Randomized double-blind study of prophylactic treatment with an antihistamine for seasonal allergic rhinitis
Randomized double-blind study of prophylactic treatment with an antihistamine for seasonal allergic rhinitis
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抗组胺药预防性治疗季节性过敏性鼻炎的随机双盲研究
DOI：
10.1159/000350926
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发表时间：
2013
期刊：
影响因子：
--
通讯作者：
Hanazawa T
中科院分区：
文献类型：
--
作者：
Yonekura S;Okamoto Y;Yamamoto H;Sakurai T;Iinuma T;Sakurai D;Hanazawa T
背景在花粉传播开始前进行预防性治疗对预防症状加重的有效性尚不清楚。本研究的目的是探讨预防性治疗的有效性与抗组胺药季节性变应性鼻炎（SAR）使用环境挑战chamber（ECC）.MethodsThe研究是在一个随机双盲的方式与3-way交叉设计。受试者是50名患有由日本雪松花粉引起的SAR的患者，他们被随机分配接受盐酸左西替利嗪5 mg（Xyzal®）或安慰剂治疗，如下：给予安慰剂8天（治疗A），在安慰剂7天后第8天单次给予左西替利嗪（治疗B）或给予左西替利嗪8天（治疗C）。基于ECC中第9天的雪松花粉暴露3小时（第8天暴露1小时后），评价每个治疗组的疗效。主要终点是第9天12小时的鼻部症状总评分。其他鼻和眼部症状的次要endpoints.ResultsThe评价进行了45例。与治疗A相比，治疗B在第9天的总鼻部症状评分显著较低。治疗C并没有表现出上级疗效与治疗B。ConclusionsOur结果表明，早期干预与左西替利嗪症状发作后不久，可以有效地减轻这些症状的预防性治疗花粉传播前。这些结果从患者方便和降低医疗成本的角度来看是重要的。
BackgroundThe efficacy of prophylactic treatment before the start of pollen dispersal for prevention of aggravation of symptoms is unclear. The aim of the present study was to examine the efficacy of prophylactic treatment with an antihistamine for seasonal allergic rhinitis (SAR) using an environmental challenge chamber (ECC).MethodsThe study was performed in a randomized double-blind manner with a 3-way crossover design. The subjects were 50 patients with SAR caused by Japanese cedar pollen who were randomized for treatment with levocetirizine hydrochloride 5 mg (Xyzal®) or placebo as follows: administration of placebo for 8 days (treatment A), single administration of levocetirizine on day 8 after placebo for 7 days (treatment B) or administration of levocetirizine for 8 days (treatment C). Efficacy in each treatment arm was evaluated based on cedar pollen exposure for 3 h on day 9 in an ECC, following 1-hour exposure on day 8. The primary endpoint was the total nasal symptom score for 12 h on day 9. Other nasal and ocular symptoms were secondary endpoints.ResultsThe evaluation was performed in 45 subjects. The total nasal symptom score on day 9 was significantly lower with treatment B compared with treatment A. Treatment C did not show superior efficacy compared with treatment B.ConclusionsOur results suggest that early intervention with levocetirizine soon after onset of symptoms may attenuate these symptoms as effectively as prophylactic treatment before pollen dispersal. These results are important from the perspective of patient convenience and reduction of medical costs.