title: [Standardizaron of the biological potency of allergenic extracts from Dermatophagoides pteronyssinus for immunotherapy].
abstract: BACKGROUND
  Allergic rhinitis and asthma are the more frequent allergic diseases. Dermatophagoides pteronyssinus is one of the more clinically relevant causes of allergic diseases.
  
  
  OBJECTIVE
  To standardize the biological potency Allergenic Bioequivalent Units (BAU) of Dermatophagoides pteronyssinus allergen extracts of three national laboratories.
  
  
  METHODS
  This experimental, prospective, transversal, quantitative study included patients allergic to house dust mites. According to the FDA protocol, allergenic extracts of Dermatophagoides pteronyssinus from three Mexican manufacturers, were injected intradermally in threefold dilutions, until get an midpoint orthogonal diameters 50 mm erythema sum. Statistical analysis was done using logistic regression, one-way analysis of variance and Bonferroni test.
  
  
  RESULTS
  We included 20 adult patients, 11 women and 9 men, aged between 16 and 45 years. Four patients had allergic asthma and rhinitis and 16 only had allergic rhinitis. There were no systemic anaphylactic reactions. Correlation coefficients of linear regression of the dose/response were to Allerstand r=0.55, Allergomex r=0.54 and Allerquim r=0.57(p=0.001). Dilutions calculated for 100,000 BAU/ml for each extract were Allerstand 1:26295, Allergomex 1:26341 and Allerquim 1:73993. The protein concentration (mcg/mL) was: Allergomex: 63, Allerquim 65, Allerstand 154.
  
  
  CONCLUSIONS
  It was established the biological potency for each tested extract. We have found significant differences in the biological equivalence among the extracts from the three manufacturers. The procedure showed an adequate safety profile.
authors.affiliation: Servicio de Alergia e Inmunología Clínica, Hospital de Especialidades Dr. Antonio Fraga Mouret, UMAE, Centro Médico La Raza, IMSS, México D.F. mbecer5@gmail.com.
authors.forename: Cristina
authors.initials: C
authors.lastname: Moctezuma-Trejo
authors.forename: Martín
authors.initials: M
authors.lastname: Becerril-Ángeles
mesh_terms: D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000276:immunology* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000818:Animals; D001688:Biological Products / Q000276:immunology* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D003430:Cross-Sectional Studies; D040002:Dermatophagoides pteronyssinus / Q000276:immunology*; D005260:Female; D006801:Humans; D007167:Immunotherapy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D000485:Allergens; D001688:Biological Products