Division of General Medical Sciences, Washington University School of Medicine, Campus Box 8005, 660 S Euclid Ave, St Louis, MO 63110, USA.
JAMA. 2012 Feb 15;307(7):685-92. doi: 10.1001/jama.2012.138.
Evidence to support antibiotic treatment for acute rhinosinusitis is limited, yet antibiotics are commonly used.
To determine the incremental effect of amoxicillin treatment over symptomatic treatments for adults with clinically diagnosed acute rhinosinusitis.
DESIGN, SETTING, AND PARTICIPANTS: A randomized, placebo-controlled trial of adults with uncomplicated, acute rhinosinusitis were recruited from 10 community practices in Missouri between November 1, 2006, and May 1, 2009.
Ten-day course of either amoxicillin (1500 mg/d) or placebo administered in 3 doses per day. All patients received a 5- to 7-day supply of symptomatic treatments for pain, fever, cough, and nasal congestion to use as needed.
The primary outcome was improvement in disease-specific quality of life after 3 to 4 days of treatment assessed with the Sinonasal Outcome Test-16 (minimally important difference of 0.5 units on a 0-3 scale). Secondary outcomes included the patient's retrospective assessment of change in sinus symptoms and functional status, recurrence or relapse, and satisfaction with and adverse effects of treatment. Outcomes were assessed by telephone interview at days 3, 7, 10, and 28.
A total of 166 adults (36% male; 78% with white race) were randomized to amoxicillin (n = 85) or placebo (n = 81); 92% concurrently used 1 or more symptomatic treatments (94% for amoxicillin group vs 90% for control group; P = .34). The mean change in Sinonasal Outcome Test-16 scores was not significantly different between groups on day 3 (decrease of 0.59 in the amoxicillin group and 0.54 in the control group; mean difference between groups of 0.03 [95% CI, -0.12 to 0.19]) and on day 10 (mean difference between groups of 0.01 [95% CI, -0.13 to 0.15]), but differed at day 7 favoring amoxicillin (mean difference between groups of 0.19 [95% CI, 0.024 to 0.35]). There was no statistically significant difference in reported symptom improvement at day 3 (37% for amoxicillin group vs 34% for control group; P = .67) or at day 10 (78% vs 80%, respectively; P = .71), whereas at day 7 more participants treated with amoxicillin reported symptom improvement (74% vs 56%, respectively; P = .02). No between-group differences were found for any other secondary outcomes. No serious adverse events occurred.
Among patients with acute rhinosinusitis, a 10-day course of amoxicillin compared with placebo did not reduce symptoms at day 3 of treatment.
clinicaltrials.gov Identifier: NCT00377403.
支持急性鼻-鼻窦炎使用抗生素治疗的证据有限，但抗生素仍被广泛应用。
确定阿莫西林治疗对有临床诊断的急性鼻-鼻窦炎的成年人相对于对症治疗的附加疗效。
设计、地点和参与者：2006 年 11 月 1 日至 2009 年 5 月 1 日，在密苏里州的 10 个社区实践中招募了患有单纯性、急性鼻-鼻窦炎的成年人，进行了一项随机、安慰剂对照试验。
接受为期 10 天的阿莫西林（1500mg/d）或安慰剂治疗，每天 3 次。所有患者都接受了 5-7 天的疼痛、发热、咳嗽和鼻塞对症治疗，按需使用。
主要结局是使用鼻-鼻窦炎结局测试-16（0-3 分制，最小重要差异为 0.5 分）在治疗后 3-4 天评估的疾病特异性生活质量改善。次要结局包括患者对窦症状和功能状态变化的回顾性评估、复发或复发、对治疗的满意度和不良反应。通过电话访谈在第 3、7、10 和 28 天评估结果。
共有 166 名成年人（36%为男性；78%为白人）被随机分配到阿莫西林（n=85）或安慰剂（n=81）组；92%的人同时使用了 1 种或多种对症治疗（阿莫西林组为 94%，对照组为 90%；P=0.34）。第 3 天，阿莫西林组和对照组的鼻-鼻窦炎结局测试-16 评分变化的组间差异无统计学意义（阿莫西林组下降 0.59，对照组下降 0.54；组间平均差异为 0.03[95%CI，-0.12 至 0.19]），第 10 天也无统计学意义（组间平均差异为 0.01[95%CI，-0.13 至 0.15]），但第 7 天阿莫西林组更有利（组间平均差异为 0.19[95%CI，0.024 至 0.35]）。第 3 天（阿莫西林组 37%，对照组 34%；P=0.67）和第 10 天（分别为 78%和 80%；P=0.71）报告症状改善的患者差异无统计学意义，而第 7 天接受阿莫西林治疗的患者报告症状改善的比例更高（分别为 74%和 56%；P=0.02）。其他次要结局在组间无差异。未发生严重不良事件。
在急性鼻-鼻窦炎患者中，与安慰剂相比，10 天疗程的阿莫西林并未在治疗第 3 天减轻症状。
clinicaltrials.gov 标识符：NCT00377403。
