原標(biāo)題：用 Alt a 1免疫治療的雙盲、隨機(jī)、安慰劑對照試驗(yàn)
　?、俦尘?與其他變應(yīng)原提取物相比，應(yīng)用真菌變應(yīng)原提取物進(jìn)行特異性免疫治療的有效性和安全性的相關(guān)研究較少，對真菌鏈格孢霉主要變應(yīng)原Alt a1的研究資料也未見報(bào)道。②目的:探討2種不同劑量Alt a1皮下免疫治療鼻結(jié)膜炎的療效和安全性。③方法:我們對年齡在12 - 65歲的過敏性鼻結(jié)膜炎合并或不合并哮喘的患者進(jìn)行多中心、隨機(jī)、雙盲、安慰劑對照試驗(yàn)，同時皮下注射Alt a1。包括三組:安慰劑組和接受每劑為0.2或0.37毫克Alt a 1的兩組治療組。主要終點(diǎn)為癥狀與用藥評分的結(jié)合。次要終點(diǎn)為皮膚反應(yīng)性、對血清Alt a1 特異性IgE和IgG4水平的影響。記錄的不良反應(yīng)按照世界過敏組織的標(biāo)準(zhǔn)進(jìn)行分級。④結(jié)果:治療12個月時，與安慰劑相比，0.37 mg劑量的Alt a1的綜合癥狀和藥物評分顯著降低。與安慰劑組相比，兩組患者的皮膚反應(yīng)性和IgE水平降低，IgG4水平升高。與安慰劑組相比，兩個治療組的安全性相似。無嚴(yán)重藥物不良反應(yīng)報(bào)告。⑤結(jié)論:Alt a1免疫治療有效、安全，僅治療1年，就可減少鼻結(jié)膜炎的癥狀及藥物使用量。臨床益處與降低皮膚反應(yīng)活性和特異性IgE水平下降以及特異性IgG4水平增加有關(guān)。(J Allergy Clin Immunol 2019;144:216-23)
延伸閱讀
JACI                               
Double-blind,  randomized,  placebo-controlled trial of allergen-specific  immunotherapy  with  the major allergen Alt a 1
https://doi.org/10.1016/j.jaci.2019.02.029
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.)
All Author:
Ana Isabel Tabar, MD, PhD, Luis Prieto, MD, PhD, Pilar Alba, MD,Antonio Nieto, MD, PhD,Mercedes Rodr'?guez, MD,
Miguel Torrecillas, MD,Beatriz Huertas, MD,Elisa Go'mez, MD, PhD, Francisco Javier Ferna'ndez, MD, PhD
Miguel Blanca, MD, PhD, David Rodr'?guez, PhD, and Ricardo Palacios, PhD  
Pamplona, Valencia, Madrid, Albacete, Ciudad Real, Alicante, and Malaga, Spain
　　創(chuàng)建過敏性疾病的科研、科普知識交流平臺，為過敏患者提供專業(yè)診斷、治療、預(yù)防的共享平臺。