杭州浙大迪迅生物基因工程有限公司

        過敏原免疫療法(AIT) 在歐洲和北美被認(rèn)為在過敏性鼻炎、哮喘和昆蟲叮咬過敏的治療上是臨床有效和安全的，然而，AIT治療產(chǎn)品在應(yīng)用和管理方面，兩地之間存在著差異。在北美，未經(jīng)修飾的標(biāo)準(zhǔn)化和非標(biāo)準(zhǔn)化的水溶性氣傳過敏原提取物被批準(zhǔn)并幾乎完全用于皮下免疫治療，而在歐洲，有更多的產(chǎn)品選擇，包括吸附變應(yīng)原、化學(xué)修飾變應(yīng)原，或兩者兼而有之。在歐洲，液體提取物和藥片都被批準(zhǔn)用于舌下免疫治療。然而，在歐盟內(nèi)部，在不同國家批準(zhǔn)和使用的AIT產(chǎn)品存在重大差異。多種過敏原致敏患者皮下免疫治療的臨床方法存在較大差異，在美國，使用含有多種氣傳過敏原的混合提取物，而歐洲的過敏學(xué)家喜歡使用單一變應(yīng)原來源或被認(rèn)為與臨床相關(guān)的同源組進(jìn)行單獨(dú)注射。此外，歐盟和美國的監(jiān)管方式不同。美國有基于生物活性的通用過敏原標(biāo)準(zhǔn)，而歐洲沒有通用標(biāo)準(zhǔn)。在開發(fā)新的研究產(chǎn)品方面，美國在第二階段和第三階段的研究仿效歐洲的做法;美國食品和藥物管理局尚未發(fā)布正式的指導(dǎo)意見。

延伸閱讀
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.EschPhDbJ?rgKleine-TebbeMDcWilliam J.LaveryMD, PhDdGregPlunkettPhDeStefanViethsPhDa?David I.BernsteinMDd?

 2019-3-27  review