University Hospital, Department of Respiratory Diseases, Hôpital Arnaud de Villeneuve, Montpellier, France.
Curr Med Res Opin. 2012 Jan;28(1):131-9. doi: 10.1185/03007995.2011.648263. Epub 2011 Dec 22.
The ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines development group examined the properties of oral H(1)-antihistamines and made proposals about an 'optimal' drug. Several criteria should be met by oral H(1)-antihistamines in terms of their pharmacological, and clinical efficacy and safety profiles.
Bilastine, a new H(1)-antihistamine, has been approved in 28 European countries for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria in adults and children older than 12 years. To determine its potential place in therapy in the treatment of allergic rhinitis, this manuscript examines whether bilastine meets the criteria defined in the European Academy of Allergy and Clinical Immunology (EAACI)/ARIA proposals for oral H(1)-antihistamines.
The optimal properties of oral H(1)-antihistamines and current ARIA recommendations for their use in allergic rhinitis are presented, as well as relevant pharmacological and clinical data for bilastine obtained from the published literature that specifically address the defined criteria.
Bilastine is a potent inhibitor of the histamine H(1) receptor. Data from preclinical studies have confirmed its selectivity for the histamine H(1) receptor over other receptors, and demonstrated antihistaminic properties in vitro and in vivo. Bilastine does not interfere with the cytochrome P450 system and is devoid of cardiac side effects. Studies in healthy volunteers and patients have shown that bilastine does not affect driving ability, cardiac conduction or alertness. In large pivotal randomized, placebo-controlled trials (RCTs), bilastine had a favourable safety profile. Bilastine 20 mg once daily improved all nasal and ocular symptoms of allergic rhinitis with greater efficacy than placebo and comparable to that of cetirizine and desloratadine. Moreover, bilastine was shown to improve quality of life, an important outcome of RCTs in allergic diseases. There were no significant changes in laboratory tests, electrocardiograms or vital signs. A potential limitation of this assessment of bilastine is that it is a literature-based review and the findings are dependent upon the quality of the published evidence.
Bilastine meets current EAACI/ARIA criteria for medications used in the treatment of allergic rhinitis.
ARIA（过敏性鼻炎及其对哮喘的影响）指南制定小组研究了口服 H（1）抗组胺药的特性，并提出了关于“理想”药物的建议。口服 H（1）抗组胺药在药理学和临床疗效及安全性方面应符合若干标准。
比拉斯汀是一种新型 H（1）抗组胺药，已在 28 个欧洲国家获得批准，用于治疗成人和 12 岁以上儿童的变应性鼻结膜炎和荨麻疹。为了确定其在治疗变应性鼻炎方面的潜在地位，本文研究了比拉斯汀是否符合欧洲过敏与临床免疫学会（EAACI）/ARIA 关于口服 H（1）抗组胺药的建议中定义的标准。
本文介绍了口服 H（1）抗组胺药的理想特性和当前 ARIA 推荐的用途，以及从已发表文献中获得的比拉斯汀的相关药理学和临床数据，这些数据专门针对已定义的标准。
比拉斯汀是一种强效的组胺 H（1）受体抑制剂。临床前研究数据证实了其对组胺 H（1）受体的选择性，优于其他受体，并且在体外和体内均具有抗组胺特性。比拉斯汀不干扰细胞色素 P450 系统，无心脏副作用。在健康志愿者和患者中的研究表明，比拉斯汀不会影响驾驶能力、心脏传导或警觉性。在大型随机、安慰剂对照试验（RCT）中，比拉斯汀具有良好的安全性。比拉斯汀 20mg 每日 1 次治疗可改善过敏性鼻炎的所有鼻部和眼部症状，疗效优于安慰剂，与西替利嗪和地氯雷他定相当。此外，比拉斯汀还改善了生活质量，这是过敏性疾病 RCT 的一个重要结果。实验室检查、心电图或生命体征均无显著变化。对比拉斯汀的这种评估可能存在的局限性在于，这是一项基于文献的综述，研究结果取决于已发表证据的质量。
比拉斯汀符合当前 EAACI/ARIA 治疗过敏性鼻炎药物的标准。
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