Williamson Ian G, Rumsby Kate, Benge Sarah, Moore Michael, Smith Peter W, Cross Martine, Little Paul
Department of Medicine, University of Southampton, Southampton, England.
JAMA. 2007 Dec 5;298(21):2487-96. doi: 10.1001/jama.298.21.2487.
Acute sinusitis is a common clinical problem that usually results in a prescription for antibiotics but the role of antibiotics is debated. Anti-inflammatory drugs such as topical steroids may be beneficial but are underresearched.
To determine the effectiveness of amoxicillin and topical budesonide in acute maxillary sinusitis.
DESIGN, SETTING, AND PATIENTS: A double-blind, randomized, placebo-controlled factorial trial of 240 adults (aged > or =16 years) with acute nonrecurrent sinusitis (had > or =2 diagnostic criteria: purulent rhinorrhea with unilateral predominance, local pain with unilateral predominance, purulent rhinorrhea bilateral, presence of pus in the nasal cavity) at 58 family practices (74 family physicians) between November 2001 and November 2005. Patients were randomized to 1 of 4 treatment groups: antibiotic and nasal steroid; placebo antibiotic and nasal steroid; antibiotic and placebo nasal steroid; placebo antibiotic and placebo nasal steroid.
A dose of 500 mg of amoxicillin 3 times per day for 7 days and 200 mug of budesonide in each nostril once per day for 10 days.
Proportion clinically cured at day 10 using patient symptom diaries and the duration and severity of symptoms.
The proportions of patients with symptoms lasting 10 or more days were 29 of 100 (29%) for amoxicillin vs 36 of 107 (33.6%) for no amoxicillin (adjusted odds ratio, 0.99; 95% confidence interval, 0.57-1.73). The proportions of patients with symptoms lasting 10 or more days were 32 of 102 (31.4%) for topical budesonide vs 33 of 105 (31.4%) for no budesonide (adjusted odds ratio, 0.93; 95% confidence interval, 0.54-1.62). Secondary analysis suggested that nasal steroids were significantly more effective in patients with less severe symptoms at baseline.
Neither an antibiotic nor a topical steroid alone or in combination was effective as a treatment for acute sinusitis in the primary care setting.
isrctn.org Identifier: ISRCTN60825437.
急性鼻窦炎是常见的临床问题，通常会开具抗生素处方，但抗生素的作用存在争议。局部用类固醇等抗炎药物可能有益，但相关研究较少。
确定阿莫西林和布地奈德局部用药治疗急性上颌窦炎的有效性。
设计、地点和患者：一项双盲、随机、安慰剂对照析因试验，纳入240例年龄≥16岁、患有急性非复发性鼻窦炎（具备≥2项诊断标准：单侧为主的脓性鼻涕、单侧为主的局部疼痛、双侧脓性鼻涕、鼻腔有脓）的成年人，于2001年11月至2005年11月期间在58家家庭诊所（74名家庭医生处）进行。患者被随机分为4个治疗组之一：抗生素加鼻用类固醇；安慰剂抗生素加鼻用类固醇；抗生素加安慰剂鼻用类固醇；安慰剂抗生素加安慰剂鼻用类固醇。
阿莫西林500mg，每日3次，共7天；布地奈德200μg，每个鼻孔每日1次，共10天。
使用患者症状日记评估第10天时临床治愈的比例以及症状的持续时间和严重程度。
症状持续10天或更长时间的患者比例，使用阿莫西林组为100例中的29例（29%），未使用阿莫西林组为107例中的36例（33.6%）（调整优势比为0.99；95%置信区间为0.57 - 1.73）。症状持续10天或更长时间的患者比例，使用布地奈德局部用药组为102例中的32例（31.4%），未使用布地奈德组为105例中的33例（31.4%）（调整优势比为0.93；95%置信区间为0.54 - 1.62）。二次分析表明，鼻用类固醇对基线症状较轻的患者疗效显著更佳。
在初级保健环境中，单独使用抗生素或局部用类固醇，或两者联合使用，均不能有效治疗急性鼻窦炎。
isrctn.org标识符：ISRCTN60825437。
