Université de Strasbourg, Strasbourg, France.
Curr Top Microbiol Immunol. 2011;352:43-54. doi: 10.1007/82_2011_125.
Subcutaneous immunotherapy is a well-documented treatment of allergic rhinitis and asthma. The major limitation is the risk of anaphylactic side effects. The documentation of clinical efficacy is based on crude allergenic extracts sometimes containing varying amounts of individual allergens including allergens to which the patient may not be sensitized. The introduction of recombinant allergens offer a possibility to use well-defined molecules with consistent pharmaceutical quality defined in mass units. The proof-of-concept of the clinical efficacy of recombinant allergens is based on two studies published as full articles. One study applied a mixture of five Phleum pratense major allergens in a maximum dose of 40 μg protein. The clinical efficacy showed a significant efficacy with about 40% reduction in disease severity. The second study compared a commercial birch extract with both recombinant Bet v 1 and purified Bet v 1 in dosages of 15 μg allergen. The clinical effect was around 60% additional efficacy. Systemic side effects occurred more frequently with grass allergens. A third study used hypoallergenic fragments and a trimer of Bet v 1. The study did not show efficacy and a rather high frequency of systemic side effects. The advantages of using recombinant allergens for immunotherapy are obvious but more large-scale clinical studies are needed before the overall value in terms of efficacy and safety can be determined.
皮下免疫疗法是一种经过充分证实的治疗变应性鼻炎和哮喘的方法。其主要局限性在于发生过敏副作用的风险。临床疗效的记录基于粗制过敏原提取物，这些提取物有时含有不同量的单个过敏原，包括患者可能未致敏的过敏原。重组过敏原的引入为使用具有一致药物质量的明确定义分子提供了可能性，这些分子的质量单位在数量上是定义好的。重组过敏原临床疗效的概念验证基于两项作为全文发表的研究。一项研究应用了混合物的五份普通豚草主要过敏原，最大剂量为 40 μg 蛋白质。临床疗效显示出显著的疗效，疾病严重程度降低约 40%。第二项研究比较了商业桦树提取物与重组 Bet v 1 和纯化 Bet v 1 的效果，剂量为 15 μg 过敏原。临床效果约为 60%的额外疗效。与草过敏原相比，全身副作用更频繁地发生在过敏患者身上。第三项研究使用低变应原性片段和 Bet v 1 的三聚体。该研究未显示出疗效，且全身副作用的频率较高。使用重组过敏原进行免疫疗法的优势是显而易见的，但在确定其疗效和安全性的总体价值之前，还需要进行更多大规模的临床研究。
