Bousquet P-J, Demoly P, Romano A, Aberer W, Bircher A, Blanca M, Brockow K, Pichler W, Torres M J, Terreehorst I, Arnoux B, Atanaskovic-Markovic M, Barbaud A, Bijl A, Bonadonna P, Burney P G, Caimmi S, Canonica G W, Cernadas J, Dahlen B, Daures J-P, Fernandez J, Gomes E, Gueant J-L, Kowalski M L, Kvedariene V, Mertes P-M, Martins P, Nizankowska-Mogilnicka E, Papadopoulos N, Ponvert C, Pirmohamed M, Ring J, Salapatas M, Sanz M L, Szczeklik A, Van Ganse E, De Weck A L, Zuberbier T, Merk H F, Sachs B, Sidoroff A
Département de Biostatistique Epidémiologie Clinique, Santé Publique et Information Médicale, GHU Carémeau, CHU Nîmes, Nîmes cedex 9, France.
Allergy. 2009 Feb;64(2):194-203. doi: 10.1111/j.1398-9995.2008.01944.x.
Nonallergic hypersensitivity and allergic reactions are part of the many different types of adverse drug reactions (ADRs). Databases exist for the collection of ADRs. Spontaneous reporting makes up the core data-generating system of pharmacovigilance, but there is a large under-estimation of allergy/hypersensitivity drug reactions. A specific database is therefore required for drug allergy and hypersensitivity using standard operating procedures (SOPs), as the diagnosis of drug allergy/hypersensitivity is difficult and current pharmacovigilance algorithms are insufficient. Although difficult, the diagnosis of drug allergy/hypersensitivity has been standardized by the European Network for Drug Allergy (ENDA) under the aegis of the European Academy of Allergology and Clinical Immunology and SOPs have been published. Based on ENDA and Global Allergy and Asthma European Network (GA(2)LEN, EU Framework Programme 6) SOPs, a Drug Allergy and Hypersensitivity Database (DAHD((R))) has been established under FileMaker((R)) Pro 9. It is already available online in many different languages and can be accessed using a personal login. GA(2)LEN is a European network of 27 partners (16 countries) and 59 collaborating centres (26 countries), which can coordinate and implement the DAHD across Europe. The GA(2)LEN-ENDA-DAHD platform interacting with a pharmacovigilance network appears to be of great interest for the reporting of allergy/hypersensitivity ADRs in conjunction with other pharmacovigilance instruments.
非过敏性超敏反应和过敏反应是多种不同类型药物不良反应（ADR）的一部分。存在用于收集药物不良反应的数据库。自发报告构成了药物警戒核心的数据生成系统，但过敏/超敏反应性药物不良反应存在大量低估情况。因此，由于药物过敏/超敏反应的诊断困难且当前的药物警戒算法不足，需要使用标准操作规程（SOP）建立一个针对药物过敏和超敏反应的特定数据库。尽管困难，但在欧洲变态反应学和临床免疫学学会的支持下，欧洲药物过敏网络（ENDA）已将药物过敏/超敏反应的诊断标准化，并已发布了标准操作规程。基于ENDA和全球变态反应和哮喘欧洲网络（GA(2)LEN，欧盟第六框架计划）的标准操作规程，在FileMaker((R)) Pro 9下建立了药物过敏和超敏反应数据库（DAHD((R))）。它已经以多种不同语言在线提供，可通过个人登录访问。GA(2)LEN是一个由27个合作伙伴（16个国家）和59个协作中心（26个国家）组成的欧洲网络，能够在全欧洲协调和实施DAHD。GA(2)LEN-ENDA-DAHD平台与药物警戒网络相互作用，对于结合其他药物警戒工具报告过敏/超敏反应性ADR似乎具有重大意义。
