Negrini A C, Troise C, Voltolini S, Horak F, Bachert C, Janssens M
Service of Allergy, San Martino Hospital, Genova, Italy.
Clin Exp Allergy. 1995 Jan;25(1):60-5. doi: 10.1111/j.1365-2222.1995.tb01003.x.
This international, multicentre, randomized, double-blind, double-dummy, parallel-group trial was undertaken to compare the efficacy and tolerability of once-daily astemizole-D (10 mg astemizole plus 240 mg pseudoephedrine) with beclomethasone nasal spray (0.05 mg/ml) two puffs/nostril administered twice daily in a total of 204 patients with seasonal allergic rhinitis. Treatment duration was 4 weeks. Although investigator assessments of symptom severity were generally comparable in the two treatment groups throughout the trial, statistically significant differences in favour of astemizole-D for sneezing and ocular symptoms were apparent at the end of the 4-week treatment period (P < 0.05). Patient diary data support these findings, with significant differences in favour of the antihistamine/decongestant combination reported for ocular symptoms after 2 weeks of treatment (P < 0.05) and non-significant trends for sneezing after 2 weeks and ocular symptoms over the entire treatment period (P = 0.07). Use of rescue medication for ocular symptoms was also significantly lower in the astemizole-D treatment group (P < 0.05). A wide range of adverse experiences were reported, however, there were no statistically significant differences in the type or incidence of those between the two treatment groups. In conclusion, astemizole-D appears to be at least as effective and well tolerated as intranasal beclomethasone in the treatment of seasonal allergic rhinitis, providing at least comparable relief from all nasal symptoms including congestion and significantly greater relief from ocular symptoms than the topical steroid.
这项国际多中心随机双盲双模拟平行组试验旨在比较204例季节性变应性鼻炎患者中，每日一次的阿司咪唑-D（10毫克阿司咪唑加240毫克伪麻黄碱）与倍氯米松鼻喷雾剂（0.05毫克/毫升，每侧鼻孔喷两下，每日两次）的疗效和耐受性。治疗持续时间为4周。尽管在整个试验中，两个治疗组的研究者对症状严重程度的评估总体相当，但在4周治疗期结束时，阿司咪唑-D在打喷嚏和眼部症状方面有统计学显著差异（P<0.05）。患者日记数据支持这些发现，治疗2周后，眼部症状方面抗组胺药/减充血剂组合有显著差异（P<0.05），治疗2周时打喷嚏以及整个治疗期眼部症状有非显著趋势（P = 0.07）。阿司咪唑-D治疗组眼部症状使用急救药物的情况也显著更低（P<0.05）。报告了广泛的不良事件，然而，两个治疗组之间不良事件的类型或发生率没有统计学显著差异。总之，在治疗季节性变应性鼻炎方面，阿司咪唑-D似乎至少与鼻内倍氯米松一样有效且耐受性良好，在缓解包括鼻塞在内的所有鼻部症状方面至少相当，且在缓解眼部症状方面比局部用类固醇显著更有效。
