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丙酸氟替卡松与左卡巴斯汀治疗季节性变应性鼻炎的双盲、安慰剂对照比较。FLNCO2意大利研究组

A double-blind, placebo-controlled comparison of treatment with fluticasone propionate and levocabastine in patients with seasonal allergic rhinitis. FLNCO2 Italian Study Group.

作者信息

Ortolani C, Foresi A, Di Lorenzo G, Bagnato G, Bonifazi F, Crimi N, Emmi L, Prandini M, Senna G E, Tursi A, Mirone C, Leone C, Fina P, Testi R

机构信息

Divisione Bizzozzero di Medicina Interna, Ospedale Niguarda Milano, Italy.

出版信息

Allergy. 1999 Nov;54(11):1173-80. doi: 10.1034/j.1398-9995.1999.00200.x.

DOI:10.1034/j.1398-9995.1999.00200.x
PMID:10604553
Abstract

Fluticasone propionate aqueous nasal spray (FPANS) is a topically active glucocorticoid which has been successfully used for the treatment of seasonal allergic rhinitis (SAR). Topical levocabastine is a highly selective H1 antagonist which has been proposed as an alternative treatment of SAR. The purpose of this study was to compare the clinical efficacy of two topical nasal treatments, FPANS and levocabastine, in the treatment of SAR. Additionally, the effect of treatments on nasal inflammation was examined during natural pollen exposure. A group of 288 adolescent and adult patients with at least a 2-year history of SAR to seasonal pollens participated in a multicenter, doubleblind, double-dummy, and placebo-controlled study. Patients were treated with either FPANS 200 microg, once daily (n = 97), or topical levocabastine, 200 microg, given twice daily (n = 96), or matched placebo (n = 95) for a period of 6 weeks, starting from the expected beginning of the pollen season. Clinically relevant pollens included Parietaria, olive, and grass. Assessment of efficacy was based on scores of daily nasal symptoms and on nasal cytology of nasal lavage. Nasal lavage was performed immediately before, during, and at the end of treatment in 39 patients. FPANS significantly increased the percentage of symptom-free days for nasal obstruction on waking and during the day, rhinorrhea, sneezing, and itching. FPANS provided a better control for night and day nasal obstruction (P<0.02 and P<0.01) and rhinorrhea (P<0.01) than levocabas tine. In addition, fewer patients treated with FPANS used rescue medication (P<0.025). The percentage of eosinophils in nasal lavage was reduced only during treatment with FPANS. The results of this study indicate that FPANS 200 microg, once daily, provides a better clinical effect than levocabastine 200 microg, twice daily, in patients with SAR. Unlike levocabastine, FPANS significantly attenuates nasal eosinophilia during pollen exposure, a feature which may explain its therapeutic efficacy.

摘要

丙酸氟替卡松水性鼻喷雾剂(FPANS)是一种具有局部活性的糖皮质激素,已成功用于治疗季节性变应性鼻炎(SAR)。局部用左卡巴斯汀是一种高度选择性的H1拮抗剂,已被提议作为SAR的替代治疗方法。本研究的目的是比较两种局部鼻腔治疗方法,即FPANS和左卡巴斯汀,在治疗SAR中的临床疗效。此外,在自然花粉暴露期间检查了治疗对鼻炎症的影响。一组288名患有至少2年季节性花粉所致SAR病史的青少年和成年患者参与了一项多中心、双盲、双模拟和安慰剂对照研究。患者从花粉季节预期开始时起,接受以下治疗之一,为期6周:每日一次200微克的FPANS(n = 97),或每日两次200微克的局部用左卡巴斯汀(n = 96),或匹配的安慰剂(n = 95)。临床相关花粉包括墙草属、橄榄和草。疗效评估基于每日鼻症状评分和鼻灌洗的鼻细胞学检查。39名患者在治疗前、治疗期间和治疗结束时进行了鼻灌洗。FPANS显著增加了醒来时和白天鼻塞、流涕、打喷嚏和瘙痒的无症状天数百分比。与左卡巴斯汀相比,FPANS对夜间和白天鼻塞(P<0.02和P<0.01)和流涕(P<0.01)的控制更好。此外,接受FPANS治疗的患者使用急救药物的人数较少(P<0.025)。仅在使用FPANS治疗期间,鼻灌洗中嗜酸性粒细胞的百分比降低。本研究结果表明,对于SAR患者,每日一次200微克的FPANS比每日两次200微克的左卡巴斯汀具有更好的临床效果。与左卡巴斯汀不同,FPANS在花粉暴露期间显著减轻鼻嗜酸性粒细胞增多,这一特征可能解释了其治疗效果。

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