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首页> 外文期刊>Clinical and experimental allergy : >Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: a randomized, double-blind, parallel-group study.
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Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: a randomized, double-blind, parallel-group study.

机译：相比于西替利嗪10 mg和安慰剂，比拉西汀20 mg对季节性变应性鼻炎的对症治疗的有效性和安全性：一项随机，双盲，平行分组研究。

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BACKGROUND: Bilastine is a new non-sedative H(1) receptor antagonist, indicated for the treatment of allergic rhinitis (AR) (seasonal and perennial). OBJECTIVE: To assess and compare the efficacy and safety of bilastine 20 mg vs. cetirizine 10 mg and placebo in relieving the symptoms of seasonal allergic rhinitis (SAR). METHODS: Overall, 683 SAR patients, aged 12-70 years, were randomized to a double-blind treatment with bilastine 20 mg, cetirizine 10 mg or placebo, once daily for 14 days, in 61 centres across Europe. Patients recorded reflective (over the past 12 h) and instantaneous nasal (obstruction, rhinorrhoea, itching and sneezing) and non-nasal (ocular tearing, redness and itching) symptom scores (NSS and NNSS, respectively) twice daily, according to a pre-determined severity scale to provide reflective and instantaneous total symptom scores (TSS). The primary efficacy measure was the area under curve (AUC) of reflective TSS over 14 days of treatment (TSS-AUC(0-14 days)). Secondary efficacy measures included mean change from baseline in TSS, NSS and NNSS; discomfort caused by AR; and investigator's clinical global impression of the treatment. Safety was assessed according to adverse events (AEs), laboratory tests and electrocardiograms. RESULTS: The mean TSS-AUC(0-14 days) (score x day) was reduced in bilastine- and cetirizine-treated groups to a similar and significantly greater extent, compared with placebo (76.5, 72.3 and 100.6, respectively; P<0.001). Similarly, bilastine and cetirizine were comparable and significantly superior to placebo for all secondary outcomes. While all treatments were well tolerated and the AE profiles of bilastine and placebo were similar, significantly fewer patients in the bilastine-treated group experienced somnolence (1.8%; P<0.001) and fatigue (0.4%; P=0.02) than patients in the cetirizine-treated group (7.5% and 4.8%, respectively). CONCLUSIONS: Bilastine 20 mg once daily was significantly superior to placebo and comparable to cetirizine 10 mg in relieving symptoms of SAR, although it demonstrated a significantly better AE profile than cetirizine.
机译：背景：Bilastine是一种新型的非镇静性H（1）受体拮抗剂，可用于治疗变应性鼻炎（AR）（季节性和多年生）。目的：评估和比较20 mg比拉汀，10 mg西替利嗪和安慰剂在缓解季节性变应性鼻炎（SAR）症状方面的疗效和安全性。方法：总共在欧洲61个中心将683名SAR患者（年龄在12-70岁之间）随机分为双盲治疗，每天一次，连续14天，每日一次，持续时间为14天，分别使用20 mg的比拉汀，10 mg的西替利嗪或安慰剂。根据一项预先检查，患者每天记录两次反射性（过去12小时内）和瞬时鼻（阻塞，鼻涕，瘙痒和打喷嚏）和非鼻（眼部撕裂，发红和瘙痒）症状评分（分别为NSS和NNSS）。确定的严重性量表，以提供反射性和瞬时总症状评分（TSS）。主要疗效指标是治疗14天（TSS-AUC（0-14天））中反射性TSS的曲线下面积（AUC）。次要疗效指标包括TSS，NSS和NNSS相对于基线的平均变化; AR引起的不适;以及研究者对该治疗的临床总体印象。根据不良事件（AE），实验室测试和心电图评估安全性。结果：与安慰剂组相比，比拉司汀和西替利嗪治疗组的平均TSS-AUC（0-14天）（评分x天）降低了相似的程度，并且显着更大（分别为76.5、72.3和100.6; P < 0.001）。同样，在所有次要结局中，比拉司汀和西替利嗪相当，并且显着优于安慰剂。尽管所有治疗的耐受性均良好，并且比拉司汀和安慰剂的AE曲线相似，但比拉司汀治疗组中出现嗜睡（1.8％; P <0.001）和疲劳（0.4％; P = 0.02）的患者明显少得多。西替利嗪治疗组（分别为7.5％和4.8％）。结论：每天一次的Bilastine 20 mg在缓解SAR症状方面显着优于安慰剂，与西替利嗪10 mg相当，尽管它表现出比西替利嗪更好的AE曲线。

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