Faculté de Médecine, Université de Strasbourg, Strasbourg, France.
Curr Opin Allergy Clin Immunol. 2010 Dec;10(6):575-81. doi: 10.1097/ACI.0b013e32833fd6c5.
Subcutaneous immunotherapy is a well documented treatment of allergic rhinitis and asthma. The majority of the disadvantages of the treatment are related to the poor quality of the natural allergen extracts which can contain varying amounts of individual allergens including allergens to which the patient may not be sensitized. 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 40mcg protein. The clinical efficacy showed a significant efficacy with 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 15mcg allergen. The clinical effect was 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 studies on a large scale are needed before the overall value in terms of efficacy and safety can be assessed. Clinical trials are also necessary for new combined vaccines based on recombinant allergens that in experimental studies have shown greatly enhanced immunogenicity and low allergen-specific reactivity.
皮下免疫疗法是一种被充分证实的变应性鼻炎和哮喘治疗方法。该疗法的大多数缺点都与天然变应原提取物的质量较差有关，这些提取物可能含有不同量的单一过敏原，包括患者可能没有致敏的过敏原。重组过敏原提供了一种使用定义明确的分子的可能性，这些分子具有一致的药物质量，以质量单位定义。重组过敏原临床疗效的概念验证基于两篇已全文发表的研究。
一项研究应用了混合物中的 5 种 Phleum pratense 主要过敏原，最大剂量为 40mcg 蛋白。临床疗效显示出显著的疗效，疾病严重程度降低了 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 的剂量为 15mcg 过敏原。临床效果为 60%的额外疗效。与草过敏原相比，系统性副作用更频繁地发生在桦树过敏原中。第三项研究使用了低变应原性片段和 Bet v 1 的三聚体。该研究未显示出疗效，且系统性副作用的频率较高。
使用重组过敏原进行免疫疗法的优势显而易见，但在评估疗效和安全性方面的总体价值之前，还需要进行更多的大规模研究。基于重组过敏原的新联合疫苗也需要临床试验，这些疫苗在实验研究中显示出了极大的免疫原性和低的过敏原特异性反应性。
