Nielsen L, Johnsen C R, Mosbech H, Poulsen L K, Malling H J
Medical Department, National University Hospital, Copenhagen, Denmark.
J Allergy Clin Immunol. 1996 Jun;97(6):1207-13. doi: 10.1016/s0091-6749(96)70186-0.
Specific immunotherapy treatment in allergic diseases involves a risk of systemic side effects. A double-blind, placebo-controlled study was performed in 45 patients allergic to pollen to determine whether pretreatment with loratadine could reduce the number and severity of systemic reactions during the dose-increase phase of cluster immunotherapy.
The patients received cluster immunotherapy with a standardized birch (Betula verrucosa) or grass (Phleum pratense) pollen extract adsorbed to aluminum hydroxide. The immunotherapy schedule involved seven visits and 14 injections to reach a maintenance dose of 100,000 standardized quality units. Loratadine, 10 mg, or placebo tablets were administered 2 hours before the first injection at each visit.
A total of 720 injections were given (309 injections in 21 patients receiving loratadine and 411 injections in 24 patients receiving placebo). The median numbers of injections to reach maintenance dose were 15 (range, 14 to 18) in the loratadine group and 16 (range, 14 to 23) in the placebo group (p = 0.037). The numbers of patients with systemic reactions were seven (33%) and 19 (79%) in the loratadine and placebo groups, respectively (p = 0.002). Twenty-five reductions caused by systemic reactions were observed in the placebo group in contrast to nine in the loratadine group (p = 0.047). No life-threatening systemic reactions were observed in either group. Systemic reactions were, however, more severe in the placebo group, mainly because of a significantly higher incidence of urticaria (10 vs 1, p = 0.022).
Pretreatment with loratadine seems to reduce both the number and severity of systemic reactions in specific cluster immunotherapy.
过敏性疾病的特异性免疫疗法存在全身副作用风险。对45名花粉过敏患者进行了一项双盲、安慰剂对照研究，以确定在集群免疫疗法剂量增加阶段，用氯雷他定预处理是否能减少全身反应的数量和严重程度。
患者接受吸附于氢氧化铝的标准化桦树（疣桦）或禾本科（梯牧草）花粉提取物的集群免疫疗法。免疫疗法方案包括七次就诊和14次注射，以达到100,000标准化质量单位的维持剂量。每次就诊时，在首次注射前2小时给予10毫克氯雷他定或安慰剂片剂。
共进行了720次注射（21名接受氯雷他定治疗的患者注射309次，24名接受安慰剂治疗的患者注射411次）。氯雷他定组达到维持剂量的注射次数中位数为15次（范围14至18次），安慰剂组为16次（范围14至23次）（p = 0.037）。氯雷他定组和安慰剂组发生全身反应的患者人数分别为7名（33%）和19名（79%）（p = 0.002）。安慰剂组观察到25次因全身反应导致的剂量减少，而氯雷他定组为9次（p = 0.047）。两组均未观察到危及生命的全身反应。然而，安慰剂组的全身反应更严重，主要是因为荨麻疹的发生率显著更高（10例对1例，p = 0.022）。
氯雷他定预处理似乎能减少特异性集群免疫疗法中全身反应的数量和严重程度。
