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Clinical Trial
. 2005 Mar-Apr;33(2):100-4.
doi: 10.1157/13072921.

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

J Garde  1 , A Ferrer, V Jover, J A Pagan, C Andreu, A Abellan, R Félix, J M Milán, M Pajarón, A J Huertas, J R Lavín, F de la Torre
Affiliations
Clinical Trial

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

J Garde et al. Allergol Immunopathol (Madr). 2005 Mar-Apr.

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.

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