Di Lorenzo G, Pacor M L, Pellitteri M E, Morici G, Di Gregoli A, Lo Bianco C, Ditta V, Martinelli N, Candore G, Mansueto P, Rini G B, Corrocher R, Caruso C
Dipartimento di Medicina Clinica e delle Patologie Emergenti, Università di Palermo, Italy.
Clin Exp Allergy. 2004 Feb;34(2):259-67. doi: 10.1111/j.1365-2222.2004.01877.x.
Corticosteroids are considered to be particularly effective in reducing nasal congestion and are therefore recommended as first-line treatment in allergic rhinitis patients with moderate to severe and/or persistent symptoms.
We compared the clinical efficacy of fluticasone propionate aqueous nasal spray (FPANS) 200 microg given once daily, administered in mono-therapy or combined therapy with a H1 receptor antagonist (cetirizine, CTZ) or with a leukotriene antagonist (montelukast, MSK), and the combined therapy of CTZ plus MSK in the treatment of patients affected by allergic rhinitis to Parietaria during natural pollen exposure. In addition, we examined the effect of the treatment on eosinophil counts and eosinophil cationic protein (ECP) in nasal lavage performed at beginning of season, during season and at the end of the season.
One hundred patients aged 12-50 years (mean+/-SD 31.8+/-9.6) with a history of moderate to severe Parietaria pollen-induced seasonal allergic rhinitis were selected. A randomized, double-blind, double dummy, placebo (PLA)-controlled, parallel-group study design was used. Patients were treated FPANS 200 microg once daily (n=20) or with FPANS 200 microg once daily, plus CTZ (10 mg) in the morning (n=20), or with FPANS 200 microg once daily, plus MSK (10 mg) in the evening (n=20) or with CTZ (10 mg) in the morning plus MSK in the evening (n=20) or matched PLA (n=20). Assessment of efficacy was based on scores of daily nasal symptoms and on eosinophil counts and ECP in nasal lavage.
All treatments showed significant differences (P<0.001) compared with PLA in terms of total symptom, rhinorrhea, sneezing and nasal itching scores. Concerning nasal congestion on waking and daily only the groups treated with FPANS in mono-therapy or in combined therapy showed significant differences compared with PLA. Comparing the group treated with FPANS alone and the groups treated with FPANS plus CTZ, we found significant differences for total symptom score (P=0.04) and for nasal itching (P=0.003). The comparison between FPANS plus CTZ and FPANS plus MSK showed significant difference for nasal itching (P=0.003). Finally, there were significant differences between the group treated with FPANS and the group treated with CTZ plus MSK for total symptom score (P=0.009), for nasal congestion on waking (P<0.001) and nasal congestion daily (P<0.001). Also the comparisons between the group treated with FPANS plus CTZ and the group treated with CTZ plus MSK demonstrated significant differences (P<0.001) for total symptom, for nasal congestion on waking and for nasal congestion on daily, for rhinorrhea (P=0.04) and for nasal itching (P=0.003) scores. Concerning the comparison between the group treated with FPANS plus MSK and the group treated with CTZ plus MSK we found significant differences for total symptom score (P=0.005), for nasal congestion on waking (P<0.001) and for nasal congestion on daily (P<0.001). No other differences were observed between the groups. Concerning blood eosinophil counts, significant differences were found between the treatments with FPANS in mono-therapy or in combined therapy with PLA group during and at the end of the season (P=0.0003 and P<0.0001, respectively). Concerning eosinophils and ECP in nasal lavage, all treatments showed significant differences (P<0.001) compared with PLA. Besides, there were significant differences (P<0.001) between the groups treated with FPANS alone or in combined therapy and the group treated with CTZ plus MSK.
The results of this comparative study demonstrate that FPANS is highly effective for treating patients affected by allergic rhinitis, with efficacy exceeding that of CTZ plus MSK in combined therapy. In addition, the regular combined therapy of FPANS plus CTZ or plus MSK would not seem to offer substantial advantage with respect to FPANS in mono-therapy in patients affected by seasonal allergic rhinitis.
皮质类固醇被认为在减轻鼻充血方面特别有效，因此被推荐作为中重度和/或持续性症状的变应性鼻炎患者的一线治疗药物。
我们比较了每日一次给予200μg丙酸氟替卡松水性鼻喷雾剂（FPANS）单药治疗，或与H1受体拮抗剂（西替利嗪，CTZ）或白三烯拮抗剂（孟鲁司特，MSK）联合治疗，以及CTZ加MSK联合治疗在自然花粉暴露期间治疗受墙草属花粉变应性鼻炎影响患者的临床疗效。此外，我们在季节开始时、季节期间和季节结束时进行的鼻腔灌洗中检查了治疗对嗜酸性粒细胞计数和嗜酸性粒细胞阳离子蛋白（ECP）的影响。
选择100例年龄在12 - 50岁（平均±标准差31.8±9.6）有中重度墙草属花粉诱导的季节性变应性鼻炎病史的患者。采用随机、双盲、双模拟、安慰剂（PLA）对照、平行组研究设计。患者接受每日一次200μg FPANS治疗（n = 20），或每日一次200μg FPANS加早晨服用CTZ（10mg）治疗（n = 20），或每日一次200μg FPANS加晚上服用MSK（10mg）治疗（n = 20），或早晨服用CTZ（10mg）加晚上服用MSK治疗（n = 20），或匹配的PLA治疗（n = 20）。疗效评估基于每日鼻症状评分以及鼻腔灌洗中的嗜酸性粒细胞计数和ECP。
与PLA相比，所有治疗在总症状、流涕、打喷嚏和鼻痒评分方面均显示出显著差异（P < 0.001）。关于晨起和每日的鼻充血，仅FPANS单药治疗或联合治疗组与PLA相比显示出显著差异。比较单独使用FPANS治疗组和使用FPANS加CTZ治疗组，我们发现总症状评分（P = 0.04）和鼻痒（P = 0.003）存在显著差异。FPANS加CTZ与FPANS加MSK之间的比较显示鼻痒存在显著差异（P = 0.003）。最后，FPANS治疗组与CTZ加MSK治疗组在总症状评分（P = 0.009）、晨起鼻充血（P < 0.001）和每日鼻充血（P < 0.001）方面存在显著差异。此外，FPANS加CTZ治疗组与CTZ加MSK治疗组在总症状、晨起鼻充血、每日鼻充血、流涕（P = 0.04）和鼻痒（P = 0.003）评分方面也显示出显著差异（P < 0.001）。关于FPANS加MSK治疗组与CTZ加MSK治疗组之间的比较，我们发现总症状评分（P = 0.005）、晨起鼻充血（P < 0.001）和每日鼻充血（P < 0.001）存在显著差异。各治疗组之间未观察到其他差异。关于血液嗜酸性粒细胞计数，在季节期间和季节结束时，FPANS单药治疗或与PLA联合治疗组之间存在显著差异（分别为P = 0.0003和P < 0.0001）。关于鼻腔灌洗中的嗜酸性粒细胞和ECP，与PLA相比，所有治疗均显示出显著差异（P < 0.001）。此外，单独使用FPANS或联合治疗组与CTZ加MSK治疗组之间存在显著差异（P < 0.001）。
这项比较研究的结果表明，FPANS对治疗受变应性鼻炎影响的患者非常有效，其疗效超过CTZ加MSK联合治疗。此外，对于季节性变应性鼻炎患者，FPANS加CTZ或加MSK的常规联合治疗相对于FPANS单药治疗似乎没有实质性优势。
