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糠酸莫米松(内舒拿)每日一次与丙酸氟替卡松水性鼻喷雾剂治疗常年性鼻炎的比较。194 - 079研究组。

Comparison of once daily mometasone furoate (Nasonex) and fluticasone propionate aqueous nasal sprays for the treatment of perennial rhinitis. 194-079 Study Group.

作者信息

Mandl M, Nolop K, Lutsky B N

机构信息

Department of Medicine, St. Paul's Hospital, University of British Colombia, Vancouver, Canada.

出版信息

Ann Allergy Asthma Immunol. 1997 Oct;79(4):370-8. doi: 10.1016/s1081-1206(10)63030-x.

DOI:10.1016/s1081-1206(10)63030-x
PMID:9357385
Abstract

BACKGROUND

Mometasone furoate (Nasonex), in a new once-daily aqueous nasal spray formulation, has been shown to be as effective and well-tolerated as twice-daily beclomethasone dipropionate aqueous nasal spray in treating symptoms of seasonal allergic rhinitis and perennial rhinitis.

OBJECTIVE

To compare the effectiveness and tolerability of mometasone furoate to placebo and of fluticasone propionate aqueous nasal spray, all treatments administered once-daily, in patients with perennial rhinitis.

METHODS

This was a 3-month, randomized, double-blind, double dummy, parallel group study in 550 patients, aged 12 to 77 years, at 25 centers in Canada, Latin America, and Europe. Patients allergic to at least one perennial allergen, with confirmed allergy history, skin test positivity, and moderate to severe symptomatology, were eligible to receive one of the following treatments, once daily in the morning: mometasone furoate 200 micrograms, fluticasone propionate 200 micrograms, or placebo. The primary efficacy variable was the change from baseline in total AM plus PM diary nasal symptom score over the first 15 days of treatment.

RESULTS

Four hundred fifty-nine patients were valid for efficacy. For the primary efficacy variable, mometasone furoate was significantly (P < .01) more effective than placebo and was not statistically different from fluticasone propionate (percent reductions from baseline were 37, 39, and 22 for mometasone furoate, fluticasone propionate, and placebo, respectively). Generally, similar trends were seen for physician-evaluated total nasal symptoms, and patient-rated and physician-rated overall condition and response to therapy. Overall, mometasone furoate was at least as effective as fluticasone propionate at equivalent doses. There was no evidence of tachyphylaxis. All treatments were well tolerated.

CONCLUSION

Mometasone furoate and fluticasone propionate adequately controlled symptoms of perennial rhinitis and were well tolerated.

摘要

背景

糠酸莫米松(内舒拿)采用一种新的每日一次水性鼻喷雾剂剂型,在治疗季节性变应性鼻炎和常年性鼻炎症状方面,已显示出与每日两次的二丙酸倍氯米松水性鼻喷雾剂具有同样的疗效和耐受性。

目的

比较糠酸莫米松与安慰剂以及丙酸氟替卡松水性鼻喷雾剂(均为每日一次给药)对常年性鼻炎患者的疗效和耐受性。

方法

这是一项为期3个月的随机、双盲、双模拟、平行组研究,涉及加拿大、拉丁美洲和欧洲25个中心的550例年龄在12至77岁的患者。对至少一种常年性变应原过敏、有确诊过敏史、皮肤试验阳性且有中度至重度症状的患者,有资格接受以下治疗之一,于每天早晨给药一次:200微克糠酸莫米松、200微克丙酸氟替卡松或安慰剂。主要疗效变量是治疗前15天上午加下午日记鼻症状总分相对于基线的变化。

结果

459例患者疗效评估有效。对于主要疗效变量,糠酸莫米松比安慰剂显著更有效(P < 0.01),与丙酸氟替卡松无统计学差异(糠酸莫米松、丙酸氟替卡松和安慰剂相对于基线的降低百分比分别为37%、39%和22%)。一般而言,在医生评估的总鼻症状、患者评分和医生评分的总体状况及对治疗的反应方面观察到类似趋势。总体而言,糠酸莫米松在等效剂量下至少与丙酸氟替卡松一样有效。没有快速耐受的证据。所有治疗耐受性良好。

结论

糠酸莫米松和丙酸氟替卡松能充分控制常年性鼻炎症状,且耐受性良好。

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