Varney V A, Gaga M, Frew A J, Aber V R, Kay A B, Durham S R
Department of Allergy, Clinical Immunology, National Heart and Lung Institute, Royal Brompton Hospital, London.
BMJ. 1991 Feb 2;302(6771):265-9. doi: 10.1136/bmj.302.6771.265.
To evaluate the efficacy and safety of immunotherapy (hyposensitisation) in patients with severe summer hay fever.
A randomised, double blind, placebo controlled study of a biologically standardised depot grass pollen extract.
Allergy clinic, Royal Brompton and National Heart Hospital, London.
40 adults (mean age 35 years) with a history of severe grass pollen allergy uncontrolled by standard antiallergic drugs. Patients with perennial asthma were specifically excluded.
Patients were randomised to receive either an active preparation (Alutard SQ, a grass pollen (Phleum pratense) extract) or placebo at a rate of two subcutaneous injections a week in increasing doses until a maintenance dose was reached. This maintenance dose was given once a month.
Clinical efficacy was evaluated by symptom and drug diary cards, visual analogue scores during the grass pollen season, and a postseasonal assessment by the patients and a doctor. Conjunctival and skin sensitivity to local allergen provocation was measured before and after eight months of treatment.
There was a highly significant decrease (median Alutard SQ v median placebo (95% confidence interval for difference between medians] in total symptom scores (p=0.001) in the Alutard SQ treated group (360 v 928 (238 to 825]. Significant differences were also found in total drug use (p=0.002, 129 v 627 (178 to 574]. Visual analogue symptom scores were also reduced in the active group (p=0.02, 2.2 v 5.5 (-4.8 to -0.5]. The postseasonal assessment, by either the doctor or the patients, showed a large improvement (p less than 0.001) in favour of Alutard SQ. Provocation tests showed a greater than 10-fold reduction for the active group in immediate conjunctival allergen sensitivity (p=0.001), a 40% decrease in early phase response (p=0.02), and a 57% decrease in the late phase (p=0.001) cutaneous response after intradermal allergen. A total of 523 active injections were given. There was one systemic reaction at 10 minutes after injection, which was rapidly reversed with intramuscular adrenaline. There was one mild delayed urticarial reaction at 2 1/2 hours.
Immunotherapy is effective in patients with severe summer hay fever, but immediate anaphylactic reactions limit its use to specialised centres. Patient selection is extremely important, and chronic perennial asthma should be specifically excluded. As serious reactions occur within minutes a two hour wait for all patients after each injection seems unnecessary.
评估免疫疗法（减敏疗法）对重度夏季花粉症患者的疗效和安全性。
一项关于生物标准化长效草花粉提取物的随机、双盲、安慰剂对照研究。
伦敦皇家布朗普顿和国家心脏医院过敏诊所。
40名成年人（平均年龄35岁），有严重草花粉过敏史，标准抗过敏药物无法控制症状。明确排除常年性哮喘患者。
患者被随机分组，分别接受活性制剂（阿罗格SQ，一种草花粉（早熟禾）提取物）或安慰剂，每周皮下注射两次，剂量逐渐增加，直至达到维持剂量。维持剂量每月注射一次。
通过症状和用药记录卡、花粉季节视觉模拟评分以及患者和医生的季候后评估来评估临床疗效。在治疗8个月前后测量结膜和皮肤对局部过敏原激发的敏感性。
阿罗格SQ治疗组的总症状评分显著降低（阿罗格SQ中位数与安慰剂中位数[中位数差异的95%置信区间]）（p = 0.001）（360对928[238至825]）。总用药量也有显著差异（p = 0.002，129对627[178至574]）。活性组的视觉模拟症状评分也有所降低（p = 0.02，2.2对5.5[-4.8至-0.5]）。医生或患者进行的季候后评估显示，阿罗格SQ组有大幅改善（p < 0.001）。激发试验显示，活性组的即刻结膜过敏原敏感性降低超过10倍（p = 0.001），皮内注射过敏原后的早期反应降低40%（p = 0.02），晚期反应降低57%（p = 0.001）。共进行了523次活性注射。注射后10分钟出现1次全身反应，用肌肉注射肾上腺素后迅速逆转。2个半小时出现1次轻度迟发性荨麻疹反应。
免疫疗法对重度夏季花粉症患者有效，但即刻过敏反应限制了其仅能在专业中心使用。患者选择极为重要，应明确排除慢性常年性哮喘患者。由于严重反应在数分钟内发生，每次注射后让所有患者等待两小时似乎没有必要。
