Day J H, Briscoe M P, Clark R H, Ellis A K, Gervais P
Division of Allergy and Immunology, Kingston General Hospital, Ontario, Canada.
Ann Allergy Asthma Immunol. 1997 Aug;79(2):163-72. doi: 10.1016/S1081-1206(10)63104-3.
Terfenadine, astemizole, cetirizine, and loratadine are compared in their abilities to produce relief of symptoms of allergic rhinitis.
The aim of this study was to compare the onset of action and efficacy of the study medications.
111 ragweed-sensitive subjects were primed with pollen in the Environmental Exposure Unit. Study entry required adequate symptoms over a 3 hour exposure to 5000 +/- 300 grains/m3 of ragweed pollen. On the test day, subjects were given a single dose of either terfenadine 60 mg (22), astemizole 10 mg (22), cetirizine 10 mg (23), loratadine 10 mg (22), or placebo (22) when sufficiently symptomatic after a 60-minute exposure. Allergen levels were maintained and symptoms recorded every 30 minutes.
Proportions of subjects with clinically important relief were cetirizine, 69.6%; terfenadine, 54.5%; loratadine, 50.0%; astemizole, 40.9%; and placebo, 31.8% but differences weren't significant between treatment groups (P = .119). Survival curves for times to onset of clinically important relief for the four treatment groups were not different (P = .119). Subjects realizing definitive relief were cetirizine, 65.2%; terfenadine, 45.5%; loratadine, 31.8%; placebo, 27.3%; and astemizole, 22.7% (P = .023). Survival analysis of onset time for definitive relief found significant differences (P = .010). The ranking was cetirizine --> terfenadine --> loratadine --> astemizole (quickest to slowest). Global evaluation based on subject willingness to take the medication again yielded percentages: cetirizine, 82.6%; terfenadine, 66.7%; astemizole, 63.6%; loratadine, 40.9%; and placebo, 36.4% (P = .036).
Cetirizine and terfenadine continuously ranked higher in terms of onset of action and efficacy, while loratadine and astemizole ranked lower. Significance was detected in definitive relief and relative efficacy.
比较特非那定、阿司咪唑、西替利嗪和氯雷他定缓解过敏性鼻炎症状的能力。
本研究旨在比较受试药物的起效时间和疗效。
111名对豚草敏感的受试者在环境暴露单元中接触花粉致敏。研究入选要求在暴露于5000±300粒/立方米豚草花粉3小时期间出现足够的症状。在测试日，当受试者在60分钟暴露后出现足够症状时，给予单剂量的特非那定60毫克（22例）、阿司咪唑10毫克（22例）、西替利嗪10毫克（23例）、氯雷他定10毫克（22例）或安慰剂（22例）。维持过敏原水平并每30分钟记录一次症状。
临床症状得到显著缓解的受试者比例为：西替利嗪69.6%；特非那定54.5%；氯雷他定50.0%；阿司咪唑40.9%；安慰剂31.8%，但各治疗组之间差异无统计学意义（P = 0.119）。四个治疗组达到临床显著缓解的起效时间的生存曲线无差异（P = 0.119）。实现完全缓解的受试者比例为：西替利嗪65.2%；特非那定45.5%；氯雷他定31.8%；安慰剂27.3%；阿司咪唑22.7%（P = 0.023）。对完全缓解的起效时间进行生存分析发现有显著差异（P = 0.010）。排序为西替利嗪>特非那定>氯雷他定>阿司咪唑（从最快到最慢）。基于受试者再次愿意服用该药物的总体评估得出的百分比为：西替利嗪82.6%；特非那定66.7%；阿司咪唑63.6%；氯雷他定40.9%；安慰剂36.4%（P = 0.036）。
在起效时间和疗效方面，西替利嗪和特非那定的排名持续较高，而氯雷他定和阿司咪唑的排名较低。在完全缓解和相对疗效方面检测到显著差异。
