[Safety analysis of dust mite allergen for diagnosis and immunotherapy of asthma and rhinitis]

Abstract

Aim: To make a retrieval investigation of safety in using Dermatophagoides farinae extract in diagnosis and immunotherapy with patients of asthma and rhinitis.

Methods: A questionnaire evaluation of the safety use of D. farinae extract (SMU-Df) during diagnosis and immunotherapy of patients from 1974 to 1995 was carried out.

Results: A total of 8,46,342 injections were statistically analysed, among whom 142 systemic adverse reactions occurred involving urticaria 0.82@10000, severe attack of asthma 0.77@10000, anaphylactic shock 0.07@10000 (CL = 1.4-12.0/million), and angioedma 0.02@10000. The time of onset of systemic reactions of immediate type was < 30 min in 32 cases-times, and 1 h and 2 h in 6 cases-times; the time to onset of late response type was 3 h-48 h in 23 cases-times with highest incidence of severe asthmatic attacks. The systemic reactions occurred in 18 subjects during skin test, in 96 cases-times during increasing dose phase, and in 14 cases-times during. Among them 6 cases were of anaphylactic shock, and none of it after emergency treatment. The major cause of manifestation of systemic reactions for 41 cases after immunotherapy with SMU-Df extract was due to over dosage errors.

Conclusion: The application of SMU-Df extract in skin test and immunotherapy of asthma and rhinitis sensitive to mite for the past 22 years in this country indicated that the efficacy and safety have been high.