Tablet-lyophilizate containing a mixture of house dust mites usage for skin prick testing to confirm house dust mites sensitization

Abstract

BACKGROUND: Since 2021, the production of water-salt allergens for skin allergy tests with household allergens has been suspended, which has led to the lack of an objective opportunity for skin prick tests in medical and preventive institutions in the Russian Federation. Quantitative determination of allergen-specific immunoglobulin class E in the blood serum by the ImmunoCAP method is currently difficult because of the lack of supplies in the laboratory. AIMS: To assess the possibility of using a drug solution of a lyophilizate mixture of house dust mites (Acarisax) containing house dust allergens Dermatophagoides pteronyssinus and Dermatophagoides farinae in equal amounts 12 SQ-HDM for the skin hood tests to confirm the sensitization of patients with mites of home dusts. MATERIALS AND METHODS: Skin prick tests were conducted with dilutions of one tablet per 2.5 and 5 mL of diluting liquid of the study drug with positive and negative controls. Statistical analysis was conducted using Statistica 13.3 or IBM SPSS 17.0. To analyze efficacy and safety, standard parametric tests were used: Students t-test for dependent/independent samples, analysis of variance for repeated measurements, MannWhitney U-test, and ShapiroWilk test. The analysis of AEs was based on an estimate of the frequency of undesirable phenomena/serious undesirable phenomena. RESULTS: The correlation was estimated between the total level of specific IgE to tick-borne allergens D. pteronyssinus and D. farinae measured during screening and the papule size 20 min after applying the drug in breeding with one tablet per 2.5 mL and 5 mL of a diluting liquid. The correlation coefficients (R) in both groups (total) were 0.735 (high correlation) and 0.762 (high correlation). The result was statistically significant (p 0.05) in both groups. The clinical test showed that the lyophilizate drug, a mixture of domestic dust mites containing dermal dust allergens D. pteronyssinus and D. farinae in equal quantities 12 SQ-HDM is a safe and informative method when used in skin hood tests to confirm the sensitization of patients to domestic dust ticks. CONCLUSIONS: For skin hood tests, to confirm the sensitization of patients to domestic dust ticks, the studied drug can be used in greater dilution one tablet per 5 mL of the diluting fluid. The lyophilizate mixture of dust mites containing D. pteronyssinus and D. farinae homemade allergens 12 SQ-HDM is safe and well tolerated by patients when used in skin test tests.