Asunto(s)
Alérgenos/administración & dosificación , Desensibilización Inmunológica/efectos adversos , Desensibilización Inmunológica/métodos , Hipersensibilidad/terapia , Alérgenos/efectos adversos , Femenino , Humanos , Hipersensibilidad/inmunología , Modelos Logísticos , Masculino , Análisis Multivariante , Ápice del Flujo Espiratorio , Factores de RiesgoRESUMEN
BACKGROUND: Despite its clinical effectiveness, allergen immunotherapy (AIT) remains controversial because serious systemic reactions can occur during its administration. Most of the studies on the safety of AIT are retrospective and use different methods, which frequently depart from daily clinical practice. OBJECTIVE: The aim of this study was to determine risk factors for adverse reactions, especially systemic adverse reactions, produced during routine AIT administration. METHODS: We registered 5,768 consecutive doses of standardized extracts administered to 273 patients in conventional schedules, following the recommendations on safety and data collection of the European Academy of Allergology and Clinical Immunology. Of the 273 patients, 236 were asthmatics, 28 had rhinitis and 9 received immunotherapy due to Hymenoptera anaphylaxis. RESULTS: We examined 143 local reactions (2.48 % of the doses) and 145 systemic reactions (78 immediate and 67 delayed). Risk factors for developing an immediate systemic reaction were asthma severity, sensitization to molds, the most concentrated vials and a fall in peak expiratory flow of more than 15 % or an immediate systemic reaction in the previous dose. Late systemic reactions were significantly more frequent with less concentrated vials and in patients with late local reactions in the previous dose. No serious reactions were registered. CONCLUSIONS: We believe that AIT is reliable when used with strict safety protocols and administered by specialized staff. Risk factors for adverse reactions to this type of treatment can be identified and reduced by systematic data collection.
Asunto(s)
Anafilaxia/etiología , Desensibilización Inmunológica/efectos adversos , Adolescente , Adulto , Anciano , Alergia e Inmunología/organización & administración , Anafilaxia/epidemiología , Angioedema/epidemiología , Angioedema/etiología , Asma/epidemiología , Asma/etiología , Niño , Preescolar , Conjuntivitis Alérgica/epidemiología , Conjuntivitis Alérgica/etiología , Relación Dosis-Respuesta Inmunológica , Eccema/epidemiología , Eccema/etiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Rinitis Alérgica Perenne/epidemiología , Rinitis Alérgica Perenne/etiología , Factores de Riesgo , Urticaria/epidemiología , Urticaria/etiologíaAsunto(s)
Broncodilatadores/efectos adversos , Dermatitis por Contacto/etiología , Hipersensibilidad a las Drogas/etiología , Mucosa Nasal/efectos de los fármacos , Pregnenodionas/efectos adversos , Adulto , Aerosoles , Budesonida , Femenino , Humanos , Mucosa Nasal/patología , Nasofaringitis/inducido químicamente , Pregnenodionas/uso terapéutico , Rinitis/inducido químicamente , Rinitis/tratamiento farmacológico , Pruebas CutáneasRESUMEN
Background: Despite its clinical effectiveness, allergen immunotherapy (AIT) remains controversial because serious systemic reactions can occur during its administration. Most of the studies on the safety of AIT are retrospective and use different methods, which frequently depart from daily clinical practice. Objective: The aim of this study was to determine risk factors for adverse reactions, especially systemic adverse reactions, produced during routine AIT administration. Methods: We registered 5,768 consecutive doses of standardized extracts administered to 273 patients in conventional schedules, following the recommendations on safety and data collection of the European Academy of Allergology and Clinical Immunology. Of the 273 patients, 236 were asthmatics, 28 had rhinitis and 9 received immunotherapy due to Hymenoptera anaphylaxis. Results: We examined 143 local reactions (2.48 % of the doses) and 145 systemic reactions (78 immediate and 67 delayed). Risk factors for developing an immediate systemic reaction were asthma severity, sensitization to molds, the most concentrated vials and a fall in peak expiratory flow of more than 15 % or an immediate systemic reaction in the previous dose. Late systemic reactions were significantly more frequent with less concentrated vials and in patients with late local reactions in the previous dose. No serious reactions were registered. Conclusions: We believe that AIT is reliable when used with strict safety protocols and administered by specialized staff. Risk factors for adverse reactions to this type of treatment can be identified and reduced by systematic data collection (AU)
Antecedentes: La inmunoterapia con alergenos es aún controvertida para algunos grupos, a pesar de su eficacia clínica, porque puede provocar reacciones sistémicas graves durante su administración. La mayoría de estudios sobre la seguridad de la inmunoterapia con alergenos son retrospectivos y emplean diferentes metodologías, muchas veces apartados de la realidad clínica diaria. Objetivos: El ánimo de este estudio fue conocer los factores de riesgo de las reacciones adversas, especialmente sistémicas, producidas durante la administración rutinaria de inmunoterapia. Métodos: Registramos 5.768 dosis consecutivas de extractos estandarizados administrados a 273 pa- cientes con pautas convencionales, siguiendo las recomendaciones de seguridad y recogida de datos de la EAACI (European Academy of Allergology and Clinical Immunology). De todos los pacientes 236 eran asmáticos, 28 riníticos y 9 recibieron inmunoterapia por anafilaxia por Himenópteros. Resultados: Registramos 143 reacciones locales (2,48 por ciento de las dosis), y 145 reacciones sistémicas (78 inmediatas y 67 tardías). Encontramos como factores de riesgo para el desarrollo de reacciones inmediatas sistémicas: la gravedad del asma, la sensibilización a hongos, los viales mas concentrados, la caída del PEF superior al 15 por ciento en la dosis previa y la presencia de otra reacción sistémica inmediata en la dosis anterior. Las reacciones sistémicas tardías fueron significativamente mas frecuentes con los viales menos concentrados y en los pacientes con reacciones locales tardías en la dosis previa. No se produjo ninguna reacción grave. Conclusiones: Creemos que la IT es segura cuando se emplean protocolos de seguridad estrictos y es administrada por personal especializado. La recogida sistemática de datos permite conocer y reducir los factores de riesgo relacionados con las reacciones adversas a este tipo de tratamiento (AU)