Tolerance of a Salsola kali extract standardized in biological units administered by subcutaneous route. Multicenter study

ABSTRACT

Background: Sensitivity to Salsola kali is a frequent cause of allergic respiratory disease in various regions of Spain. However, there are very few articles in which this allergen has been studied. Methods and Results: In order to evaluate the tolerance of this extract, a prospective study has been performed. This study was observational, multi-centred and open, involving 88 patients with allergic respiratory disease due to sensitivity to Salsola, aged between 5 and 52 years. The administration of the extract was performed subcutaneously, through one of two treatment schedules: cluster (8 doses in 4 visits) or conventional (13 doses in 12 visits). A total of 42 adverse reactions were registered, in 26 patients (35 local reactions in 21 patients and 7 systemic reactions in 6 patients). Among the 7 systemic reactions, 4 were registered with the cluster protocol and 2 with the conventional protocol (p = 0.329). In no patients were serious adverse reactions registered. Conclusion: The subcutaneous administration of a Salsola extract is safe and well tolerated, both when administered using a conventional schedule and when using a cluster schedule

RESUMEN

Antecedentes: La sensibilización a Salsola kali es una causa frecuente de enfermedad alérgica respiratoria en varias zonas de España. Sin embargo, apenas existen publicaciones en las que se estudie este alergeno. Métodos y resultados: Para valorar la tolerancia de este extracto, se ha realizado un estudio prospectivo, observacional, multicéntrico y abierto, en el que se han incluido 88 pacientes, de edad entre 5 y 52 años, con enfermedad alérgica respiratoria por sensibilización a Salsola. La administración del extracto se ha realizado por vía subcutánea, mediante dos esquemas de tratamiento: agrupada (8 dosis en 4 visitas) o convencional (13 dosis en 12 visitas). Se han registrado un total de 42 reacciones adversas en 26 pacientes (35 locales en 21 pacientes y 7 sistémicas en 6 pacientes). De las 7 reacciones sistémicas, 4 se registraron con la pauta agrupada y 2 con la convencional (p = 0,329). No se registró ninguna reacción adversa grave. Conclusión: La administración subcutánea de un extracto de Salsola es segura y bien tolerada, tanto cuando se administra con una pauta convencional como con una pauta agrupada