Preventive symptomatic immunotherapy versus placebo in seasonal rhinitis due to grasses in children and to Parietaria in adult patients.

Allergie et immunologie Pub Date : 2000-06-01
C Troise, D Bignardi, P Modena, C Pissacroia, F Di Berardino
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Abstract

Background: EPD is the only preventive symptomatic immunotherapy available on the market and approved by competent bodies. Recent double-blind placebo controlled (DBPC) studies have demonstrated its efficacy in seasonal and perennial rhinitis. The aim of the study was to confirm the efficacy and safety of a single dose of immunotherapy administered six-eight weeks before the pollen season.

Methods: Two simultaneous DBPC trials were carried out. The first consisted of 20 children with grass-pollen seasonal rhinitis (Bollate-Milano, Italy) and the second included 30 adult patients with Parietaria-pollen seasonal rhinitis (Genova, Italy). EPD was administered only to the active groups.

Results: A significant difference in favour of the active treatment groups was seen in oral antihistamine use (p < 0.05) during the peak pollen seasons. Throughout the pollen seasons, rhinoconjunctivitis scores for the two groups in both studies presented no significant difference, even if the values were lower in the active groups.

Conclusions: The oral antihistamine reduction, observed in the active groups during the seasonal period, supports the efficacy of this treatment, although a significant improvement in the rhinoconjunctivitis symptoms was not observed, probably due to the use of oral antihistamine in the placebo groups. The overall profile of the EPD was good. It could be particularly suited for short term therapy to prevent seasonal symptoms in allergic patients.

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预防对症免疫疗法与安慰剂在儿童草性季节性鼻炎和成人鼻咽炎患者中的疗效比较。
背景:EPD是市场上唯一一种经主管机构批准的预防性对症免疫疗法。最近的双盲安慰剂对照(DBPC)研究已经证明了它对季节性和常年性鼻炎的疗效。该研究的目的是确认在花粉季节前6 - 8周进行单剂量免疫治疗的有效性和安全性。方法:同时进行两项DBPC试验。第一组包括20例患有草花粉季节性鼻炎的儿童(bolate - milano,意大利),第二组包括30例患有草花粉季节性鼻炎的成人(Genova,意大利)。仅给活跃组注射EPD。结果:在花粉高峰季节,积极治疗组口服抗组胺药的使用差异有统计学意义(p < 0.05)。在整个花粉季节,两组的鼻结膜炎评分在两项研究中均无显著差异,即使活跃组的数值较低。结论:在季节性活动组中观察到口服抗组胺减少,支持这种治疗的疗效,尽管未观察到鼻结膜炎症状的显着改善,可能是由于安慰剂组使用了口服抗组胺。环保署的整体情况良好。它可能特别适合短期治疗,以防止过敏患者的季节性症状。
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