bilastine减轻慢性自发性荨麻疹患者瘙痒的安全性和临床疗效

A. Bogomolov
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引用次数: 0

摘要

目的:评价bilastine缓解慢性自发性荨麻疹患者瘙痒的疗效和安全性。材料和方法。这项前瞻性随机研究纳入了50例年龄在18 - 59岁的慢性自发性荨麻疹和瘙痒的成年患者,在过去3天内,瘙痒的视觉模拟量表评估强度超过4分,在过去一周的慢性荨麻疹强度评估中,荨麻疹活动评分7 (UAS7)超过16分。患者口服bilastine,剂量为20mg,每天1次,持续8周。在前两周内对治疗没有反应的患者随后接受bilastine,剂量为每天40mg(两片20mg片),直到研究结束(持续6周)。结果和讨论。患者平均年龄为39.61岁,标准差为12.33岁。在初始治疗阳性的患者中,8周内瘙痒强度评分水平显著下降至0.46 (95% CI: 0.14-0.78)分(p < 0.05)。双剂量bilastine组瘙痒强度也有所降低,治疗第8周瘙痒强度平均为0.48 (95% CI: 0.26 ~ 0.70)点(p < 0.05)。该研究报告了10例(23.8%)患者在bilastine治疗期间发生的14例不良事件(AE)。所有病例均为轻度,最常见的是头痛,共有12例(85.7%)。研究期间未报告中度或重度不良事件。结论:8周的bilastine治疗在根据UAS7降低荨麻疹活动指数和在没有中度和重度ae的情况下降低瘙痒强度方面已被证明具有临床疗效。在加倍bilastine剂量后对开始治疗无反应的患者也根据UAS7显着降低了荨麻疹活动指数并降低了瘙痒强度。同时,增加药物剂量并没有导致不良反应发生频率的增加。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety and clinical efficacy of bilastine in reduction of pruritus in patients with chronic spontaneous urticaria
Objective — to evaluate the efficacy/safety of bilastine in relieving pruritus in patients with chronic spontaneous urticaria. Materials and methods. This prospective randomized study included 50 adult patients aged 18 to 59 years with chronic spontaneous urticaria and pruritus with an intensity of more than 4 points by the visual analog scale of pruritus assessment in the last 3 days and more than 16 points by the Urticaria activity score 7 (UAS7) which assessed chronic urticaria intensity for the last week.Patients received bilastine orally at a dose of 20 mg once a day for 8 weeks. Patients who did not respond to therapy within the first 2 weeks subsequently received bilastine at a dose of 40 mg per day (two 20 mg tablets) till the end of the study (for 6 weeks). Results and discussion. The mean age of patients was 39.61 years with standard deviation (SD) of 12.33 years. In the group of patients who responded positively to the initial therapy, within 8 weeks, the pruritus intensity scoring level decreased significantly to 0.46 (95 % CI: 0.14—0.78) points (p < 0.05). The patients who received a double dose of bilastine also revealed a decrease in the intensity of pruritus and on average on the 8th week of treatment had 0.48 (95 % CI: 0.26—0.70) points (p < 0.05).The study reported 14 adverse events (AE) that occurred during bilastine treatment in 10 (23.8 %) patients. All of them were classified as mild and the most common was headache, registered in 12 (85.7 %) cases. No moderate or severe AEs were reported during the study. Conclusions. 8 week treatment with bilastine has demonstrated proven clinical efficacy both in reducing the urticaria activity index according to UAS7 and in reducing the intensity of pruritus in the absence of moderate and severe AEs. Patients who did not respond to starting therapy after doubling the bilastine dose also significantly decreased the urticaria activity index according to UAS7 and reduced the intensity of pruritus. At the same time, increasing the dose of the drug did not lead to an increase in the frequency of AEs.
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