Kruszewski Jerzy, Kłos Krzysztof, Sułek Kazimierz
Department of Infectious Diseases and Allergology, Military Institute of the Heath Service in Warsaw, Central Clinical Hospital of the Ministry of National Defence.
Pol Merkur Lekarski. 2006 Nov;21(125):443-8.
The aim of the study was to compare the effect of inhibition skin reactivity after administration of single dose administration of various second generation antihistamines in the healthy people group.
Forty two healthy subjects (aged 22+/-18 years) were randomized into seven groups which received orally: cetirizine 10 mg, loratadine 10 mg, desloratadine 5 mg, levocetirizine 5 mg, fexofenadne 120 mg and 180 mg, or placebo respectively. The skin microcirculation reaction after 10 mg/ml histamine administration was estimated visually on the forearm (diameter of wheal and flare) and by Laser Doppler flowmetry before and after study drug or placebo administration prior and, 2, 4, 6, 8, 10, 12, 18, 24 h and one time daily every next 9 days.
There were significant differences of histamine-induced wheal, flare and skin blood flow inhibition vs baseline and placebo after drug administration. There were different dyr'mmics in suppression effect after histamine-induced skin reactivity in various drug groups. The overall inhibitory potency was statistically higher for cetirizine, levocetirizine and fexofenadine (even 95% ve basline) as compared to loratadine and desloratadine (even 65% vs basline). Different times of retreated inhibition effect after administered drugs were observed.
The study drugs shown significant different dynamics of skin reaction inhibition vs baseline and placebo. There were observed strongest effect after levocetirizine and cetirizine and next order after fexofenadine, desloratadine and loratadine.
本研究旨在比较健康人群单次服用各种第二代抗组胺药后对皮肤反应性的抑制效果。
42名健康受试者(年龄22±18岁)被随机分为七组,分别口服西替利嗪10毫克、氯雷他定10毫克、地氯雷他定5毫克、左西替利嗪5毫克、非索非那定120毫克和180毫克,或安慰剂。在给药前以及给药后2、4、6、8、10、12、18、24小时以及之后每9天每天一次,通过视觉评估前臂注射10毫克/毫升组胺后的皮肤微循环反应(风团和红晕直径),并使用激光多普勒血流仪进行测量。
给药后,与基线和安慰剂相比,组胺诱导的风团、红晕和皮肤血流抑制存在显著差异。不同药物组对组胺诱导的皮肤反应性的抑制作用动态不同。与氯雷他定和地氯雷他定相比(甚至分别为65% 与基线相比),西替利嗪、左西替利嗪和非索非那定的总体抑制效力在统计学上更高(甚至为95% 与基线相比)。观察到给药后不同时间的再抑制效果。
研究药物显示出与基线和安慰剂相比,皮肤反应抑制的显著不同动态。观察到左西替利嗪和西替利嗪的效果最强,其次是非索非那定、地氯雷他定和氯雷他定。