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高剂量西替利嗪治疗胆碱能性荨麻疹的双盲交叉研究。

Double-blind crossover study of high-dose cetirizine in cholinergic urticaria.

作者信息

Zuberbier T, Münzberger C, Haustein U, Trippas E, Burtin B, Mariz S D, Henz B M

机构信息

Department of Dermatology, Virchow Klinikum, Humboldt University, Berlin, Germany.

出版信息

Dermatology. 1996;193(4):324-7. doi: 10.1159/000246281.

Abstract

BACKGROUND

Cholinergic urticaria does not respond well to treatment with conventional antihistamines and is difficult to study because of its highly variable clinical expression which depends on the presence of eliciting factors.

OBJECTIVE

We have therefore designed a double-blind, crossover, placebo-controlled trial, with a 3-week treatment period using either 20 mg/day of cetirizine or placebo.

METHODS AND RESULTS

Presence of eliciting factors and symptoms were scored daily on a diary card by the patient, with a scale from 0 to 3 for erythema, wheals and pruritus. Statistical analysis was done on 11 evaluable patients during the last 2 weeks of each treatment period (to allow for 1 week of washout) and only for days when eliciting factors were present. Compared to placebo, cetirizine caused a statistically significant reduction of wheals (p = 0.015), erythema (p = 0.033), pruritus (p = 0.006) and all symptoms (p = 0.013). No adverse events were observed.

CONCLUSION

These data show a high efficacy of cetirizine at twice its normally recommended dose which may be related to the specific antiallergic effects of this newer-generation antihistamine.

摘要

背景

胆碱能性荨麻疹对传统抗组胺药治疗反应不佳,且由于其临床症状高度可变,取决于诱发因素的存在,因此难以研究。

目的

因此,我们设计了一项双盲、交叉、安慰剂对照试验,治疗期为3周,使用20毫克/天的西替利嗪或安慰剂。

方法与结果

患者每天在日记卡上对诱发因素和症状进行评分,红斑、风团和瘙痒的评分范围为0至3。在每个治疗期的最后2周(留出1周的洗脱期),仅对存在诱发因素的日子,对11名可评估患者进行统计分析。与安慰剂相比,西替利嗪使风团(p = 0.015)、红斑(p = 0.033)、瘙痒(p = 0.006)和所有症状(p = 0.013)在统计学上显著减轻。未观察到不良事件。

结论

这些数据表明,西替利嗪在其正常推荐剂量的两倍时具有高效性,这可能与其作为新一代抗组胺药的特定抗过敏作用有关。

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