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依巴斯汀、特非那定与安慰剂治疗成人慢性特发性荨麻疹的双盲多中心对照研究

Double-blind multicentre comparative study of ebastine, terfenadine and placebo in the treatment of chronic idiopathic urticaria in adults.

作者信息

Kalis B

机构信息

Service de Dermatologie, Hôpital Robert Debré, Reims, France.

出版信息

Drugs. 1996;52 Suppl 1:30-4. doi: 10.2165/00003495-199600521-00008.

Abstract

Ebastine is a new second generation histamine H1 receptor antagonist that has shown clinical efficacy in the treatment of seasonal and perennial allergic rhinitis and chronic urticaria after once-daily administration. This double-blind multicentre randomised placebo-controlled study has investigated the long term efficacy of ebastine 10mg once daily in the treatment of chronic urticaria compared with that of terfenadine 60mg twice daily. At the end of a 3-month treatment period, ebastine was significantly superior to placebo in improving symptoms of chronic urticaria (including severity of itching, number of wheals per day), and its efficacy was similar to that of terfenadine. In a global assessment of efficacy, investigators considered chronic urticaria to have improved in 73% of ebastine recipients compared with 68% and 52% of patients treated with terfenadine or placebo, respectively. The patients' assessments of efficacy were similar to those of the investigators. Ebastine was well tolerated, the incidence and nature of adverse events with this agent being similar to those reported in patients treated with terfenadine or placebo. The most common adverse events were headache and dry mouth. Thus, these results, which show ebastine to be an effective and well tolerated agent, indicated that the drug should be considered for the first-line therapy of chronic urticaria.

摘要

依巴斯汀是一种新型第二代组胺H1受体拮抗剂,每日一次给药后已显示出对季节性和常年性变应性鼻炎及慢性荨麻疹的临床疗效。这项双盲多中心随机安慰剂对照研究,调查了每日一次服用10mg依巴斯汀与每日两次服用60mg特非那定相比,在治疗慢性荨麻疹方面的长期疗效。在3个月治疗期结束时,依巴斯汀在改善慢性荨麻疹症状(包括瘙痒严重程度、每日风团数量)方面显著优于安慰剂,其疗效与特非那定相似。在疗效的整体评估中,研究者认为73%服用依巴斯汀的患者慢性荨麻疹有所改善,相比之下,服用特非那定或安慰剂的患者分别为68%和52%。患者对疗效的评估与研究者相似。依巴斯汀耐受性良好,该药物不良事件的发生率和性质与服用特非那定或安慰剂患者报告的相似。最常见的不良事件是头痛和口干。因此,这些显示依巴斯汀是一种有效且耐受性良好药物的结果表明,该药物应被考虑用于慢性荨麻疹的一线治疗。

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