Bousquet J, Chanal I, Murrieta M, Stalla-Bourdillon A
Hôpital Arnaud de Villeneuve, Montpellier, France.
Allergy. 1996 Apr;51(4):251-6. doi: 10.1111/j.1398-9995.1996.tb04601.x.
Mizolastine is a new, nonsedating antihistamine providing satisfactory symptom relief in allergic rhinitis and urticaria. The purpose of this study was to use the wheal and flare skin reactions model to assess the maintenance of the pharmacodynamic effect of mizolastine, administered for 2 months. This double-blind, parallel-group study involved 60 atopic patients randomly allocated, after a 1-week placebo run-in, to once-daily 10 mg mizolastine (n = 29) or placebo (n = 31) groups. Treatment continued for 8 weeks. Prick tests were performed in duplicate with histamine chlorhydrate (10 mg/ml), codeine phosphate (9%), and five increasing concentrations (1-500 reactivity index/ml) of standardized allergen extracts (grass pollen or mites) at days 0, 7, 28, 42, and 56. After 7 days of treatment, inhibition of histamine-induced wheal was -76% and +20%, respectively, with mizolastine and placebo (P = 0.0001), in comparison with baseline; inhibition of flare was -86% and +5%, respectively, with mizolastine and placebo (P = 0.0001). Suppression was maintained to a similar extent throughout the study. Results were consistent between histamine-, codeine-, and allergen-induced tests. Safety was satisfactory in both groups. The study confirms mizolastine as a potent antihistamine which does not induce subsensitivity when taken for 8 weeks, and which can be safely recommended in allergic conditions.
咪唑斯汀是一种新型非镇静性抗组胺药，可有效缓解过敏性鼻炎和荨麻疹的症状。本研究旨在通过风团和潮红皮肤反应模型，评估连续服用2个月的咪唑斯汀的药效维持情况。这项双盲、平行组研究纳入了60名特应性患者，在经过1周的安慰剂导入期后，将他们随机分为两组，分别每日服用10 mg咪唑斯汀（n = 29）或安慰剂（n = 31），治疗持续8周。在第0、7、28、42和56天，使用磷酸组胺（10 mg/ml）、磷酸可待因（9%）以及五种浓度递增（1 - 500反应指数/ml）的标准化变应原提取物（草花粉或螨虫）进行重复点刺试验。治疗7天后，与基线相比，咪唑斯汀和安慰剂对组胺诱导的风团抑制率分别为 -76% 和 +20%（P = 0.0001）；对潮红的抑制率分别为 -86% 和 +5%（P = 0.0001）。在整个研究过程中，抑制作用维持在相似水平。组胺、可待因和变应原诱导试验的结果一致。两组的安全性均良好。该研究证实，咪唑斯汀是一种强效抗组胺药，连续服用8周不会引起敏感性下降，可安全用于治疗过敏性疾病。
