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西替利嗪每日10毫克与非索非那定每日120毫克治疗季节性变应性鼻炎症状的疗效与安全性对照比较。

Controlled comparison of the efficacy and safety of cetirizine 10 mg o.d. and fexofenadine 120 mg o.d. in reducing symptoms of seasonal allergic rhinitis.

作者信息

Horak F, Stübner P, Zieglmayer R, Kavina A, De Vos C, Burtin B, Donnelly F

机构信息

ENT Clinic, University of Vienna, Austria.

出版信息

Int Arch Allergy Immunol. 2001 May;125(1):73-9. doi: 10.1159/000053799.

DOI:10.1159/000053799
PMID:11385291
Abstract

BACKGROUND

The efficacy, onset and duration of action and safety of cetirizine 10 mg o.d., fexofenadine 120 mg o.d., and placebo were compared in this investigator-blinded, crossover study involving the use of the Vienna Challenge Chamber.

METHODS

40 volunteers with seasonal allergic rhinitis were exposed to a controlled grass pollen concentration for 6 h on 2 consecutive days. Subjective symptoms and objective measurements were recorded during the allergen exposure periods.

RESULTS

Both active medications were significantly more effective than placebo and had a comparable onset of action in alleviating the symptoms of seasonal allergic rhinitis. The efficacy of both active drugs was comparable for the first 4 h after administration of the drugs on day 1 and day 2. However from 22 to 24 h after the first dose cetirizine was significantly superior to fexofenadine for the major symptom complex score and for sneezing. Concerning the total symptom complex score at day 2 fexofenadine could not reach superiority to placebo. No serious adverse events were reported.

CONCLUSIONS

Cetirizine and fexofenadine were significantly better than placebo, also in reducing the symptom of nasal congestion. However cetirizine appears to have a longer duration of action than fexofenadine.

摘要

背景

在这项采用维也纳激发试验箱的研究者设盲交叉研究中,比较了每日一次口服10毫克西替利嗪、每日一次口服120毫克非索非那定和安慰剂的疗效、起效时间、作用持续时间及安全性。

方法

40名季节性变应性鼻炎志愿者连续两天暴露于受控的草花粉浓度下6小时。在过敏原暴露期间记录主观症状和客观测量结果。

结果

两种活性药物均比安慰剂显著更有效,且在缓解季节性变应性鼻炎症状方面起效时间相当。在第1天和第2天给药后的前4小时,两种活性药物的疗效相当。然而,在首次给药后22至24小时,西替利嗪在主要症状综合评分和打喷嚏方面显著优于非索非那定。关于第2天的总症状综合评分,非索非那定未显示优于安慰剂。未报告严重不良事件。

结论

西替利嗪和非索非那定在减轻鼻塞症状方面也显著优于安慰剂。然而,西替利嗪的作用持续时间似乎比非索非那定更长。

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