杭州浙大迪迅生物基因工程有限公司

　　原标题：过敏原提取物用于体内诊断和治疗：还有未来吗
　　目前，体内过敏诊断和过敏原特异性免疫治疗(allergen-specific immuntreatment, AIT)仍以天然过敏原来源提取的过敏原提取物为基础。一些分析天然过敏原提取物成分的研究显示，天然过敏原提取物的质量存在严重问题，如存在未明确的非过敏原物质、污染物，以及单个过敏原的含量和生物活性变化较大。尽管先进的分析技术越来越多，但这些问题是无法克服的，因为它们是过敏原来源和提取方法所固有的。针对天然过敏原提取物的体外过敏诊断问题，通过对纯净度和生物活性进行定义的重组过敏原分子的应用，已在很大程度上克服了这些问题。然而，过敏原制剂在体内用于诊断和治疗还没有取得任何进展。目前尚无临床研究对用于体内过敏诊断的过敏原提取物进行安全性、敏感性和特异性的记录。只有非常少的治疗性过敏原提取物进行了最先进的临床研究，为安全性和有效性提供证据。在这篇文章中，我们讨论了基于天然过敏原提取物的产品质量不一致的问题，并分享了我们的观察结果，即大多数可用于体内诊断的产品和AIT不符合国际药品标准。我们认为，通过定义重组产生的过敏原分子和/或其混合物来替代天然过敏原提取物，可能是保证未来临床医生提供最先进的药物产品用于过敏患者的体内诊断和治疗的唯一途径。
　　延伸阅读
JACI：
Allergen Extracts for In Vivo Diagnosis and Treatment of Allergy: Is There a Future?
https://doi.org/10.1016/j.jaip.2018.08.032
Abstract:
Today, in vivo allergy diagnosis and allergen-specific immunotherapy (AIT) are still based on allergen extracts obtained from natural allergen sources. Several studies analyzing the composition of natural allergen extracts have shown severe problems regarding their quality such as the presence of undefined nonallergenic materials, contaminants as well as high variabilities regarding contents and biological activity of individual allergens. Despite the increasing availability of sophisticated analytical technologies, these problems cannot be overcome because they are inherent to allergen sources and methods of extract production. For in vitro allergy diagnosis problems related to natural allergen extracts have been largely overcome by the implementation of recombinant allergen molecules that are defined regarding purity and biological activity. However, no such advances have been made for allergen preparations to be used in vivo for diagnosis and therapy. No clinical studies have been performed for allergen extracts available for in vivo allergy diagnosis that document safety, sensitivity, and specificity of the products. Only for very few therapeutic allergen extracts state-of-the-art clinical studies have been performed that provide evidence for safety and efficacy. In this article, we discuss problems related to the inconsistent quality of products based on natural allergen extracts and share our observations that most of the products available for in vivo diagnosis and AIT do not meet the international standards for medicinal products. We argue that a replacement of natural allergen extracts by defined recombinantly produced allergen molecules and/or mixtures thereof may be the only way to guarantee the supply of clinicians with state-of-the-art medicinal products for in vivo diagnosis and treatment of allergic patients in the future.
All Authors:
RudolfValentaMDabcAlexanderKaraulovMDcVerenaNiederbergerMDdYuryZhernovPhDbOlgaElisyutinaMDbRaffaelaCampanaPhDaMargareteFocke-TejklPhDaMirelaCurinPhDaLeylaNamazova-BaranovaMDeJiu-YaoWangMD, PhDfRubyPawankarMD, PhDgMusaKhaitovMDb
　　创建过敏性疾病的科研、科普知识交流平台，为过敏患者提供专业诊断、治疗、预防的共享平台。