Sabbah A, Marzetto M
CHU d'Angers, France.
Curr Med Res Opin. 1998;14(3):161-70. doi: 10.1185/03007999809113356.
In a randomised, multicentre study, the effect of azelastine eye drops (n = 51 patients) was compared in a double-blind manner with placebo eye drops (n = 30 patients) and in an open manner with levocabastine eye drops (n = 32 patients) during a 14-day treatment period involving 113 children (aged 4 to 12 years) suffering from seasonal allergic conjunctivitis/rhinoconjunctivitis. The primary variable was the response rate defined as the number of patients showing an improvement after three days of treatment of at least three score points, from a minimum baseline score of six, in the main ocular symptoms of itching, conjunctival redness and lacrimation (each assessed on a four-point scale). Patients discontinuing due to inefficacy were regarded as non-responders. The mean response rate in the azelastine eye drops group (74%) was significantly higher (p < 0.01) than that in the placebo group (39%) and comparable with that in the levocabastine group. The response rates assessed by the patients in their diaries were very similar. Significant differences (p < 0.01) for azelastine compared with placebo were observed on days 3 and 14 in the mean sum scores for the three main symptoms and for a total of eight eye symptoms. The overall assessment of efficacy confirmed the superiority of both active treatments compared with placebo. Adverse drug reactions were reported in 23% of placebo-, 35% of azelastine- and 38% of levocabastine-treated patients. These were mainly local irritant effects. Overall tolerability was assessed as very good or good in 80%, 84% and 91% of placebo-, azelastine- and levocabastine-treated patients, respectively. Azelastine eye drops are effective and well-tolerated in children with seasonal allergic conjunctivitis.
在一项随机、多中心研究中，在为期14天的治疗期内，对113名患有季节性过敏性结膜炎/鼻结膜炎的儿童（4至12岁），以双盲方式比较了氮卓斯汀滴眼液（51例患者）与安慰剂滴眼液（30例患者）的效果，并以开放方式比较了其与左卡巴斯汀滴眼液（32例患者）的效果。主要变量是缓解率，定义为在治疗三天后，主要眼部症状瘙痒、结膜充血和流泪（每项按四分制评估），从最低基线分数6分至少改善三分的患者数量。因无效而停药的患者被视为无反应者。氮卓斯汀滴眼液组的平均缓解率（74%）显著高于安慰剂组（39%）（p<0.01），且与左卡巴斯汀组相当。患者在日记中评估的缓解率非常相似。与安慰剂相比，氮卓斯汀在第3天和第14天，在三种主要症状的平均总分以及总共八种眼部症状方面，观察到显著差异（p<0.01）。疗效的总体评估证实，两种活性治疗均优于安慰剂。安慰剂治疗患者中有23%、氮卓斯汀治疗患者中有35%、左卡巴斯汀治疗患者中有38%报告了药物不良反应。这些主要是局部刺激作用。安慰剂、氮卓斯汀和左卡巴斯汀治疗的患者中，总体耐受性被评估为非常好或良好的分别为80%、84%和91%。氮卓斯汀滴眼液对患有季节性过敏性结膜炎的儿童有效且耐受性良好。
