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氮卓斯汀鼻喷雾剂治疗季节性变应性鼻炎的临床评估

[Clinical assessment of azelastine nasal spray in seasonal allergic rhinitis].

作者信息

Arcimowicz M, Samoliński B, Zawisza E

机构信息

Katedry i Kliniki Otolaryngologii Akademii Medycznej w Warszawie.

出版信息

Pol Merkur Lekarski. 1998 Dec;5(30):363-7.

Abstract

The authors have studied the effect of azelastine nasal spray in the treatment of seasonal allergic rhinitis. The trial was a double-blind, placebo controlled study, with 33 allergic subjects (17 female, 16 male), 15-40 years old. The patients were randomized into two parallel groups, to receive daily 0.56 mg of azelastine intranasally or placebo during two weeks. Before and after treatment severity of nasal symptoms such as: sneezing, itching, nasal blockage, nasal discharge and general feeling were evaluated by patients according to VAS (visual analogue scale). At the same time the physician's evaluation of nasal oedema, nasal discharge and general patient's condition were performed (VAS). Additionally during the treatment patients noted possible adverse events. Patient's and physician's evaluations showed clinical efficacy in the azelastine group and no evident efficacy in the placebo group--between those two groups statistical significances were noted for all evaluated parameters (p < 0.001). The bitter taste in the mouth was the only serious side effect in some patients in azelastine group, although this was quite well accepted. Generally the treatment was well-tolerated. Azelastine nasal spray is an effective and well-tolerated drug in the treatment of seasonal allergic rhinitis.

摘要

作者研究了氮卓斯汀鼻喷雾剂治疗季节性变应性鼻炎的效果。该试验为双盲、安慰剂对照研究,有33名变应性受试者(17名女性,16名男性),年龄在15至40岁之间。患者被随机分为两个平行组,在两周内每天鼻内给予0.56毫克氮卓斯汀或安慰剂。治疗前后,患者根据视觉模拟量表(VAS)对打喷嚏、瘙痒、鼻塞、流涕和总体感觉等鼻部症状的严重程度进行评估。同时,医生对鼻水肿、流涕和患者总体状况进行评估(VAS)。此外,在治疗期间,患者记录可能的不良事件。患者和医生的评估显示,氮卓斯汀组有临床疗效,而安慰剂组无明显疗效——两组之间在所有评估参数上均有统计学意义(p<0.001)。口中苦味是氮卓斯汀组部分患者唯一的严重副作用,不过这种副作用相当容易接受。总体而言,该治疗耐受性良好。氮卓斯汀鼻喷雾剂是治疗季节性变应性鼻炎的一种有效且耐受性良好的药物。

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