Haugaard L, Dahl R, Jacobsen L
Department of Respiratory Diseases, University Hospital of Aarhus, Denmark.
J Allergy Clin Immunol. 1993 Mar;91(3):709-22. doi: 10.1016/0091-6749(93)90190-q.
Seventy-four asthmatic patients allergic to house dust mite were included in a double-blind, controlled study to establish the optimal maintenance dose of a standardized extract of Dermatophagoides pteronyssinus (Der p I) during 24 months of immunotherapy (IT).
The patients were given the following maintenance doses: 19 patients 10,000 standardized quality units (SQ-U) (group 10, 0.7 microgram Der p I), 20 patients 100,000 SQ-U (group 100, 7 micrograms Der p I), 16 patients 300,000 SQ-U (group 300, 21 micrograms Der p I), and 19 control patients (group 0) had no injections. After 24 months bronchial challenge demonstrated a dose-related increased tolerance to Der p I, group 10 (p = 0.003), group 100 (p = 0.0005), group 300 (p = 0.0007), with no change in group 0 (p = 0.6). Patients given IT had a decrease in medication and peak expiratory flow score. In total, 2104 injections were given, and 3.5% were followed by a systemic reaction, defined as a fall 15% or greater in forced expiratory volume in 1 second within 30 minutes. A dose-response relation was demonstrated, with rates of systemic reactions in percent of injections; group 10, 0.56%; group 100, 3.30%; and group 300, 7.10% (p < 0.0001). No anaphylactic reactions occurred, and no late systemic reactions were observed. This study demonstrated a dose dependence of efficacy and side effects of IT in asthmatic patients. We suggest a maintenance dose of 100,000 SQ-U (7 micrograms Der p I) as an appropriate guideline for IT with house dust mite extract.
74名对屋尘螨过敏的哮喘患者被纳入一项双盲对照研究，以确定在24个月的免疫治疗（IT）期间，标准化的柏氏禽刺螨提取物（Der p I）的最佳维持剂量。
患者被给予以下维持剂量：19名患者为10,000标准化质量单位（SQ-U）（第10组，0.7微克Der p I），20名患者为100,000 SQ-U（第100组，7微克Der p I），16名患者为300,000 SQ-U（第300组，21微克Der p I），19名对照患者（第0组）不进行注射。24个月后，支气管激发试验显示对Der p I的耐受性呈剂量相关增加，第10组（p = 0.003），第100组（p = 0.0005），第300组（p = 0.0007），第0组无变化（p = 0.6）。接受IT治疗的患者药物使用量和呼气峰值流速评分降低。总共进行了2104次注射，3.5%的注射后出现全身反应，定义为在30分钟内1秒用力呼气量下降15%或更多。显示出剂量反应关系，全身反应发生率以注射次数的百分比表示；第10组，0.56%；第100组，3.30%；第300组，7.10%（p < 0.0001）。未发生过敏反应，也未观察到迟发性全身反应。本研究证明了IT在哮喘患者中的疗效和副作用存在剂量依赖性。我们建议100,000 SQ-U（7微克Der p I）的维持剂量作为屋尘螨提取物IT的适当指导原则。
