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螨过敏性鼻炎:如何在变应原特异性免疫治疗试验中评估临床疗效?

Mite-Allergic Rhinitis: How to Evaluate Clinical Efficacy in Allergen-Specific Immunotherapy Trials?

作者信息

Pfaar Oliver, Gerth van Wijk Roy

机构信息

Center for Rhinology and Allergology Wiesbaden, Germany, An den Quellen 10, 65189 Wiesbaden, Germany ; Department of Otorhinolaryngology, Head and Neck Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.

Section of Allergology, Department of Internal Medicine, Erasmus MC, Rotterdam, The Netherlands.

出版信息

Curr Treat Options Allergy. 2015;2(1):1-9. doi: 10.1007/s40521-014-0040-y.

DOI:10.1007/s40521-014-0040-y
PMID:25798370
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4361724/
Abstract

House dust mite (HDM) allergen exposure is the most important cause of perennial allergic rhinitis and/or asthma. Although allergen-specific immunotherapy (AIT) with HDM is well established, published studies have been characterized by substantial heterogeneity in clinical endpoints. Standardization in measuring clinical efficacy is required. Moreover, when designing an AIT trial with HDM allergens, several considerations have to be taken into account. The history of HDM allergy is less clear cut than the typical history of pollen allergy. In addition, clinical features of HDM allergy may differ from those of pollen allergy. Moreover, although not easily measurable, fluctuation in allergen exposure may cause variation in symptom severity and determine the timing of assessment of clinical effects of HDM AIT. Key points 1. A combined symptom and medication score (CSMS) is recommended as standard for the primary endpoint in future house dust mite (HDM) allergen-specific immunotherapy trials. 2. The diagnosis of HDM allergy is based on a carefully taken history in combination with sensitization to HDM allergens. 3. Eye symptoms are less prominent in patients with HDM-induced allergic rhinitis. Nasal symptoms, but not eye symptoms, should be included in the CSMS and in symptom scores as well. 4. As methods to determine allergen exposure vary and the efficacy of environmental control is a matter of debate, a practical approach consists of restraining patients from implementing HDM-reducing measures, such as removing carpets and introducing anti-mite covers, after the start of the study. 5. Efficacy evaluation in the period with the highest exposure to mites is recommended.

摘要

屋尘螨(HDM)过敏原暴露是常年性变应性鼻炎和/或哮喘的最重要病因。尽管使用HDM进行过敏原特异性免疫疗法(AIT)已得到充分确立,但已发表的研究在临床终点方面存在很大异质性。需要对临床疗效测量进行标准化。此外,在设计使用HDM过敏原的AIT试验时,必须考虑几个因素。HDM过敏的病史不如典型的花粉过敏病史明确。此外,HDM过敏的临床特征可能与花粉过敏不同。而且,尽管不易测量,但过敏原暴露的波动可能导致症状严重程度的变化,并决定HDM AIT临床效果评估的时间。要点:1. 建议将症状和药物综合评分(CSMS)作为未来屋尘螨(HDM)过敏原特异性免疫疗法试验主要终点的标准。2. HDM过敏的诊断基于详细的病史以及对HDM过敏原的致敏情况。3. HDM诱发的变应性鼻炎患者眼部症状不那么突出。CSMS和症状评分中应包括鼻部症状,但不包括眼部症状。4. 由于确定过敏原暴露的方法各不相同,且环境控制的效果存在争议,一种实际的方法是在研究开始后限制患者采取减少HDM的措施,如移除地毯和使用防螨套。5. 建议在螨虫暴露最高的时期进行疗效评估。

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J Allergy Clin Immunol. 2015 Mar;135(3):636-43. doi: 10.1016/j.jaci.2014.10.045. Epub 2014 Dec 18.
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Update on house dust mite immunotherapy: are more studies needed?屋尘螨免疫疗法的最新进展:是否需要更多研究?
Curr Opin Allergy Clin Immunol. 2014 Dec;14(6):542-8. doi: 10.1097/ACI.0000000000000104.
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House dust mite sublingual immunotherapy is safe and appears to be effective in moderate, persistent asthma.屋尘螨舌下免疫治疗在中重度持续性哮喘中安全且有效。
Allergy. 2014 Sep;69(9):1181-8. doi: 10.1111/all.12188. Epub 2014 Jul 24.
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Characteristics and management of sublingual allergen immunotherapy in children with allergic rhinitis and asthma induced by house dust mite allergens.尘螨变应原致儿童过敏性鼻炎和哮喘的舌下免疫治疗的特点和管理。
Clin Transl Allergy. 2014 Apr 29;4:15. doi: 10.1186/2045-7022-4-15. eCollection 2014.
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Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper.用于变应性鼻结膜炎变应原免疫治疗试验的临床结局指标标准化的建议:一项 EAACI 立场文件。
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Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis.舌下片剂的屋尘螨变应原提取物在成人过敏性鼻炎中的疗效和安全性。
J Allergy Clin Immunol. 2014 Jun;133(6):1608-14.e6. doi: 10.1016/j.jaci.2013.11.012. Epub 2013 Dec 31.
7
An evidence-based analysis of house dust mite allergen immunotherapy: a call for more rigorous clinical studies.基于证据的室内尘螨变应原免疫治疗分析:呼吁开展更严格的临床研究。
J Allergy Clin Immunol. 2013 Dec;132(6):1322-36. doi: 10.1016/j.jaci.2013.09.004. Epub 2013 Oct 18.
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Allergen immunotherapy for house dust mite: clinical efficacy and immunological mechanisms in allergic rhinitis and asthma.屋尘螨变应原免疫治疗:变应性鼻炎和哮喘的临床疗效和免疫学机制。
Expert Opin Biol Ther. 2013 Nov;13(11):1543-56. doi: 10.1517/14712598.2013.844226. Epub 2013 Oct 8.
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Sublingual immunotherapy in children with allergic rhinoconjunctivitis mono-sensitized to house-dust-mites: a double-blind-placebo-controlled randomised trial.舌下免疫治疗尘螨单致敏变应性鼻结膜炎儿童的双盲安慰剂对照随机试验。
Respir Med. 2013 Sep;107(9):1322-9. doi: 10.1016/j.rmed.2013.06.021. Epub 2013 Jul 23.
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House dust mite sublingual immunotherapy: a double-blind, placebo-controlled study in elderly patients with allergic rhinitis.屋尘螨舌下免疫治疗:老年变应性鼻炎患者的一项双盲、安慰剂对照研究。
Clin Exp Allergy. 2013 Feb;43(2):242-8. doi: 10.1111/cea.12039.