Evaluation of safety and consistency of inhaled allergen extracts in the diagnosis of allergic diseases in children / 中华实用儿科临床杂志

ABSTRACT

Objective:To investigate the safety and consistency of domestic inhaled allergen extracts in the diagnosis of allergic diseases in children.Methods:Nine thousand five hundred and sixty-three children diagnosed with allergic diseases from September 2018 to June 2020 in Children′s Hospital Affiliated to Capital Institute of Pedia-trics were selected in this study, and all of them were subjected to skin prick test(SPT), and 415 of them were subjected to serum specific IgE (sIgE) test at the same time.The adverse events during SPT were recorded and the consistency of the results between SPT and sIgE test was analyzed.Results:There were 14 cases with adverse events in 9 563 patients, and the overall incidence was 0.15%.The incidence of adverse events was 0.07% (2/2 581 cases) in the 1-5 years old group, 0.19% (12/6 197 cases) in the 6-11 years old and 0 in the 12-17 years old group.The severity of all these events was grade Ⅰ.Out of the 14 cases with adverse events, only 1 case was considered to be related to allergen preparations, with the incidence being 0.01% (1/9 563 cases). The Kappa index showed that the results of dermatophagoides pteronyssinus, dermatophagoides farinae, alternaria and artemisia measured by SPT and sIgE were almost the same.There was high consistency between tree pollens and ragweed ( P<0.01), and moderate consistency between aspergillus fumigatus ( P<0.01). When the results of sIgE were used as the diagnostic criteria, the Youden index for the results of SPT ranged from 0.76 to 0.89, with aspergillus fumigatus (0.76) and tree pollens mixture (0.79) as the lowest.The positive likelihood ratio for most of the inhaled allergens was more than 10 except for tree pollens mixture (7.12) and dermatophagoides farinae (9.10). The negative likelihood ratio for most of the inhaled allergens was less than or equal to 0.1 except for aspergillus fumigatus (0.19). Conclusions:The domestic inhaled allergen extracts had high safety in the clinical application of SPT, and their results of SPT had good consistency with those of serum sIgE, which was conducive to the diagnosis and evaluation of allergic diseases in children.