Subcutaneous allergen immunotherapy for asthma: A randomized, double-blind, placebo-controlled study with a standardized Blomia tropicalis vaccine.

BACKGROUND: Sensitization to Blomia tropicalis (Bt) is very frequent in the tropics, and particularly in Cuba, being a significant cause of allergic asthma. Allergen immunotherapy (AIT) with Bt can be a therapeutic option, however, placebo-controlled clinical trials have not been reported. OBJECTIVE: To assess the therapeutic effect and safety of AIT for asthma using a standardized allergen vaccine of B. tropicalis by subcutaneous route, in allergic asthmatic patients exposed and sensitized to this mite species. METHODS: A double-blind, placebo-controlled Phase II trial was conducted in 35 adults (18 with treatment and 17 with placebo), with mild to moderate asthma, predominantly sensitized to Bt. AIT was administered subcutaneously in increasing doses from 4 to 6000 Biological Units using a locally manufactured standardized extract (BIOCEN, Cuba). Patient assessment was performed using symptom-medication score (SMS), peak expiratory flow and skin reactivity relative to Histamine as measured by skin prick test (SPT). RESULTS: The 12-month treatment achieved a significant (p < 0.001) decrease of SMS. Symptom score showed only 41% (CI: 26-61) of placebo values, whereas medication was 34.5% (22.4%-63.3%). Treatment was regarded clinically effective in 67% of patients (OR 32; 95%CI: 17 to 102). The effect size on symptoms and medication was higher than has been reported with equivalent allergen dosages of D. pteronyssinus and D. siboney in Cuban asthmatic patients. Skin reactivity to Bt was also significantly reduced (p = 0.0001), increasing 148-fold the allergen threshold to elicit a positive skin test. This desensitization effect was specific to Bt and did not modify the reactivity to Dermatophagoides. The change of specific skin reactivity was significantly (p < 0.05) correlated to clinical improvement. All adverse events were local with a frequency of 2.4% of injections. CONCLUSIONS: Subcutaneous AIT with Blomia tropicalis was effective and safe in asthmatic adults exposed and sensitized to this mite species in a tropical environment. TRIAL REGISTRATION: Cuban Public Registry of Clinical Trials: RPCEC00000026 (WHO International Clinical Trial Registry Platform ICTRP).

[Sensitivity and specificity of prick skin test with two concentrations of standardized extract of Culex quinquefasciatus in allergic children]. / Sensibilidad y especificidad de la prueba cutánea por punción con dos concentraciones del extracto estandarizado de Culex quinquefasciatus en niños alérgicos.

BACKGROUND: Diagnostic options for immune reactions to mosquito bites are limited. In Cuba, IgE-mediated reactions are frequently related to Culex quinquefasciatus bite. OBJECTIVE: To determine the sensitivity and specificity of skin prick test with two doses of standardized extract in nitrogen protein units (PNU of Culex quinquefasciatus (BIOCEN, Cuba). MATERIAL AND METHOD: An analytical study was conducted on 100 children between 2 and 15 years old. Fifty atopic patients with a history of allergy to mosquito bite and positive specific serum IgE Culex quinquefasciatus and fifty atopic patients without a history of allergy to mosquito bite and negative specific serum IgE to Culex quinquefasciatus. Skin prick tests (SPT) were performed by duplicates on the forearms of the patients. Investigated doses were 100 PNU/mL and 10 PNU/mL. RESULTS: SPT with the highest concentration obtained a mean wheal size of 22.09 mm2 and for lower doses of 8.09 mm2, a statistically significant difference (p=0.001, Student's t test). Positive skin test correlated in 100% of patients with the presence of specific IgE. Testing with both doses showed a 94% of specificity and 88% of sensitivity. CONCLUSION: The diagnostic accuracy of SPT using both doses of standardized extract was similar, which justifies its use for diagnosis of sensitization to Culex quinquefasciatus in patients with symptoms of allergy to mosquito bite.

Antecedentes: las opciones diagnósticas de las reacciones inmunológicas a la picadura del mosquito son limitadas. En Cuba, las reacciones mediadas por IgE más frecuentes son por picadura de Culex quinquefasciatus. Objetivo: determinar la sensibilidad y especificidad de la prueba cutánea por punción con dos dosis del extracto estandarizado en unidades de nitrógeno proteico (UNP) de Culex quinquefasciatus (BIOCEN, Cuba). Material y método: estudio analítico efectuado en 100 niños entre 2 y 15 años de edad: 50 pacientes atópicos con antecedentes de alergia a la picadura de mosquito e IgE sérica específica positiva a Culex quinquefasciatus y 50 pacientes atópicos sin antecedentes de alergia a la picadura de mosquito e IgE sérica específica negativa a Culex quinquefasciatus. La prueba cutánea por punción se realizó por duplicado en los antebrazos de los pacientes. Las dosis investigadas fueron 100 y 10 UNP/mL. Resultados: en la prueba cutánea por punción con el extracto de mayor concentración se obtuvo un tamaño del área del habón de 22.09 mm2 y con la menor concentración de 8.19 mm2; una diferencia estadísticamente significativa (p=0.001, prueba t de Student). La prueba cutánea positiva se correlacionó en el 100% de los pacientes con la existencia de IgE específica. La prueba con ambas dosis mostró 94% de especificidad y 88% de sensibilidad. Conclusión: la alta coincidencia en el resultado de la prueba cutánea nos muestra que puede sustituirse la concentración del extracto a 100 UNP/mL por la de menor concentración, sin perder confiabilidad en el diagnóstico de sensibilización al mosquito Culex quinquefasciatus, utilizando ese método in vivo.

[Comparison of two lancets in the skin prick test]. / Comparación de dos lancetas en la prueba cutanea por punción.

BACKGROUND: The skin prick test is used to diagnose the allergic sensitization. Its results depend upon several factors, such as the lancet type. In Cuba, the most frequently used are: ALK lancet and blood lancet. OBJECTIVE: To compare these two lancets regarding the size of the wheal, precision, sensitivity and specificity of the skin prick test and, finally, the preference of the patients to one of them. PATIENTS AND METHODS: The study was performed in 60 allergic patients, aged 15-50 years, seen at the allergy service of Hospital Universitario Clínico Quirúrgico General Calixto García. The skin prick test was performed on the forearm of all patients included, using both lancet types. A negative control (diluent solution) was applied, together with a 54.3 mmol/L histamine solution in five replicates. RESULTS: The mean size of skin reaction to histamine was 6 mm, using a 1 mm single peak lancet (ALK), size was 6.5 mm when using blood lancet (significant difference p < 0.05). Precision, sensitivity and specificity of ALK lancet were 9.7, 100 and 100%, respectively. On the other hand, the respective values for blood lancet were 15.9, 96 and 87%. Of those studied, 27% presented mild pain and 3% moderate pain using the ALK lancet; while 25% showed mild pain and 10% moderate pain using the blood lancet. CONCLUSION: The ALK lancet showed more precision, sensitivity and specificity and it was preferred by the patients.

Prevalencia de la sensibilización a tres ácaros domésticos en la población infantil alérgica de un consultorio médico / Prevalence of sensitization to three house dust mites in the allergic infantile population of a family physician's office

Se realizó un estudio con el objetivo de investigar si la sensibilización a estos ácaros ( Dermatophagoides pteronyssinus [ Dp ], Dermatophagoides siboney [ Ds ] y Blomia tropicalis [ Bt ] ) constituye un problema de salud en nuestra población infantil, pues el estudio de los problemas alérgicos ha identificado a los ácaros domésticos como los principales agentes causales de asma y otras afecciones. Se seleccionaron 32 niños alérgicos de nuestro consultorio que se clasificaron según su grado de exposición al polvo doméstico. A todos se les realizó la prueba por punción cutánea en el brazo derecho, y se utilizaron 3 extractos alergénicos estandarizados Valergen Ò ( Blomia tropicalis, Dermatophagoides siboney y Dermatophagoides pteronyssinus ) de producción nacional (BIOCEN). La prevalencia de la sensibilización fue mayor de forma significativa (p<0,05) para todos los ácaros en los pacientes con mayor exposición al polvo doméstico con respecto a los de menor exposición. Para los ácaros del género Dermatophagoides se obtuvo una sensibilización mayor. El extracto de Dp provocó un tamaño medio del habón mayor que los otros productos.

A study was conducted aimed at investigating if the sensitization to these dust mites (Dermatophagoides pteronyssinus [Dp], Dermatophagoides siboney [Ds] and Blomia tropicalis [Bt] ) is a health problem in our infantile population, since the study of the allergic problems has identified the house dust mites as the main agents causing asthma and other affections. 32 allergic children of our office were selected and classified according to their degree of exposure to house dust. All of them underwent the skin test in the right arm. 3 standardized allergenic extracts ValergenÒ (Blomia tropicalis, Dermatophagoides siboney y Dermatophagoides pteronyssinus) of national production (BIOCEN) were used. The prevalence of sensitization was significantly higher (p<0.05) for all the dust mites in patients with a greater exposure to house dust compared with those with lower exposure to it. A higher sensitization was attained for the dust mites of the genus Dermatophagoides. The extract of Dp produced a wheal with a mean size greater than the one caused by other products.

Sensibilización a dermatophagoides pteronyssinus, dermatophagoides siboney y blomia tropicalis en niños de tres consultorios / Sensitization to dermatophagoides pteronyssinus, dermatophagoides siboney and blomia tropicalis in children from three family physician’s offices

La morbilidad de las enfermedades alérgicas mediadas por el anticuerpo IgE, se ha incrementado en los últimos 40 años y además, se han identificado a los ácaros domésticos como sus principales agentes causales. En Cuba, los ácaros más frecuentemente son: Dermatophagoides pteronyssinus (D. pteronyssinus), Dermatophagoides siboney (D. siboney) y Blomia tropicalis (B. tropicalis). En este estudio investigamos si la sensibilización a estos ácaros constituye un problema de salud en nuestra población infantil y su relación con la exposición al polvo doméstico. Se seleccionaron 103 niños alérgicos del pueblo de Guatao, que se clasificaron según su grado de exposición al polvo doméstico. A todos se les realizó la prueba por punción cutánea por duplicado en ambos antebrazos y se utilizaron los extractos alergénicos estandarizados VALERGEN-BT Ò (Blomia tropicalis), VALERGEN-DS Ò (Dermatophagoides siboney) y VALERGEN-DP Ò (Dermatophagoides pteronyssinus), todos de producción nacional en el Centro Nacional de Biopreparados. La sensibilización fue mayor de forma significativa (p<0,01) para todos los ácaros en los pacientes con mayor exposición al polvo doméstico con respecto a los de menor exposición. Además, registramos una sensibilización mayor a los ácaros del género Dermatophagoides, especialmente para el D. pteronyssinus. El extracto D. pteronyssinus provocó un tamaño medio del habón mayor que los otros productos en los pacientes positivos de ambos grupos (p<0,04), por lo que concluimos que la mayor exposición de los pacientes al polvo doméstico está relacionada con una mayor sensibilización a los ácaros