氯化钠与乳糖作为屋尘螨变应原在变应原激发试验中的载体：一项评估非劣效性的临床研究。
Sodium Chloride versus Lactose as a Carrier for House Dust Mite Allergen in Allergen Chamber Studies: A Clinical Study to Assess Noninferiority.
机构信息
Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Germany.
Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany.
出版信息
Int Arch Allergy Immunol. 2023;184(11):1143-1152. doi: 10.1159/000531878. Epub 2023 Aug 16.
INTRODUCTION
In the Fraunhofer allergen challenge chamber (ACC), a standardized, universal, good manufacturing practice-conforming technology using a spray dried solution of lactose (L) and allergen extract has been established. In this study, we investigated the noninferiority of hypertonic sodium chloride (S) versus L as a carrier for house dust mite (HDM) allergen to simplify manufacturing, reduce costs, and allow for wider use.
METHODS
Using a participant-blinded, sham exposure-controlled, single-arm, sequential intervention study, we challenged adults with HDM allergic rhinitis five times in the ACC. Participants were first exposed to S, L, and clean air (block 1), followed by S + HDM and L + HDM (block 2). Primary endpoints were mean total nasal symptom score (TNSS) and mean nasal secretion weight.
RESULTS
19 participants were enrolled in the study (10 females; mean age 32 years [22-49], 4 with mild allergic asthma). The safety profile of S + HDM and L + HDM was similar; eight participants experienced mild procedure-related adverse events including tiredness, cough, and dyspnea. Due to dropouts, 13 participants completed the study and were evaluated. Mean TNSS and nasal secretion were as follows: S 0.98, 0.28 g; L 1.1, 0.20 g; clean air 1.1, 0.23 g; S + HDM 5.7, 4.8 g; L + HDM 5.1, 5.1 g. Separate block 1/block 2 MANOVAs with TNSS and nasal secretion as dependent variables revealed no significant differences between the carriers, neither alone and compared with clean air (p = 0.2059, Wilk's λ = 0.78) nor combined with HDM (p = 0.3474, Wilk's λ = 0.89). Noninferiority of S was established using a meta-analysis-based minimal clinical important difference of -0.55: mean TNSS difference between S + HDM and L + HDM was 0.62 (90% CI: -0.51 to 1.74).
CONCLUSION
S as an HDM carrier was safe and well tolerated. It was noninferior to L which makes it an adequate and easy-to-use carrier substitute.
简介
在弗劳恩霍夫变应原激发箱（ACC）中，已经建立了一种使用喷雾干燥的乳糖（L）和过敏原提取物溶液的标准化、通用、符合良好生产规范的技术。在这项研究中，我们研究了高渗氯化钠（S）作为屋尘螨（HDM）变应原载体的非劣效性，以简化制造、降低成本并允许更广泛的应用。
方法
使用参与者盲、假暴露对照、单臂、序贯干预研究，我们在 ACC 中五次挑战 HDM 过敏性鼻炎患者。参与者首先暴露于 S、L 和清洁空气（第 1 块），然后暴露于 S+HDM 和 L+HDM（第 2 块）。主要终点是总鼻症状评分（TNSS）和鼻分泌物重量的平均值。
结果
19 名参与者入组（10 名女性；平均年龄 32 岁[22-49]，4 名轻度过敏性哮喘）。S+HDM 和 L+HDM 的安全性相似；8 名参与者经历了轻度与程序相关的不良事件，包括疲劳、咳嗽和呼吸困难。由于脱落，13 名参与者完成了研究并接受了评估。平均 TNSS 和鼻分泌物如下：S 0.98，0.28g；L 1.1，0.20g；清洁空气 1.1，0.23g；S+HDM 5.7，4.8g；L+HDM 5.1，5.1g。使用 TNSS 和鼻分泌物作为因变量的单独第 1 块/第 2 块 MANOVA 分析显示，载体之间没有显著差异，无论是单独与清洁空气（p=0.2059，Wilk's λ=0.78）相比，还是与 HDM 联合使用（p=0.3474，Wilk's λ=0.89）均无差异。使用基于荟萃分析的最小临床重要差异 -0.55 确定了 S 的非劣效性：S+HDM 和 L+HDM 之间的平均 TNSS 差异为 0.62（90%CI：-0.51 至 1.74）。
结论
S 作为 HDM 载体是安全且耐受良好的。它与 L 一样非劣效，因此是一种合适且易于使用的载体替代品。
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