Lemiengre Marieke B, van Driel Mieke L, Merenstein Dan, Liira Helena, Mäkelä Marjukka, De Sutter An Im
Department of Family Medicine and Primary Health Care, Ghent University, Campus UZ 6K3, Corneel Heymanslaan 10, Ghent, Belgium, 9000.
Cochrane Database Syst Rev. 2018 Sep 10;9(9):CD006089. doi: 10.1002/14651858.CD006089.pub5.
Acute rhinosinusitis is an acute infection of the nasal passages and paranasal sinuses that lasts less than four weeks. Diagnosis of acute rhinosinusitis is generally based on clinical signs and symptoms in ambulatory care settings. Technical investigations are not routinely performed, nor are they recommended in most countries. Some trials show a trend in favour of antibiotics, but the balance of benefit versus harm is unclear.We merged two Cochrane Reviews for this update, which comprised different approaches with overlapping populations, resulting in different conclusions. For this review update, we maintained the distinction between populations diagnosed by clinical signs and symptoms, or imaging.
To assess the effects of antibiotics versus placebo or no treatment in adults with acute rhinosinusitis in ambulatory care settings.
We searched CENTRAL (2017, Issue 12), which contains the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (January 1950 to January 2018), Embase (January 1974 to January 2018), and two trials registers (January 2018). We also checked references from identified trials, systematic reviews, and relevant guidelines.
Randomised controlled trials of antibiotics versus placebo or no treatment in people with rhinosinusitis-like signs or symptoms or sinusitis confirmed by imaging.
Two review authors independently extracted data about cure and side effects and assessed the risk of bias. We contacted trial authors for additional information as required.
We included 15 trials involving 3057 participants. Of the 15 included trials, 10 appeared in our 2012 review, and five (631 participants) are legacy trials from merging two reviews. No new studies were included from searches for this update. Overall, risk of bias was low. Without antibiotics, 46% of participants with rhinosinusitis, whether or not confirmed by radiography, were cured after 1 week and 64% after 14 days. Antibiotics can shorten time to cure, but only 5 to 11 more people per 100 will be cured faster if they receive antibiotics instead of placebo or no treatment: clinical diagnosis (odds ratio (OR) 1.25, 95% confidence interval (CI) 1.02 to 1.54; number needed to treat for an additional beneficial outcome (NNTB) 19, 95% CI 10 to 205; I² = 0%; 8 trials; high-quality evidence) and diagnosis confirmed by radiography (OR 1.57, 95% CI 1.03 to 2.39; NNTB 10, 95% CI 5 to 136; I² = 0%; 3 trials; moderate-quality evidence). Cure rates with antibiotics were higher when a fluid level or total opacification in any sinus was found on computed tomography (OR 4.89, 95% CI 1.75 to 13.72; NNTB 4, 95% CI 2 to 15; 1 trial; moderate-quality evidence). Purulent secretion resolved faster with antibiotics (OR 1.58, 95% CI 1.13 to 2.22; NNTB 10, 95% CI 6 to 35; I² = 0%; 3 trials; high-quality evidence). However, 13 more people experienced side effects with antibiotics compared to placebo or no treatment (OR 2.21, 95% CI 1.74 to 2.82; number needed to treat for an additional harmful outcome (NNTH) 8, 95% CI 6 to 12; I² = 16%; 10 trials; high-quality evidence). Five fewer people per 100 will experience clinical failure if they receive antibiotics instead of placebo or no treatment (Peto OR 0.48, 95% CI 0.36 to 0.63; NNTH 19, 95% CI 15 to 27; I² = 21%; 12 trials; high-quality evidence). A disease-related complication (brain abscess) occurred in one participant (of 3057) one week after receiving open antibiotic therapy (clinical failure, control group).
AUTHORS' CONCLUSIONS: The potential benefit of antibiotics to treat acute rhinosinusitis diagnosed either clinically (low risk of bias, high-quality evidence) or confirmed by imaging (low to unclear risk of bias, moderate-quality evidence) is marginal and needs to be seen in the context of the risk of adverse effects. Considering antibiotic resistance, and the very low incidence of serious complications, we conclude there is no place for antibiotics for people with uncomplicated acute rhinosinusitis. We could not draw conclusions about children, people with suppressed immune systems, and those with severe sinusitis, because these populations were not included in the available trials.
急性鼻窦炎是鼻腔和鼻窦的急性感染,病程持续少于四周。在门诊环境中,急性鼻窦炎的诊断通常基于临床体征和症状。一般不进行技术检查,大多数国家也不推荐。一些试验显示了支持使用抗生素的趋势,但利弊平衡尚不清楚。本次更新我们合并了两项Cochrane系统评价,这两项评价采用了不同的方法且研究人群有重叠,导致结论不同。对于本次评价更新,我们保持了通过临床体征和症状诊断的人群与通过影像学诊断的人群之间的区分。
评估在门诊环境中,抗生素对比安慰剂或不治疗对成人急性鼻窦炎的影响。
我们检索了Cochrane系统评价中心注册库(CENTRAL,2017年第12期),其中包含Cochrane急性呼吸道感染小组的专业注册库、MEDLINE(1950年1月至2018年1月)、Embase(1974年1月至2018年1月)以及两个试验注册库(2018年1月)。我们还检查了已识别试验、系统评价及相关指南的参考文献。
关于抗生素对比安慰剂或不治疗,针对有鼻窦炎样体征或症状或经影像学证实为鼻窦炎患者的随机对照试验。
两名评价作者独立提取关于治愈和副作用的数据,并评估偏倚风险。我们根据需要联系试验作者获取更多信息。
我们纳入了15项试验,共3057名参与者。在纳入的15项试验中,10项出现在我们2012年的评价中,5项(631名参与者)是合并两项评价后的遗留试验。本次更新检索未纳入新的研究。总体而言,偏倚风险较低。不使用抗生素时,无论是否经影像学证实,46%的鼻窦炎参与者在1周后治愈,64%在14天后治愈。抗生素可缩短治愈时间,但每100人中接受抗生素治疗而非安慰剂或不治疗的情况下,仅多5至11人能更快治愈:临床诊断(比值比(OR)1.25,95%置信区间(CI)1.02至1.54;为获得额外有益结果所需治疗人数(NNTB)19,95%CI 10至205;I² = 0%;8项试验;高质量证据)以及经影像学证实的诊断(OR 1.57,95%CI 1.03至2.39;NNTB 10,95%CI 5至136;I² = 0%;3项试验;中等质量证据)。当计算机断层扫描发现任何鼻窦有液平面或完全混浊时,使用抗生素的治愈率更高(OR 4.89,95%CI 1.75至13.72;NNTB 4,95%CI 2至15;1项试验;中等质量证据)。使用抗生素时脓性分泌物消散更快(OR 1.58,95%CI 1.13至2.22;NNTB 10,95%CI 6至35;I² = 0%;3项试验;高质量证据)。然而,与安慰剂或不治疗相比,使用抗生素多13人出现副作用(OR 2.21,95%CI 1.74至2.82;为获得额外有害结果所需治疗人数(NNTH)8,95%CI 6至12;I² = 16%;10项试验;高质量证据)。每100人中接受抗生素治疗而非安慰剂或不治疗的情况下,临床失败的人数少5人(Peto比值比0.48,95%CI 0.36至0.63;NNTH 19,95%CI 15至27;I² = 21%;12项试验;高质量证据)。一名参与者(3057名中的)在接受开放抗生素治疗(临床失败,对照组)一周后发生了与疾病相关的并发症(脑脓肿)。
抗生素治疗临床诊断(偏倚风险低,高质量证据)或经影像学证实(偏倚风险低至不明确,中等质量证据)的急性鼻窦炎的潜在益处微乎其微,且需结合不良反应风险来看。考虑到抗生素耐药性以及严重并发症的极低发生率,我们得出结论,对于无并发症的急性鼻窦炎患者,抗生素并无用武之地。我们无法就儿童、免疫系统受抑制的人群以及重症鼻窦炎患者得出结论,因为现有试验未纳入这些人群。