Manzotti G, Lombardi C
Allergy Outpatients Service, General Hospital, Treviglio, Italy.
Eur Ann Allergy Clin Immunol. 2013 Apr;45(2):34-42.
Currently, sublingual immunotherapy (SLIT) may be performed by a number of allergen extract in different preparations but in a near future only products fulfilling the requirements from the regulatory agencies, that make mandatory a pharmaceutical quality, will be authorized. Indeed, two products with such characteristics are already available for SLIT in grass pollen allergic patients, Grazax from Alk-Abellò and Oralair from Stallergenes. The data from registrative trials as well as from postmarketing studies provide evidence of efficacy and safety of such products. This articles reviews the similarities and the differences of Grazax and Oralair, both designed as drugs for the treatment of grass pollen allergy with the aim, which is exclusive of allergen immunotherapy, to work on the natural history of allergy and not only on symptoms as rescue medications do. The aim of this paper is to evaluate the available trials with Grazax and Oralair in terms of pre-seasonal schedule approach to support their use in clinical practice. Such kind of treatment makes possible a continuous dialogue between clinical investigators and clinical practitioners, and is the only way for scientific progress that puts the patient's health at the first place.
目前,舌下免疫疗法(SLIT)可以使用多种不同制剂的变应原提取物来进行,但在不久的将来,只有符合监管机构要求(这些要求强制规定了药品质量)的产品才会被批准。事实上,已有两种具有此类特性的产品可用于对草花粉过敏患者进行SLIT,即ALK-阿贝罗公司的Grazax和Stallergenes公司的Oralair。注册试验以及上市后研究的数据证明了此类产品的有效性和安全性。本文回顾了Grazax和Oralair的异同,这两种产品均被设计为用于治疗草花粉过敏的药物,其目的(这与变应原免疫疗法不同)是作用于过敏的自然病程,而不仅仅像急救药物那样只作用于症状。本文的目的是根据季前给药方案评估有关Grazax和Oralair的现有试验,以支持它们在临床实践中的应用。这种治疗方式使得临床研究人员和临床医生之间能够进行持续对话,并且是将患者健康置于首位的科学进步的唯一途径。