Hospital Médica Sur, México, D.F., Mexico.
Institute for Medical Statistics, Informatics and Epidemiology, Faculty of Medicine, University of Cologne, Cologne, Germany.
Allergy. 2016 Dec;71(12):1782-1786. doi: 10.1111/all.12998. Epub 2016 Sep 12.
In Europe, allergen extracts are standardized based on skin prick wheal size in 20-30 allergic subjects. To understand the biological activity of clinically effective Sublingual immunotherapy, we used this method to determine the biological activity of solution and tablet Timothy grass pollen (TIM) extracts, compared to an FDA-approved extract (Reference) of 10 000 BAU/ml. Blinded, quadruplicate skin prick tests with concentrate and three serial half-log dilutions allowed the construction of a semilogarithmic regression line per extract. Bioequivalent allergy units (BAU) values were obtained from the comparison with reference. Extracts and dilutions showed a neat linear dose response (all: R > 0.98) in 33 rhinitis patients. Relative potencies: Staloral 12 000 BAU/ml, Soluprick 10 300 BAU/ml, Oralair 8200 BAU, and Grazax 6200 BAU. Even though all extract concentrates differed in wheal size (P = 0.01-0.001), Grazax producing a 25% smaller wheal size than Oralair , and the biological activity of these clinically effective TIM tablets led in the same range (6200-8200 BAU; 0.92-1.23 cm ). SLIT dose-finding studies for other pollens might start with allergen extracts producing 1.1 cm wheal surface.
在欧洲，过敏原提取物是根据 20-30 名过敏受试者的皮肤划痕风团大小进行标准化的。为了了解具有临床疗效的舌下免疫疗法的生物学活性，我们使用该方法来确定溶液和片剂梯牧草花粉（TIM）提取物的生物学活性，将其与 FDA 批准的 10000 BAU/ml 的提取物（参考）进行比较。采用盲法、一式四份的浓缩液和三个连续半对数稀释液的皮肤划痕试验，允许为每种提取物构建半对数回归线。通过与参考品的比较获得等效过敏单位（BAU）值。提取物和稀释液在 33 名鼻炎患者中显示出整洁的线性剂量反应（全部：R>0.98）。相对效力：Staloral 12000 BAU/ml、Soluprick 10300 BAU/ml、Oralair 8200 BAU/ml 和 Grazax 6200 BAU/ml。尽管所有提取物的浓缩液在风团大小上存在差异（P=0.01-0.001），但 Grazax 产生的风团比 Oralair 小 25%，这些具有临床疗效的 TIM 片剂的生物活性也在相同范围内（6200-8200 BAU；0.92-1.23cm）。对于其他花粉的 SLIT 剂量发现研究，可能从产生 1.1cm 风团表面的过敏原提取物开始。
Zotero 插件