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Abstract：
BACKGROUND: Nasal allergen challenge (NAC) is used to investigate the effects of allergen exposure and assess treatment efficacy in allergic rhinitis (AR). This study aims to establish dose-responses to NAC using licensed silver birch (SB) pollen and house dust mite (HDM) sublingual tablets as sources of the allergen extracts in participants with AR.
METHODS: Sixteen volunteers with HDM-induced perennial AR and 15 volunteers with SB pollen-induced seasonal rhinitis underwent a graded up-dosing NAC with extracts derived from HDM allergen (Acarizax®) and SB (Itulazax®) tablets, respectively. Total nasal symptom score (TNSS, range 0-12) and peak nasal inspiratory flow (PNIF) were recorded before, at 10 min and at the end of the NAC. The dose of each allergen that provoked a TNSS of at least 7 (\"provoking dose 7\") in most allergic participants was identified. NACs using the \"provoking dose 7\" were performed on 5 non-allergic individuals to test for irritant effects. The \"provoking dose 7\" of HDM extract was used in a subgroup of two SB allergic, non-HDM allergic, volunteers, and vice versa for SB extract, to test for allergen specificity of the responses.
RESULTS: Most patients experienced a TNSS of at least 7/12 at a median concentration of 1500 AU/mL for both SB pollen and HDM. The average decline in PNIF at this dose was 63.15% for SB and 63.99% for HDM. NACs using the 1500 AU/mL concentrations were performed on 5 non-allergic individuals with no symptomatic or PNIF response. 1500 AU/mL of HDM extract produced no symptoms in SB allergics nor 1500 AU/mL SB extract in HDM allergics.
CONCLUSIONS: For both SB and HDM extracts, the optimal allergen dose for NAC to cause a moderate-severity response (\"provoking dose 7/12\") was 1500 AU/mL. Licensed sublingual allergen tablets provide a readily available and inexpensive source of SB and HDM extracts for use in future interventional studies in AR.
METHODS: Sixteen volunteers with HDM-induced perennial AR and 15 volunteers with SB pollen-induced seasonal rhinitis underwent a graded up-dosing NAC with extracts derived from HDM allergen (Acarizax®) and SB (Itulazax®) tablets, respectively. Total nasal symptom score (TNSS, range 0-12) and peak nasal inspiratory flow (PNIF) were recorded before, at 10 min and at the end of the NAC. The dose of each allergen that provoked a TNSS of at least 7 (\"provoking dose 7\") in most allergic participants was identified. NACs using the \"provoking dose 7\" were performed on 5 non-allergic individuals to test for irritant effects. The \"provoking dose 7\" of HDM extract was used in a subgroup of two SB allergic, non-HDM allergic, volunteers, and vice versa for SB extract, to test for allergen specificity of the responses.
RESULTS: Most patients experienced a TNSS of at least 7/12 at a median concentration of 1500 AU/mL for both SB pollen and HDM. The average decline in PNIF at this dose was 63.15% for SB and 63.99% for HDM. NACs using the 1500 AU/mL concentrations were performed on 5 non-allergic individuals with no symptomatic or PNIF response. 1500 AU/mL of HDM extract produced no symptoms in SB allergics nor 1500 AU/mL SB extract in HDM allergics.
CONCLUSIONS: For both SB and HDM extracts, the optimal allergen dose for NAC to cause a moderate-severity response (\"provoking dose 7/12\") was 1500 AU/mL. Licensed sublingual allergen tablets provide a readily available and inexpensive source of SB and HDM extracts for use in future interventional studies in AR.
摘要：
背景：鼻过敏原激发（NAC）用于研究过敏原暴露的影响并评估过敏性鼻炎（AR）的治疗效果。这项研究旨在使用许可的白桦树（SB）花粉和屋尘螨（HDM）舌下片作为AR参与者的过敏原提取物来源，建立对NAC的剂量反应。
方法：16名患有HDM诱导的多年性AR的志愿者和15名患有SB花粉诱导的季节性鼻炎的志愿者接受了由HDM过敏原（Acarizax®）和SB（Itulazax®）片剂提取物的分级剂量增加NAC，分别。鼻部症状总评分（TNSS，范围0-12）和峰值鼻吸气流量（PNIF）记录之前，在10分钟和NAC结束时。确定了在大多数过敏参与者中引起至少7的TNSS的每种过敏原的剂量（“引起剂量7”）。使用“激发剂量7”对5名非过敏个体进行NAC，以测试刺激作用。HDM提取物的“激发剂量7”用于两个SB过敏的亚组，非HDM过敏，志愿者,对于SB提取物，反之亦然，测试反应的过敏原特异性。
结果：对于SB花粉和HDM，大多数患者在1500AU/mL的中值浓度下经历了至少7/12的TNSS。在此剂量下PNIF的平均下降对于SB为63.15%,对于HDM为63.99%。使用1500AU/mL浓度的NAC对5个没有症状或PNIF反应的非过敏性个体进行。1500AU/mL的HDM提取物在SB过敏原中没有产生症状，在HDM过敏原中也没有1500AU/mL的SB提取物。
结论：对于SB和HDM提取物，NAC引起中度反应的最佳过敏原剂量(“激发剂量7/12”)为1500AU/mL.许可的舌下过敏原片剂提供了易于获得且廉价的SB和HDM提取物来源，可用于AR的未来介入研究。
方法：16名患有HDM诱导的多年性AR的志愿者和15名患有SB花粉诱导的季节性鼻炎的志愿者接受了由HDM过敏原（Acarizax®）和SB（Itulazax®）片剂提取物的分级剂量增加NAC，分别。鼻部症状总评分（TNSS，范围0-12）和峰值鼻吸气流量（PNIF）记录之前，在10分钟和NAC结束时。确定了在大多数过敏参与者中引起至少7的TNSS的每种过敏原的剂量（“引起剂量7”）。使用“激发剂量7”对5名非过敏个体进行NAC，以测试刺激作用。HDM提取物的“激发剂量7”用于两个SB过敏的亚组，非HDM过敏，志愿者,对于SB提取物，反之亦然，测试反应的过敏原特异性。
结果：对于SB花粉和HDM，大多数患者在1500AU/mL的中值浓度下经历了至少7/12的TNSS。在此剂量下PNIF的平均下降对于SB为63.15%,对于HDM为63.99%。使用1500AU/mL浓度的NAC对5个没有症状或PNIF反应的非过敏性个体进行。1500AU/mL的HDM提取物在SB过敏原中没有产生症状，在HDM过敏原中也没有1500AU/mL的SB提取物。
结论：对于SB和HDM提取物，NAC引起中度反应的最佳过敏原剂量(“激发剂量7/12”)为1500AU/mL.许可的舌下过敏原片剂提供了易于获得且廉价的SB和HDM提取物来源，可用于AR的未来介入研究。
