原标题：用主要变应原Alt a 1进行变应原特异性免疫治疗的双盲、随机、安慰剂对照试验
①与用其他变应原提取物进行特异性免疫治疗相比，用真菌变应原提取物进行免疫治疗的有效性和安全性研究较少，对交链孢霉主要变应原Alt a1的研究也未见报道。②我们试图评估2种不同剂量的Alt a1皮下免疫治疗由链格孢引起的鼻结膜炎的疗效和安全性。③我们进行了一项多中心、随机、双盲、安慰剂对照试验，对年龄在12至65岁之间的过敏性鼻结膜炎合并或不合并哮喘的患者进行皮下注射Alt a1。三组包括:安慰剂组和每剂接受0.2或0.37μg Alt 1的两组治疗组治疗。主要终点为症状与用药评分的结合。次要终点为皮肤反应性、针对Alt a1的血清IgE和IgG4水平的变化。不良反应的记录按照世界过敏组织的标准进行分级。④与安慰剂相比，在12个月的治疗后，0.37 -μg剂量的Alt 1治疗组的症状和药物结合评分有显著减少。与安慰剂组相比，两组患者的皮肤反应性和IgE水平降低，IgG4水平升高。与安慰剂组相比，两治疗组的安全性相似。无严重药物不良反应报告。⑤ Alt a1免疫治疗是有效和安全的，仅经过1年的治疗，鼻结膜炎的症状和药物需要量均减少。临床疗效与皮肤反应性和特异性IgE水平的降低以及特异性IgG4水平的增加有关。
Double-blind, randomized, placebo-controlled trial of allergen-specific immunotherapy with the major allergen Alt a 1
There have been few studies conducted on the efficacy and safety of specific immunotherapy with allergen extracts of fungi compared with other allergen extracts, and there are no data on the major allergen Alt a 1 of the fungus Alternaria alternata.
We sought to evaluate the efficacy and safety of subcutaneous immunotherapy with 2 different doses of Alt a 1 in patients with rhinoconjunctivitis caused by sensitization to A alternata.
We performed a multicenter, randomized, double-blind, placebo-controlled trial with Alt a 1 administered subcutaneously in patients with allergic rhinoconjunctivitis with or without controlled asthma aged 12 to 65 years. Three groups were included: the placebo group and active groups receiving 0.2 or 0.37 μg of Alt a 1 per dose. The main end point was the combined symptom and medication score. Secondary end points were cutaneous reactivity and serum IgE and IgG4 levels to Alt a 1. Recorded adverse reactions were graded according to World Allergy Organization criteria.
There were significant reductions in the combined symptom and medication score for the 0.37-μg dose of Alt a 1 compared with placebo at 12 months of treatment. Reduced cutaneous reactivity and IgE levels, together with increased IgG4 levels, were demonstrated for the 2 active groups versus the placebo group. A similar safety profile was found for both active groups compared with the placebo group. No serious adverse drug reactions were reported.
Immunotherapy with Alt a 1 was efficacious and safe, reducing the symptoms and medication consumption associated with rhinoconjunctivitis after only 1 year of treatment. The clinical benefits were associated with reduced skin reactivity and specific IgE levels and increased IgG4 levels.
Ana Isabel Tabar Luis Prieto Pilar Alba Antonio Nieto Miguel Torrecillas
Mercedes Rodríguez Beatriz Huertas Elisa Gómez Francisco Javier Fernández Ricardo Palacios Miguel Blanca David Rodríguez
xMartin Lloyd HibberdSearch for articles by this authorAffiliations
· Genome Institute of Singapore, Agency for Science, Technology and Research Singapore, Singapore