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糠酸莫米松鼻喷雾剂(内舒拿)治疗季节性变应性鼻炎的起效时间。

Onset of action of mometasone furoate nasal spray (NASONEX) in seasonal allergic rhinitis.

作者信息

Berkowitz R B, Bernstein D I, LaForce C, Pedinoff A J, Rooklin A R, Damaraju C R, Mesarina-Wicki B, Nolop K B

机构信息

Atlanta Allergy and Immunology Research Foundation, GA, USA.

出版信息

Allergy. 1999 Jan;54(1):64-9. doi: 10.1034/j.1398-9995.1999.00713.x.

DOI:10.1034/j.1398-9995.1999.00713.x
PMID:10195359
Abstract

BACKGROUND

Mometasone furoate nasal spray (MFNS, NASONEX ), is a new synthetic corticosteroid with considerable efficacy in the treatment of seasonal and perennial rhinitis and less than 0.1% systemic absorption. This study was designed to evaluate the time of onset of action of MFNS. The subjects were evaluated over the course of 2 weeks during the spring allergy season.

METHODS

The effects of MFNS 200 microg given once daily for 2 weeks were evaluated in a randomized, multicenter, double-blind, placebo-controlled study in 201 patients with seasonal allergic rhinitis. Clinically significant onset of action was assessed prospectively by special patient diary cards kept during the first 3 days of treatment.

RESULTS

By 12 h after initial dosage (the earliest evaluation), 28% of patients in the MFNS group experienced clinically significant relief, compared with 13% of those given placebo (P = 0.01). Median time to at least moderate symptom relief in patients who received MFNS was 35.9 h, compared with more than 72 h in patients given placebo (P<0.01). By 72 h, 64% of the patients receiving MFNS experienced at least moderate relief, compared with 40% of those treated with placebo (P<0.01). Both patient and physician ratings of symptom severity, response to treatment, and overall condition of rhinitis indicated significant (P<0.01) superiority of MFNS over placebo. MFNS was well tolerated, with adverse events comparable to placebo.

CONCLUSIONS

MFNS provided rapid onset of clinically significant symptom relief in patients with seasonal allergic rhinitis.

摘要

背景

糠酸莫米松鼻喷雾剂(MFNS,内舒拿)是一种新型合成皮质类固醇,在治疗季节性和常年性鼻炎方面疗效显著,全身吸收率低于0.1%。本研究旨在评估MFNS的起效时间。在春季过敏季节对受试者进行了为期2周的评估。

方法

在一项随机、多中心、双盲、安慰剂对照研究中,对201例季节性过敏性鼻炎患者给予每日一次200微克的MFNS,持续2周,评估其效果。在治疗的前3天,通过特殊的患者日记卡对具有临床意义的起效情况进行前瞻性评估。

结果

初始给药后12小时(最早评估时间),MFNS组28%的患者出现了具有临床意义的症状缓解,而给予安慰剂的患者中这一比例为13%(P = 0.01)。接受MFNS治疗的患者至少获得中度症状缓解的中位时间为35.9小时,而给予安慰剂的患者这一数值超过72小时(P<0.01)。到72小时时,接受MFNS治疗的患者中有64%至少获得中度缓解,而接受安慰剂治疗的患者中这一比例为40%(P<0.01)。患者和医生对症状严重程度、治疗反应以及鼻炎总体状况的评分均表明,MFNS显著优于安慰剂(P<0.01)。MFNS耐受性良好,不良事件与安慰剂相当。

结论

MFNS能使季节性过敏性鼻炎患者迅速出现具有临床意义的症状缓解。

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