Meltzer E O, Charous B L, Busse W W, Zinreich S J, Lorber R R, Danzig M R
Allergy & Asthma Medical Group & Research Center, A Professional Corporation, San Diego, CA, USA.
J Allergy Clin Immunol. 2000 Oct;106(4):630-7. doi: 10.1067/mai.2000.109056.
Intranasal glucocorticoids are effective in the treatment of allergic rhinitis. Their effectiveness as an anti-inflammatory adjunct in the treatment of acute recurrent sinusitis has not been adequately established in a controlled clinical study.
The purpose of this study was to test the hypothesis that intranasal corticosteroid treatment produces additional relief in the treatment of acute sinusitis with oral antibiotics.
Patients who were 12 years old and older with a history of recurrent sinusitis were treated while experiencing a new episode of acute sinusitis, which was diagnosed by symptoms and confirmed by computed tomography scan of the paranasal sinuses. Patients were treated for 21 days with amoxicillin clavulanate potassium and randomized to receive concurrent mometasone furoate nasal spray (MFNS; Nasonex [400 microg, twice daily]; n = 200 patients) or placebo spray (twice daily; n = 207 patients). Symptom scores for headache, facial pain, congestion, purulent rhinorrhea, postnasal drip, and cough were recorded at baseline and throughout treatment.
Baseline symptom scores showed a moderate level of symptom severity comparable in both groups. Patient-recorded twice daily symptom scores showed that adjunctive treatment with MFNS caused a significantly greater decrease in total symptom score (primary efficacy variable) and in individual scores of inflammatory symptoms associated with the obstruction process (headache, congestion, and facial pain) compared with placebo. Symptoms associated with the secretory processes were improved to a lesser degree. Therapy-related local adverse events were not significantly different between groups.
The addition of intranasal corticosteroid, MFNS 400 microg twice daily, to antibiotics significantly reduces symptoms of acute sinusitis compared with antibiotic treatment alone.
鼻内糖皮质激素对过敏性鼻炎有效。在一项对照临床研究中，其作为急性复发性鼻窦炎抗炎辅助治疗的有效性尚未得到充分证实。
本研究旨在验证以下假设，即鼻内皮质类固醇治疗对口服抗生素治疗急性鼻窦炎有额外的缓解作用。
年龄在12岁及以上且有复发性鼻窦炎病史的患者，在经历急性鼻窦炎新发作时接受治疗，急性鼻窦炎通过症状诊断，并经鼻窦计算机断层扫描确认。患者接受阿莫西林克拉维酸钾治疗21天，并随机分为两组，一组同时接受糠酸莫米松鼻喷雾剂（MFNS；内舒拿[400微克，每日两次]；n = 200例患者）治疗，另一组接受安慰剂喷雾剂（每日两次；n = 207例患者）治疗。在基线和整个治疗过程中记录头痛、面部疼痛、鼻塞、脓性鼻涕、鼻后滴漏和咳嗽的症状评分。
基线症状评分显示两组症状严重程度处于中等水平。患者记录的每日两次症状评分显示，与安慰剂相比，MFNS辅助治疗导致总症状评分（主要疗效变量）以及与阻塞过程相关的炎症症状（头痛、鼻塞和面部疼痛）的个体评分显著降低。与分泌过程相关的症状改善程度较小。两组之间与治疗相关的局部不良事件无显著差异。
与单独使用抗生素治疗相比，每日两次添加400微克MFNS鼻内皮质类固醇可显著减轻急性鼻窦炎的症状。
