Allergy & Asthma Medical Group and Research Center, San Diego, California 92123, USA.
Ann Allergy Asthma Immunol. 2012 Apr;108(4):275-9. doi: 10.1016/j.anai.2012.01.015. Epub 2012 Feb 14.
Acute rhinosinusitis (ARS) is triggered by viral or, uncommonly, bacterial infection, causing inflammatory symptoms for ≤12 weeks.
To investigate effects of mometasone furoate nasal spray (MFNS) vs amoxicillin and placebo on minimal-symptom days.
A double-blind, parallel-group, placebo- and active-controlled 15-day study randomly assigned patients 12 years of age or older to MFNS 200 μg twice daily, MFNS 200 μg once daily, amoxicillin 500 mg 3 times daily, or placebo. Patients had baseline rhinosinusitis major symptom score (MSS; combined rhinorrhea, postnasal drip, congestion, sinus headache, facial pain) of ≥5 and ≤12 (maximum: 15) for 7 to 28 days; scores were similar among groups. Minimal-symptom days and minimal-congestion days were defined post hoc by average am/pm MSS ≤4 and average AM/PM congestion ≤1.
MFNS twice daily (n = 234) showed more minimal-symptom days vs placebo (n = 246) (62.69% vs 50.33%; P < .0001) or amoxicillin (n = 248) (54.35%; P = .0040). The MFNS QD was associated with numerically more minimal-symptom days than amoxicillin or placebo (54.72%; P ≤ .8982). MFNS was associated with more minimal-congestion days than placebo (72.97%, 67.73%, and 56.67% for twice daily, once daily, and placebo; P < .0001, each vs placebo) and MFNS BID with more minimal-congestion days than amoxicillin (72.97% vs 64.15%; P = .0007). Median time to first minimal-symptom day sustained until study end was 8.5 days for MFNS BID vs. 11 for placebo (P = .0085).
MFNS 200 μg twice daily significantly increased minimal-symptom days vs amoxicillin or placebo in patients with ARS. Results of this intranasal corticosteroids (INS) therapy indicate it can improve outcomes and potentially reduce inappropriate antibiotic use.
急性鼻-鼻窦炎(ARS)由病毒或罕见的细菌感染引发,引起炎症症状持续≤12 周。
研究糠酸莫米松鼻喷雾剂(MFNS)与阿莫西林和安慰剂对最小症状天数的影响。
一项双盲、平行组、安慰剂和阳性对照的 15 天研究,将 12 岁及以上的患者随机分配至 MFNS 200μg,每日两次;MFNS 200μg,每日一次;阿莫西林 500mg,每日三次;或安慰剂。患者基线时的鼻-鼻窦炎主要症状评分(MSS;综合鼻塞、后鼻滴注、充血、鼻窦头痛、面部疼痛)≥5 分且≤12 分(最高:15 分),持续 7-28 天;组间评分相似。最小症状天数和最小充血天数定义为平均 AM/PM MSS≤4 和平均 AM/PM 充血≤1。
MFNS 每日两次(n=234)组的最小症状天数多于安慰剂组(n=246)(62.69% vs 50.33%;P<.0001)或阿莫西林组(n=248)(54.35%;P=.0040)。MFNS QD 与阿莫西林或安慰剂相比,具有更多的最小症状天数(54.72%,P≤.8982)。MFNS 与安慰剂相比,具有更多的最小充血天数(72.97%、67.73%和 56.67%,每日两次、每日一次和安慰剂;P<.0001,每次与安慰剂相比),MFNS 每日两次与阿莫西林相比,具有更多的最小充血天数(72.97% vs 64.15%;P=.0007)。MFNS 每日两次组首次持续至研究结束的最小症状天数中位数为 8.5 天,安慰剂组为 11 天(P=.0085)。
MFNS 200μg,每日两次在 ARS 患者中,与阿莫西林或安慰剂相比,显著增加最小症状天数。这种鼻腔皮质类固醇(INS)治疗的结果表明,它可以改善结果并可能减少不合理的抗生素使用。