Ciprandi G, Ricca V, Passalacqua G, Truffelli T, Bertolini C, Fiorino N, Riccio A M, Bagnasco M, Canonica G W
Department of Internal Medicine, Genoa University, Italy.
J Allergy Clin Immunol. 1997 Mar;99(3):301-7. doi: 10.1016/s0091-6749(97)70046-0.
Azelastine is a topical antihistamine, clinically demonstrated to be effective in allergic rhinitis.
We evaluated the clinical efficacy and the antiallergic activity of azelastine nasal spray, administered 0.56 mg per day, 0.28 mg per day, or on demand over a 3-month period during natural allergen exposure, in a double-blind, placebo-controlled fashion.
Thirty patients, sensitized to grass or Parietaria pollen, were allocated to three treatment groups: those receiving the standard dosage (0.14 mg/nostril two times a day), half the dosage (0.07 mg/nostril two times a day), or placebo daily for 3 months. All patients were allowed to take additional doses of azelastine when needed. Evaluation parameters were as follows: clinical symptoms recorded on a diary card, number of additional, on-demand azelastine puffs, nasal inflammatory cell count, intercellular adhesion molecule-1 expression on nasal epithelial cells, and pollen count.
This study showed the following: (1) the half dose (0.28 mg/day) and the standard dose (0.56 mg/day) were equally effective in reducing clinical symptoms (p = NS), although the standard dosage required fewer additional puffs during times of peak pollen counts (p < 0.05); (2) both dosages were able to reduce the allergic inflammation (p < 0.05 vs placebo); and (3) on-demand use achieved acceptable clinical control but did not significantly reduce allergic inflammation.
Continuous treatment was more effective than on-demand use as assessed by both clinical evaluation and antiinflammatory action.
氮卓斯汀是一种局部用抗组胺药，临床证明对过敏性鼻炎有效。
我们以双盲、安慰剂对照的方式，评估了在自然过敏原暴露期间，每天给药0.56毫克、每天给药0.28毫克或按需给药的氮卓斯汀鼻喷雾剂在3个月内的临床疗效和抗过敏活性。
30名对草或墙草花粉过敏的患者被分配到三个治疗组：分别接受标准剂量（0.14毫克/每侧鼻孔，每日两次）、半剂量（0.07毫克/每侧鼻孔，每日两次）或安慰剂，为期3个月。所有患者在需要时可额外使用氮卓斯汀。评估参数如下：日记卡上记录的临床症状、额外按需使用的氮卓斯汀喷雾次数、鼻炎性细胞计数、鼻上皮细胞上细胞间黏附分子-1的表达以及花粉计数。
本研究显示如下结果：（1）半剂量（0.28毫克/天）和标准剂量（0.56毫克/天）在减轻临床症状方面同样有效（p = 无显著性差异），尽管在花粉计数高峰期，标准剂量所需的额外喷雾次数较少（p < 0.05）；（2）两种剂量均能减轻过敏性炎症（与安慰剂相比，p < 0.05）；（3）按需使用可实现可接受的临床控制，但并未显著减轻过敏性炎症。
通过临床评估和抗炎作用评估，持续治疗比按需使用更有效。
