皮下变应原免疫疗法治疗哮喘：一项使用标准化疫苗的随机、双盲、安慰剂对照研究。
Subcutaneous allergen immunotherapy for asthma: A randomized, double-blind, placebo-controlled study with a standardized vaccine.
作者信息
Castro-Almarales Raúl Lázaro, Ronquillo-Díaz Mercedes, Álvarez-Castelló Mirta, Rodríguez-Canosa José, González-León Mayda, Enríquez-Domínguez Irene, Navarro-Viltre Bárbara Ivonne, Mateo-Morejón Maytee, Oliva-Díaz Yunia, Ramírez-González Wendy, Cox Linda, Labrada-Rosado Alexis
机构信息
Second Degree Specialist in Allergy and Integral General Medicine, Master in Transmissible Diseases, Auxiliary Professor, "General Calixto García" University Hospital, Havana University of Medical Science. Auxiliary Researcher, National Center of Bioproducts, Bejucal, Mayabeque, Cuba.
Second Degree Specialist in Allergy, Master in Occupational Health, Auxiliary Professor, "General Calixto García" University Hospital, Allergy and Immunology Service, Havana University of Medical Science, Cuba.
出版信息
World Allergy Organ J. 2020 Apr 10;13(4):100098. doi: 10.1016/j.waojou.2020.100098. eCollection 2020 Apr.
BACKGROUND
Sensitization to () is very frequent in the tropics, and particularly in Cuba, being a significant cause of allergic asthma. Allergen immunotherapy (AIT) with can be a therapeutic option, however, placebo-controlled clinical trials have not been reported.
OBJECTIVE
To assess the therapeutic effect and safety of AIT for asthma using a standardized allergen vaccine of by subcutaneous route, in allergic asthmatic patients exposed and sensitized to this mite species.
METHODS
A double-blind, placebo-controlled Phase II trial was conducted in 35 adults (18 with treatment and 17 with placebo), with mild to moderate asthma, predominantly sensitized to . AIT was administered subcutaneously in increasing doses from 4 to 6000 Biological Units using a locally manufactured standardized extract (BIOCEN, Cuba). Patient assessment was performed using symptom-medication score (SMS), peak expiratory flow and skin reactivity relative to Histamine as measured by skin prick test (SPT).
RESULTS
The 12-month treatment achieved a significant (p < 0.001) decrease of SMS. Symptom score showed only 41% (CI: 26-61) of placebo values, whereas medication was 34.5% (22.4%-63.3%). Treatment was regarded clinically effective in 67% of patients (OR 32; 95%CI: 17 to 102). The effect size on symptoms and medication was higher than has been reported with equivalent allergen dosages of and in Cuban asthmatic patients. Skin reactivity to was also significantly reduced (p = 0.0001), increasing 148-fold the allergen threshold to elicit a positive skin test. This desensitization effect was specific to and did not modify the reactivity to . The change of specific skin reactivity was significantly (p < 0.05) correlated to clinical improvement. All adverse events were local with a frequency of 2.4% of injections.
CONCLUSIONS
Subcutaneous AIT with was effective and safe in asthmatic adults exposed and sensitized to this mite species in a tropical environment.
TRIAL REGISTRATION
Cuban Public Registry of Clinical Trials: RPCEC00000026 (WHO International Clinical Trial Registry Platform ICTRP).
背景
对（）过敏在热带地区非常常见，在古巴尤为如此，是过敏性哮喘的重要病因。使用（）进行变应原免疫疗法（AIT）可能是一种治疗选择，然而，尚未有安慰剂对照的临床试验报道。
目的
评估在暴露于并对该螨种致敏的过敏性哮喘患者中，通过皮下途径使用标准化变应原疫苗进行AIT治疗哮喘的疗效和安全性。
方法
对35名成年人（18名接受治疗，17名接受安慰剂）进行了一项双盲、安慰剂对照的II期试验，这些患者患有轻度至中度哮喘，主要对（）致敏。使用古巴当地生产的标准化提取物（BIOCEN），以4至6000生物单位的递增剂量皮下注射AIT。使用症状-药物评分（SMS）、呼气峰值流速以及通过皮肤点刺试验（SPT）测量的相对于组胺的皮肤反应性对患者进行评估。
结果
12个月的治疗使SMS显著降低（p < 0.001）。症状评分仅为安慰剂值的41%（CI：26 - 61），而药物使用量为34.5%（22.4% - 63.3%）。67%的患者临床治疗有效（OR 32；95%CI：17至102）。对症状和药物使用的效应大小高于古巴哮喘患者使用等量（）和（）变应原剂量时所报道的效应大小。对（）的皮肤反应性也显著降低（p = 0.0001），使引发阳性皮肤试验的变应原阈值提高了148倍。这种脱敏效应是（）特有的，并未改变对（）的反应性。特异性皮肤反应性的变化与临床改善显著相关（p < 0.0）。所有不良事件均为局部性，注射频率为2.4%。
结论
在热带环境中，对暴露于并对该螨种致敏的成年哮喘患者，皮下注射（）进行AIT是有效且安全的。
试验注册
古巴临床试验公共注册库：RPCEC00000026（世界卫生组织国际临床试验注册平台ICTRP）
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