Allergy Unit, IBIMA-Regional University Hospital of Málaga, UMA, Malaga, Spain.
Allergy Unit, Infanta Leonor University Hospital, Madrid, Spain.
Allergy. 2018 Apr;73(4):905-915. doi: 10.1111/all.13350. Epub 2017 Nov 28.
Allergen immunotherapy has been shown to be an effective treatment for local allergic rhinitis (LAR) to house dust mites. Studies with pollen allergen immunotherapy are limited to observational studies. The aim of this study was to evaluate the clinical efficacy and safety of Phleum pratense subcutaneous immunotherapy (Phl-SCIT) in LAR.
In a randomized double-blind placebo-controlled study, 56 patients with moderate-severe LAR to grass pollen received Phl-SCIT with a depigmented polymerized pollen vaccine or placebo for the first year, and Phl-SCIT the second one. The blind was maintained throughout the study. Primary outcome was combined symptom medication score (CSMS) during grass pollen season (GPS). Secondary clinical outcomes included organ-specific symptoms, medication-free days, rhinitis severity and asthma control. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), nasal allergen provocation test (NAPT), skin testing, serum levels of specific IgG4 and specific IgE and safety were also evaluated.
Subcutaneous immunotherapy (SCIT) had a short-term and sustained effect with significant improvements of all primary and secondary clinical outcomes and RQLQ score. SCIT significantly increased serum sIgG4 levels and allergen tolerance, from the 6th to 24th months of treatment. At the end of the study, 83% of patients treated with ≥6 months of SCIT tolerated a concentration of P. pratense over 50 times higher than baseline, and 56% gave a negative NAPT. SCIT was well tolerated; six mild local reactions occurred, and there were no serious adverse events related to the study medication.
Subcutaneous immunotherapy with depigmented polymerized allergen extracts is a safe and clinically effective treatment for LAR to P. pratense.
过敏原免疫疗法已被证明是治疗屋尘螨引起的局部过敏性鼻炎（LAR）的有效方法。花粉过敏原免疫疗法的研究仅限于观察性研究。本研究旨在评估豚草皮下免疫疗法（Phl-SCIT）治疗 LAR 的临床疗效和安全性。
在一项随机、双盲、安慰剂对照研究中，56 例中度至重度对草花粉过敏的患者在第一年接受去色素聚合物花粉疫苗或安慰剂的 Phl-SCIT 治疗，第二年接受 Phl-SCIT 治疗。整个研究过程中保持盲法。主要结局是草花粉季节（GPS）期间的综合症状药物评分（CSMS）。次要临床结局包括器官特异性症状、无药物天数、鼻炎严重程度和哮喘控制。还评估了鼻结膜炎生活质量问卷（RQLQ）、鼻过敏原激发试验（NAPT）、皮肤试验、特异性 IgG4 和特异性 IgE 血清水平以及安全性。
皮下免疫疗法（SCIT）具有短期和持续的效果，所有主要和次要临床结局以及 RQLQ 评分均有显著改善。SCIT 显著增加了血清 sIgG4 水平和过敏原耐受性，从治疗的第 6 个月到第 24 个月。研究结束时，83%接受≥6 个月 SCIT 治疗的患者能够耐受比基线高 50 倍以上的豚草浓度，56%的患者 NAPT 结果为阴性。SCIT 耐受性良好；发生 6 例轻度局部反应，无与研究药物相关的严重不良事件。
去色素聚合物过敏原提取物的皮下免疫疗法是治疗豚草引起的 LAR 的一种安全且有效的治疗方法。
