Division of Vaccines and Related Products Applications, US Food and Drug Administration, Silver Spring, Maryland.
Division of Bacterial, Parasitic and Allergenic Products, US Food and Drug Administration, Silver Spring, Maryland.
Ann Allergy Asthma Immunol. 2017 May;118(5):531-536. doi: 10.1016/j.anai.2016.05.026.
To review allergenic extracts used to diagnose or treat insect allergies, including how the extracts are manufactured and their measurements of potency or concentration.
Peer-reviewed articles derived from searching PubMed (National Center for Biotechnology Information) about insect allergies and extract preparation. Encyclopedia of Life (http://www.eol.org/) and http://allergome.org/ were also referenced for background information on insects and associated allergens.
Search terms used for the PubMed searches included insect allergens and allergies, Apidae, Vespidae, fire ants, cockroach allergies, insect allergen extract preparation, and standardization.
Humans may be sensitized to insect allergens by inhalation or through stings. Cockroaches and moths are predominantly responsible for inhalation insect allergy and are a major indoor allergen in urban settings. Bees, fire ants, and wasps are responsible for sting allergy. In the United States, there are multiple insect allergen products commercially available that are regulated by the US Food and Drug Administration. Of those extracts, honeybee venom and insect venom proteins are standardized with measurements of potency. The remaining insect allergen extracts are nonstandardized products that do not have potency measurements.
Sensitization to inhalational and stinging insect allergens is reported worldwide. Crude insect allergen extracts are used for diagnosis and specific immunotherapy. A variety of source materials are used by different manufacturers to prepare these extracts, which may result in qualitative differences that are not reflected in measurements of potency or protein concentration.
综述用于诊断或治疗昆虫过敏的变应原提取物，包括提取物的生产方法及其效价或浓度的测量。
从 PubMed（美国国家生物技术信息中心）中搜索关于昆虫过敏和提取物制备的同行评议文章。还参考了《生命百科全书》（http://www.eol.org/）和 http://allergome.org/，以获取有关昆虫和相关变应原的背景信息。
用于 PubMed 搜索的检索词包括昆虫变应原和过敏、蜜蜂科、胡蜂科、火蚁、蟑螂过敏、昆虫变应原提取物制备和标准化。
人类可能通过吸入或刺伤对昆虫变应原产生过敏。蟑螂和蛾类主要引起吸入性昆虫过敏，是城市环境中主要的室内过敏原。蜜蜂、火蚁和胡蜂引起刺伤过敏。在美国，有多种商业上可获得的昆虫变应原产品受到美国食品和药物管理局的监管。在这些提取物中，蜂毒液和昆虫毒液蛋白具有效价的标准化测量。其余的昆虫变应原提取物是非标准化产品，没有效价测量。
全世界都有报道称对吸入性和刺伤性昆虫变应原过敏。粗制昆虫变应原提取物用于诊断和特异性免疫治疗。不同制造商使用各种来源的材料来制备这些提取物，这可能导致质量上的差异，而这些差异在效价或蛋白浓度的测量中没有反映出来。
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