Siebenhaar Frank, Degener Franziska, Zuberbier Torsten, Martus Peter, Maurer Marcus
Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany.
J Allergy Clin Immunol. 2009 Mar;123(3):672-9. doi: 10.1016/j.jaci.2008.12.008. Epub 2009 Feb 6.
Increased dosing of nonsedating antihistamines is recommended by the current European Academy of Allergology and Clinical Immunology/Global Allergy and Asthma European Network/European Dermatology Forum guidelines on patients with acquired cold urticaria (ACU) who do not respond satisfactorily to the standard dose. Prospective data supporting this recommendation are scant.
We sought to assess the effects of 5 and 20 mg of desloratadine and placebo on cold-induced urticarial reactions in patients with ACU.
In this prospective, randomized, double-blind, 3-way crossover trial, patients with ACU (n = 30) received placebo, 5 mg of desloratadine, and 20 mg of desloratadine every day each for 7 days separated by 14-day washout periods. At the end of each treatment, patients underwent cold provocation with the TempTest 2.0/2.1 system, and urticarial reactions were assessed by using digital 3-dimensional time-lapse photography and thermography; the critical temperature threshold (CTT) and critical stimulation time threshold (CSTT) were measured. Adverse events (AEs) reported during the study were assessed.
Compared with placebo, 7 days of desloratadine at 5 and 20 mg/d significantly reduced the volume of cold-induced wheals and areas of hyperthermic skin and improved CTT and CSTT results. Desloratadine at 20 mg/d significantly reduced cold-induced wheal volume and CTT and CSTT values versus desloratadine at 5 mg/d. Desloratadine was well tolerated, with no increased rate of somnolence or other AEs with 20 mg of desloratadine.
Desloratadine at standard and high doses significantly improved objective signs of ACU provoked by cold exposure. Desloratadine at 4 times the standard dose significantly reduced ACU lesion severity versus 5 mg of desloratadine without an increase in AEs. This study supports current guidelines that increased desloratadine dosing might benefit patients with urticaria who do not respond to standard doses.
欧洲变态反应和临床免疫学会/全球变态反应和哮喘欧洲网络/欧洲皮肤病学论坛现行指南建议，对于标准剂量治疗效果不佳的获得性寒冷性荨麻疹（ACU）患者，增加非镇静性抗组胺药的剂量。支持这一建议的前瞻性数据很少。
我们试图评估5毫克和20毫克地氯雷他定及安慰剂对ACU患者冷诱导性荨麻疹反应的影响。
在这项前瞻性、随机、双盲、三向交叉试验中，ACU患者（n = 30）分别接受安慰剂、5毫克地氯雷他定和20毫克地氯雷他定治疗，每天一次，各治疗7天，中间间隔14天的洗脱期。每次治疗结束时，患者使用TempTest 2.0/2.1系统进行冷激发试验，并通过数字三维延时摄影和热成像评估荨麻疹反应；测量临界温度阈值（CTT）和临界刺激时间阈值（CSTT）。评估研究期间报告的不良事件（AE）。
与安慰剂相比，5毫克/天和20毫克/天的地氯雷他定治疗7天可显著减少冷诱导风团的体积和皮肤高温区域，并改善CTT和CSTT结果。与5毫克/天的地氯雷他定相比，20毫克/天的地氯雷他定可显著减少冷诱导风团体积以及CTT和CSTT值。地氯雷他定耐受性良好，20毫克地氯雷他定组的嗜睡或其他不良事件发生率没有增加。
标准剂量和高剂量的地氯雷他定可显著改善冷暴露诱发的ACU的客观体征。与5毫克地氯雷他定相比，4倍标准剂量的地氯雷他定可显著降低ACU皮损严重程度，且不良事件没有增加。本研究支持现行指南，即增加地氯雷他定剂量可能使对标准剂量无反应的荨麻疹患者受益。
