines were indicated by sublingual route or subcutaneously. An active prospective approach of the patients with asthma was used and the method of pharmacosurveillance monitoring of adverse events in a cohort was established. A sample of 100 patients fulfilling the selection criteria was conformed. The data were gathered through questionnaires. The analysis of data was done using descriptive and inferential statistics. The prosecution of information was carried out by means of the statistical package SPSS version 15.0. The obtained results were illustrated in charts and graphics. Results: a prevalence of patient with decreased asthma symptoms was found and also the need for medication with the use of immunotherapy, this result that showed a high statistical significance (p=0,000). The adverse events presented more often were, the weal >5cm, erythema,  rhinitis and the rhinitis association and asthma, these prevailed in the ages from 5 to 9 years, feminine sex, subcutaneous route, with the mixture of Dermatophagoides pteronyssinus and Blomia tropicalis (VALERGEN DP + VALERGEN BT) and with concentration of 20 000 UB/ml. Conclusion: immunotherapy with VALERGEN vaccines provides a positive clinical evolution in the majority of the patients, with a low rate of adverse events which confirms its effectiveness and safety in the treatment of asthma.

Keywords : PHARMACOVIGILANCE; DESENSITIZATION, IMMUNOLOGIC; ASTHMA [therapy]; CHILD; COHORT STUDIES.

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