杭州浙大迪迅生物基因工程有限公司

        过敏原免疫疗法(AIT) 在欧洲和北美被认为在过敏性鼻炎、哮喘和昆虫叮咬过敏的治疗上是临床有效和安全的，然而，AIT治疗产品在应用和管理方面，两地之间存在着差异。在北美，未经修饰的标准化和非标准化的水溶性气传过敏原提取物被批准并几乎完全用于皮下免疫治疗，而在欧洲，有更多的产品选择，包括吸附变应原、化学修饰变应原，或两者兼而有之。在欧洲，液体提取物和药片都被批准用于舌下免疫治疗。然而，在欧盟内部，在不同国家批准和使用的AIT产品存在重大差异。多种过敏原致敏患者皮下免疫治疗的临床方法存在较大差异，在美国，使用含有多种气传过敏原的混合提取物，而欧洲的过敏学家喜欢使用单一变应原来源或被认为与临床相关的同源组进行单独注射。此外，欧盟和美国的监管方式不同。美国有基于生物活性的通用过敏原标准，而欧洲没有通用标准。在开发新的研究产品方面，美国在第二阶段和第三阶段的研究仿效欧洲的做法;美国食品和药物管理局尚未发布正式的指导意见。

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JACI                                                      

Understanding differences in allergen immunotherapy products and practices in North America
https://doi.org/10.1016/j.jaci.2019.01.024
 Abstract:
Allergen immunotherapy (AIT) is thought to be clinically effective and safe in treating allergic rhinitis, asthma, and stinging insect allergy in Europe and North America. However, there are intercontinental differences in AIT therapeutic products in terms of their application and regulation. In North America unmodified standardized and nonstandardized aqueous aeroallergen extracts are approved and used almost exclusively for subcutaneous immunotherapy, whereas more product options are available in Europe, including adsorbed allergens, chemically modified allergens, or both. Both liquid extracts and tablets are approved for sublingual immunotherapy in Europe. Nevertheless, within the European Union, there are major differences in AIT products approved and used in individual countries. There are major differences in the clinical approach to subcutaneous immunotherapy in polysensitized patients; in the United States mixed extracts containing multiple aeroallergens are used, whereas European allergists preferably administer separate injections of single allergen sources or homologous groups deemed to be clinically relevant. Moreover, the regulatory approach differs between the European Union and United States. In contrast to the United States, where common allergen standards exist based on biologic activity, no common standards exist in Europe. In terms of development of new investigational products, the United States has followed the European example for phase II and III studies; no formal US Food and Drug Administration guidance has been issued.
All Author:
VeraMahlerMDaRobert E.EschPhDbJörgKleine-TebbeMDcWilliam J.LaveryMD, PhDdGregPlunkettPhDeStefanViethsPhDa∗David I.BernsteinMDd∗

 2019-3-27  review