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在环境暴露单元(EEU)中接受评估的受试者中,左西替利嗪和地氯雷他定治疗季节性过敏性鼻炎症状的临床疗效、起效时间及作用持续时间的比较

Comparative clinical efficacy, onset and duration of action of levocetirizine and desloratadine for symptoms of seasonal allergic rhinitis in subjects evaluated in the Environmental Exposure Unit (EEU).

作者信息

Day J H, Briscoe M P, Rafeiro E, Ratz J D

机构信息

Division of Allergy and Immunology, Kingston General Hospital, Kingston, Ontario, Canada.

出版信息

Int J Clin Pract. 2004 Feb;58(2):109-18. doi: 10.1111/j.1368-5031.2004.0117.x.

Abstract

The Environmental Exposure Unit, an indoor pollen challenge system to test anti-allergic medications, was used to compare the onset and duration of action and the efficacy of levocetirizine and desloratadine, two recently developed H1-antagonists. In this double-blind, placebo-controlled, parallel-group study, qualified subjects were randomised to once-daily levocetirizine 5 mg (n = 141), desloratadine 5 mg (n = 140) or placebo (n = 92) and exposed to ragweed pollen on two consecutive days (7 h and 6 h). Symptoms were self-rated every 30 min. On both days, levocetirizine produced a greater improvement in the major symptom complex score (primary efficacy variable) than desloratadine (p = 0.015); both were better than placebo (p < 0.001). Levocetirizine acted earlier (1 h vs. 3 h) and produced greater symptom relief at 24 h than desloratadine (p = 0.003). Levocetirizine also alleviated nasal obstruction better than desloratadine (p = 0.007) on day 1; and better than placebo (p = 0.014) after the second dose on day 2, which was not observed with desloratadine. Levocetirizine and desloratadine were safe and well tolerated.

摘要

环境暴露单元是一种用于测试抗过敏药物的室内花粉激发系统,用于比较最近开发的两种H1拮抗剂左西替利嗪和地氯雷他定的起效时间、作用持续时间和疗效。在这项双盲、安慰剂对照、平行组研究中,符合条件的受试者被随机分为每日一次服用左西替利嗪5毫克(n = 141)、地氯雷他定5毫克(n = 140)或安慰剂(n = 92),并连续两天暴露于豚草花粉(7小时和6小时)。症状每30分钟进行一次自我评估。在这两天中,左西替利嗪在主要症状综合评分(主要疗效变量)方面比地氯雷他定有更大改善(p = 0.015);两者均优于安慰剂(p < 0.001)。左西替利嗪起效更早(1小时对3小时),在24小时时比地氯雷他定产生更大的症状缓解(p = 0.003)。在第1天,左西替利嗪缓解鼻塞的效果也比地氯雷他定更好(p = 0.007);在第2天第二次给药后,左西替利嗪比安慰剂更好(p = 0.014),而地氯雷他定未观察到这种情况。左西替利嗪和地氯雷他定安全且耐受性良好。

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