原标题：用 Alt a 1免疫治疗的双盲、随机、安慰剂对照试验
①背景:与其他变应原提取物相比，应用真菌变应原提取物进行特异性免疫治疗的有效性和安全性的相关研究较少，对真菌链格孢霉主要变应原Alt a1的研究资料也未见报道。②目的:探讨2种不同剂量Alt a1皮下免疫治疗鼻结膜炎的疗效和安全性。③方法:我们对年龄在12 - 65岁的过敏性鼻结膜炎合并或不合并哮喘的患者进行多中心、随机、双盲、安慰剂对照试验，同时皮下注射Alt a1。包括三组:安慰剂组和接受每剂为0.2或0.37毫克Alt a 1的两组治疗组。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、对血清Alt a1 特异性IgE和IgG4水平的影响。记录的不良反应按照世界过敏组织的标准进行分级。④结果:治疗12个月时，与安慰剂相比，0.37 mg剂量的Alt a1的综合症状和药物评分显著降低。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，两个治疗组的安全性相似。无严重药物不良反应报告。⑤结论:Alt a1免疫治疗有效、安全，仅治疗1年，就可减少鼻结膜炎的症状及药物使用量。临床益处与降低皮肤反应活性和特异性IgE水平下降以及特异性IgG4水平增加有关。(J Allergy Clin Immunol 2019;144:216-23)
Double-blind, randomized, placebo-controlled trial of allergen-specific immunotherapy with the major allergen Alt a 1
Background: 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.
Objectives: 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.
Method: 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 mg 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.
Results: There were significant reductions in the combined symptom and medication score for the 0.37-mg 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.
Conclusion: 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. (J Allergy Clin Immunol 2019;144:216-23.)
Ana Isabel Tabar, MD, PhD, Luis Prieto, MD, PhD, Pilar Alba, MD,Antonio Nieto, MD, PhD,Mercedes Rodr'ıguez, MD,
Miguel Torrecillas, MD,Beatriz Huertas, MD,Elisa Go'mez, MD, PhD, Francisco Javier Ferna'ndez, MD, PhD
Miguel Blanca, MD, PhD, David Rodr'ıguez, PhD, and Ricardo Palacios, PhD
Pamplona, Valencia, Madrid, Albacete, Ciudad Real, Alicante, and Malaga, Spain