A prospective and multicenter safety-monitoring study of a short up-dosing schedule of immunotherapy with a mass-units-standardized extract of mites.

A prospective, multicenter pharmacovigilance study was carried out to evaluate the safety of a new 7-dose treatment schedule of subcutaneous immunotherapy as opposed to the conventional 13 doses normally recommended. The study was carried out in 14 centers and included 261 patients (children and adults) with respiratory allergic disease due to sensitization to mites (Dermatophagoides pteronyssinus and/or farinae). A total of 2290 doses were administered under the direct supervision of the participating specialists. One hundred and ten reactions in 63 patients (24.1%) were recorded, representing 4.8% of the total doses administered. Most of the reactions (98) were local. Only 12 were systemic (0.5% of the administered doses) and occurred in 10 patients (3.8% of the sample). Ten reactions reverted quickly with rescue medication. The maintenance dose had to be lowered in one patient and another patient was withdrawn from the study after suffering two asthmatic crises after two consecutive doses. In view of the results obtained, we can conclude that the new schedule shows an acceptable tolerance profile and does not present a greater risk of reactions than the conventional scheme of 13 doses using an identical extract. Moreover, the new schedule represents substantial savings in the number of doses and visits required to reach the maintenance dose.

A prospective and multicenter safety-monitoring study of a short up-dosing schedule of immunotherapy with a mass-units-standardized extract of mites

A prospective, multicenter pharmacovigilance study was carried out to evaluate the safety of a new 7-dose treatment schedule of subcutaneous immunotherapy as opposed to the conventional 13 doses normally recommended. The study was carried out in 14 centers and included 261 patients (children and adults) with respiratory allergic disease due to sensitization to mites (Dermatophagoides pteronyssinus and/or farinae). A total of 2290 doses were administered under the direct supervision of the participating specialists. One hundred and ten reactions in 63 patients (24.1 %) were recorded, representing 4.8 % of the total doses administered. Most of the reactions (98) were local. Only 12 were systemic (0.5 % of the administered doses) and occurred in 10 patients (3.8 % of the sample). Ten reactions reverted quickly with rescue medication. The maintenance dose had to be lowered in one patient and another patient was withdrawn from the study after suffering two asthmatic crises after two consecutive doses. In view of the results obtained, we can conclude that the new schedule shows an acceptable tolerance profile and does not present a greater risk of reactions than the conventional scheme of 13 doses using an identical extract. Moreover, the new schedule represents substantial savings in the number of doses and visits required to reach the maintenance dose (AU)

Se ha llevado a cabo un estudio prospectivo y multicéntrico de farmacovigilancia, con el objetivo de valorar la seguridad de una nueva pauta en inmunoterapia subcutánea de 7 dosis, frente a las 13 de la pauta convencional habitualmente recomendada. El estudio se realizó en 14 centros, incluyéndose 261 pacientes (niños y adultos) con enfermedad alérgica respiratoria por sensibilización a ácaros (Dermatophagoides pteronyssinus y/o farinae). Se administraron un total de 2.290 dosis, todas ellas bajo la supervisión directa de los especialistas participantes. Se registraron 110 reacciones en 63 pacientes (24,1 por ciento), lo que supone un porcentaje sobre el total de dosis administradas del 4,8 por ciento. La mayoría de reacciones (98) fueron locales. Tan sólo 12 fueron sistémicas (0,5 por ciento sobre las dosis administradas) las cuales ocurrieron en 10 pacientes (3,8 por ciento de la muestra). En 10 casos revertieron rápidamente con medicación de alivio, en 1 caso fue necesario bajar la dosis de mantenimiento, y en 1 paciente se decidió retirarle del estudio por padecer 2 crisis asmáticas en dos dosis consecutivas. A la vista de los resultados obtenidos, podemos concluir que la nueva pauta ensayada presenta un adecuado perfil de tolerancia, no existiendo mayor riesgo de reacciones al compararlo con el perfil de la pauta convencional de 13 dosis utilizando idéntico extracto. Además, la nueva pauta supone un notable ahorro en el número de dosis y visitas necesarias para alcanzar la dosis de mantenimiento (AU)

Anaphylaxis to erythromycin.

BACKGROUND: Erythromycin and its salts belong to the larger class of macrolides. Erythromycin is well tolerated. The most common side effects are gastrointestinal distress, nausea, and vomiting, which are dose related. Allergic and pseudoallergic reactions due to macrolide antibiotics are uncommon. Anaphylaxis and acute respiratory distress appear in the literature as case reports. METHODS: We report a 24-year-old man who presented 12 years ago a systemic allergic reaction to penicillin, confirmed by skin tests and detection of specific IgE (RAST). Since then he had tolerated erythromycin on several occasions. Nine months ago, his general practitioner prescribed erythromycin orally as treatment for a respiratory infection. Thirty minutes after taking the first dose, 500 mg, he developed an anaphylactic reaction. The episode subsided with treatment with high dose corticosteroids, antihistamines, and epinephrine. Skin prick tests and intradermal tests were performed with erythromycin at different concentrations. We also measured total IgE and specific IgE to erythromycin by CAP and Phadezym RAST (Pharmacia, Uppsala, Sweden), respectively. We also performed a Prausnitz-Küstner test (PK test), and oral challenge test. RESULTS: Skin testing to erythromycin was not helpful because of cutaneous hyperreactiviness. No significant levels of specific IgE to erythromycin were detected. The oral challenge and the Prausnitz-Küstner test were positive. CONCLUSIONS: The positive history and oral challenge test suggested an anaphylactic reaction to erythromycin. The positive Prausnitz-Küstner test demonstrated the presence of specific IgE to erythromycin.

Labiatae allergy: systemic reactions due to ingestion of oregano and thyme.

BACKGROUND: There are no cases described in the medical literature of systemic allergic reactions due to oregano (Origanum vulgare) or thyme (Thymus vulgaris). These herbs belong to the Lamiaceae (Labiatae) family which comprises other plants such as hyssop (Hyssopus officinalis), basil (Ocimum basilicum), marjoram (Origanum majorana), mint (Mentha piperita), sage (Salvia officinalis) and lavender (Lavandula officinalis). OBJECTIVE: We describe three systemic allergic reactions caused by oregano and thyme in the same patient. METHODS: Skin tests with inhalant allergens and plants of the Labiatae family were done. We used the prick by prick technique with dried commercial plants and prick tests with extracts prepared with the Frugoni method in our patient and in ten control patients. Total serum IgE was determined by Phadezym IgE PRIST (Pharmacia). Specific IgE was measured by two methods: CAP system (Pharmacia) and Phadezym RAST (Pharmacia Diagnostics, Uppsala, Sweden) with activated discs of the allergenic extracts that were prepared in our laboratory. RESULTS: Skin tests with inhalants were positive to grasses. Skin tests with plants of the Labiatae family were positive in all cases when the skin prick technique was used; tests were negative with basil and lavender, and positive with all the others when we used the prick by prick technique. We did not detect any positive skin tests nor specific IgE to plants of the Labiatae family in control patients. Total serum IgE was 406 U/mL. Specific IgE was detected to all herbs tested; higher levels were obtained with the CAP system. CONCLUSIONS: Plants belonging to the Labiatae family seem to show cross-sensitivity on the basis of clinical history and in vitro and in vivo test results.

Mustard allergy: three cases of systemic reaction to ingestion of mustard sauce.

Very few cases of hypersensitivity due to ingestion of mustard have been described in the literature, although this spice enjoys widespread use. We present three cases of anaphylactic reactions to ingestion of a small amount of mustard sauce. In our patients we performed skin prick tests with mustard and with the rest of the vegetables belonging to the Cruciferae family. We also performed skin prick tests with common pneumoallergens. We measured specific serum IgE to mustard using the CAP System (Pharmacia). Oral challenges with the other vegetables of the Cruciferae family were performed in the patients with no evidence of previous tolerance. Skin prick tests and specific serum IgE determinations to mustard were positive in all three patients. The tests with the rest of the vegetables belonging to the same family were negative. In conclusion, we consider that skin prick tests and the measurement of specific serum IgE to mustard are good methods for the diagnosis of mustard hypersensitivity. We did not detect cross-sensitivity with other vegetables of the same family or with pneumoallergens.