Immunotherapy · 2016
Randomized dose-response study of subcutaneous immunotherapy with a Dermatophagoides pteronyssinus extract in patients with respiratory allergy.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Moreno Victoria, Alvariño Marta, Rodríguez Fernando, Roger Albert, Peña-Arellano María Isabel, Lleonart Ramón, Pagán Juan Antonio, Navarro José Antonio, Navarro Luís Angel, Vidal Carmen, Ponte-Tellechea Ana, Gómez-Fernández María Cruz, Madariaga-Goirigolzarri Begoña, Asturias Juan Andrés, Hernández-Fernandez de Rojas Dolores
Аннотация
AIM: To evaluate the efficacy of Dermatophagoides pteronyssinus (DPT) subcutaneous immunotherapy in allergic rhinoconjunctivitis patients.
PATIENTS & METHODS: This 17-week double-blind study randomized 136 patients (95 evaluable) to five dose groups of DPT depot extract (0.0625-0.75 skin prick test [SPT] units) or placebo, administered in a six updosing schedule.
RESULTS: A dose-response was observed for clinical efficacy (allergen concentration needed to induce a positive nasal provocation test response from baseline to final visit) and safety (adverse reactions). Local and systemic reactions occurred with 14.8 and 6.4% of administered doses, respectively; a single anaphylactic reaction occurred in each of Groups 3, 4 and 5 (0.3% of doses).
CONCLUSION: The risk-benefit profile appeared most favorable with a DPT dose of 0.125 SPT units.
PATIENTS & METHODS: This 17-week double-blind study randomized 136 patients (95 evaluable) to five dose groups of DPT depot extract (0.0625-0.75 skin prick test [SPT] units) or placebo, administered in a six updosing schedule.
RESULTS: A dose-response was observed for clinical efficacy (allergen concentration needed to induce a positive nasal provocation test response from baseline to final visit) and safety (adverse reactions). Local and systemic reactions occurred with 14.8 and 6.4% of administered doses, respectively; a single anaphylactic reaction occurred in each of Groups 3, 4 and 5 (0.3% of doses).
CONCLUSION: The risk-benefit profile appeared most favorable with a DPT dose of 0.125 SPT units.