Determinação da potência relativa de extratos alergênicos de Phleum pratense por testes cutâneos
Establishing the relative potency of Phleum pratense allergenic extracts using skin prick tests
Nelson A. Rosario Filho; Elizabeth M. Mercer Mourão; Alessandra dos Santos Bitencourt; Cristine S. Rosario; Désirée E.S. Larenas Linnemann
Resumo
Objetivos: Comparar a potência de extratos europeus de Phleum pratense para imunoterapia sublingual (ITSL), em relação ao extrato referência norte-americano. Métodos: Foram selecionados 15 sujeitos, com idade entre 18 e 55 anos, histórico clínico sazonal compatível e teste cutâneo com alta reatividade a gramíneas. O delineamento de estudo foi transversal, triplo cego e randômico, e comparadas as potências dos seguintes extratos alergênicos para ITSL: (A) Soluprick® (30 HEP/mL) e (B) Grazax® 75.000 SQ-T, ambos os extratos da ALK-Abelló; (C) Oralair® e (D) Staloral®, com 300 IR/mL, Stallergènes, França. O extrato de origem norteamericana (E) foi o padrão, contendo 10.000 BAU/mL. Todos os extratos foram usados em forma de concentrados e nas diluições 1:3, 1:10, e 1:30. Os testes foram aplicados em quadruplicata em dois dias não consecutivos. Os diâmetros de pápula e eritema foram registrados após 15 minutos. Resultados: Não houve diferença significativa entre os testes realizados no primeiro e segundo dias (p = 0,37) com extratos concentrados, na diluição 1:3 e também 1:10 (p = 0,20 e p = 0,33, respectivamente). No segundo dia de testes, a média obtida das pápulas do extrato A foi de 16,7 mm na diluição 1:3; de 14,3 mm na diluição 1:10; e de 9,8 mm na diluição 1:30. Houve diferenças significativas entre os extratos A, B, C, D e E na comparação entre as médias das pápulas obtidas em todas as diluições, mostrando diferença de potência entre os extratos. O diâmetro das pápulas obtidas com o material concentrado, em ordem decrescente de potência, foram C > A > E > D > B. As reações observadas com extratos concentrados mostrou que o mais potente foi Staloral, e o menos potente Grazax. Conclusões: Houve variabilidade significativa de potência nos diversos extratos comparados. Isto reforça a necessidade de padronização de extratos alergênicos para ITSL.
Palavras-chave
Abstract
Objectives: To compare the potency of European Phleum pratense pollen extracts for sublingual immunotherapy (SLIT) compared to the U.S. reference extract. Methods: Fifteen subjects aged between 18 and 55 years, with compatible seasonal clinical history and skin tests highly reactive to grass, were selected. The design was cross-sectional, blind, randomized. The following extracts were compared for SLIT: (A) Soluprick® (30 HEP/mL) and (B) Grazax® 75,000 SQ-T, both from ALK-Abelló; (C) Oralair® and (D) Staloral®, with 300 IR/mL, Stallergènes, France. The American extract (E) was the standard 10,000 BAU/mL. Extracts were used in concentrate form and also diluted in 1:3, 1:10, and 1:30 ratios. Tests were applied in quadruplicate on two nonconsecutive days. Skin test reading were done after 15 minutes. Results: There were no significant differences between the tests conducted on the first and second days with the extracts in concentrate form (p = 0.37) or diluted at 1:3 or 1:10 (p = 0.20, p = 0.33, respectively). On the second day of tests, mean wheal sizes obtained with extract A were 16.7 mm with the 1:3 dilution, 14.3 mm with the 1:10 dilution, and 9.8 mm with the 1:30 dilution. There were significant differences between extracts A, B, C, D and E when comparing mean wheal sizes obtained with all dilutions, demonstrating differences in the extracts’ potency. Mean wheal diameters obtained with the concentrates, in decreasing order of potency, were C > A > E > D > B. The reactions showed that the most potent extract was Staloral, and the least potent, Grazax. Conclusions: There were significant potency variations in the different extracts assessed. These results reinforce the need for standardization of allergenic extracts used for SLIT.
Keywords
Referências
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Submetido em:
23/02/2018
Aceito em:
26/02/2018
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