原標(biāo)題：過敏原提取物用于體內(nèi)診斷和治療：還有未來(lái)嗎
　　目前，體內(nèi)過敏診斷和過敏原特異性免疫治療(allergen-specific immuntreatment, AIT)仍以天然過敏原來(lái)源提取的過敏原提取物為基礎(chǔ)。一些分析天然過敏原提取物成分的研究顯示，天然過敏原提取物的質(zhì)量存在嚴(yán)重問題，如存在未明確的非過敏原物質(zhì)、污染物，以及單個(gè)過敏原的含量和生物活性變化較大。盡管先進(jìn)的分析技術(shù)越來(lái)越多，但這些問題是無(wú)法克服的，因?yàn)樗鼈兪沁^敏原來(lái)源和提取方法所固有的。針對(duì)天然過敏原提取物的體外過敏診斷問題，通過對(duì)純凈度和生物活性進(jìn)行定義的重組過敏原分子的應(yīng)用，已在很大程度上克服了這些問題。然而，過敏原制劑在體內(nèi)用于診斷和治療還沒有取得任何進(jìn)展。目前尚無(wú)臨床研究對(duì)用于體內(nèi)過敏診斷的過敏原提取物進(jìn)行安全性、敏感性和特異性的記錄。只有非常少的治療性過敏原提取物進(jìn)行了最先進(jìn)的臨床研究，為安全性和有效性提供證據(jù)。在這篇文章中，我們討論了基于天然過敏原提取物的產(chǎn)品質(zhì)量不一致的問題，并分享了我們的觀察結(jié)果，即大多數(shù)可用于體內(nèi)診斷的產(chǎn)品和AIT不符合國(guó)際藥品標(biāo)準(zhǔn)。我們認(rèn)為，通過定義重組產(chǎn)生的過敏原分子和/或其混合物來(lái)替代天然過敏原提取物，可能是保證未來(lái)臨床醫(yī)生提供最先進(jìn)的藥物產(chǎn)品用于過敏患者的體內(nèi)診斷和治療的唯一途徑。
　　延伸閱讀
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
　　創(chuàng)建過敏性疾病的科研、科普知識(shí)交流平臺(tái)，為過敏患者提供專業(yè)診斷、治療、預(yù)防的共享平臺(tái)。