Bødtger U, Poulsen L K, Jacobi H H, Malling H-J
Allergy Unit, National University Hospital, Copenhagen, Denmark.
Allergy. 2002 Apr;57(4):297-305. doi: 10.1034/j.1398-9995.2002.1o3532.x.
There is only very limited documentation of the efficacy and safety of high-dose subcutaneous birch pollen immunotherapy (IT) in double-blind, placebo-controlled (DBPC) studies. Birch pollen is a major cause of allergic morbidity in northern Europe and in eastern parts of North America.
Thirty-five patients with severe rhinoconjunctivitis (hay fever) to birch pollen were allocated to double-blinded clustered IT with a depot birch pollen extract (Betula verrucosa) or placebo injections. Seven patients in each group had concomitant self-reported seasonal asthma. Treatment was conducted as a clustered regimen and was performed in a specialist unit. Symptom scores from nose, eyes, and lungs, and use of oral and topical antihistamines, beta-2-agonists, and oral corticosteroids were recorded daily during the season of 2000. Sensitivity to allergen provocation in skin, conjunctiva, and nasal mucosa was measured before and after 10 months of treatment. Post-seasonal assessment of symptom severity was performed using a simple questionnaire.
IT reduced the symptom score for both rhinoconjunctivitis and asthma (P-values < 0.05), total medication score (P < 0.02) and use of oral antihistamines (P < 0.01). IT reduced specific conjunctival sensitivity (P < 0.05), skin prick test, and especially cutaneous late-phase response diameters (P < 0.00001), and increased general well-being on post-seasonal evaluation (P < 0.01). IT was safe, with side-effects at the same level as placebo.
High-dose, subcutaneous IT is efficacious and safe in patients with severe birch pollen rhinoconjunctivitis and asthma.
在双盲、安慰剂对照（DBPC）研究中，关于高剂量皮下注射桦树花粉免疫疗法（IT）的疗效和安全性的文献非常有限。桦树花粉是北欧和北美东部地区过敏性疾病发病的主要原因。
35例对桦树花粉严重鼻结膜炎（花粉症）患者被分配至接受双盲分组IT治疗，使用长效桦树花粉提取物（疣桦）或安慰剂注射。每组7例患者伴有自我报告的季节性哮喘。治疗采用分组方案，在专科单位进行。在2000年发病季节期间，每天记录鼻、眼和肺部的症状评分，以及口服和局部使用抗组胺药、β-2激动剂和口服皮质类固醇的使用情况。在治疗10个月前后，测量皮肤、结膜和鼻粘膜对过敏原激发的敏感性。使用简单问卷对季节后症状严重程度进行评估。
IT降低了鼻结膜炎和哮喘的症状评分（P值<0.05）、总用药评分（P<0.02）和口服抗组胺药的使用（P<0.01）。IT降低了特异性结膜敏感性（P<0.05）、皮肤点刺试验，尤其是皮肤迟发相反应直径（P<0.00001），并在季节后评估中提高了总体健康状况（P<0.01）。IT是安全的，副作用与安慰剂处于同一水平。
高剂量皮下IT对严重桦树花粉鼻结膜炎和哮喘患者有效且安全。
