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

Abstract

Objective: To assess the possibility of using a drug solution of Acarizax containing Derm house dust allergens. pteronyssinus and Derm. farinae in equal amounts - 12 SQ-HDM, in order to conduct skin prick tests to confirm the sensitization of patients to ODP.Methods: Skin prick tests with dilutions 1 tablet per 2.5 and 5 ml diluting liquid of the study drug with positive and negative controls. Statistical data processing was carried out using the Statistica 13.3 or IBM SPSS 17.0 software package. To analyze efficacy and safety data, standard parametric tests were used: Student's t-test for dependent/independent samples, analysis of variance (ANOVA) for repeated measurements, Mann-Whitney U-test, Shapiro-Wilk test. The analysis of AEs was planned to be based on an estimate of the frequency of AEs/serious AEs.Results: The correlation between the total level of specific IgE to tick allergens Derm was assessed. pteronyssinus and Derm. farinae measured at screening and papule size 20 minutes after application of the drug at a dilution of 1 tablet per 2.5 ml and 5 ml of diluting liquid - the correlation coefficient (r) in both groups (general) was 0.735 (high correlation), and 0.762 (high correlation) respectively. The result is statistically significant (p0.05) in both groups. A clinical trial has shown that the drug Acarizax, containing house dust allergens Derm. pteronyssinus and Derm.s farinae in equal amounts - 12 SQ-HDM, when used for the purpose of skin prick tests to confirm the sensitization of patients to ODP, is a safe and informative method.Conclusions: In order to conduct skin prick tests to confirm the sensitization of patients to ODP, the study drug can be used in a larger dilution - 1 tablet per 5 ml of diluting liquid. Acarizax medicinal product containing house dust allergens Derm. pteronyssinus and Derm. farinae in equal amounts - 12 SQ-HDM, when used for skin prick tests, is informative and well tolerated by patients.