McDonald Stephen, Langton Hewer Claire D, Nunez Desmond A
ENT Department, St Michael's Hospital, University Hospitals Bristol NHS Trust, Southwell Street, Bristol, UK, BS2 8EG.
Cochrane Database Syst Rev. 2008 Oct 8(4):CD004741. doi: 10.1002/14651858.CD004741.pub2.
Acute suppurative otitis media is one of the most common infectious diseases in childhood. Recurrent acute otitis media is defined for the purposes of this review as either three or more acute infections of the middle ear cleft in a six-month period, or at least four episodes in a year. Strategies for managing the condition include the assessment and modification of risk factors where possible, repeated courses of antibiotics for each new infection, antibiotic prophylaxis and the insertion of ventilation tubes (grommets).
To establish whether ventilation tube insertion reduces the frequency of episodes of recurrent acute otitis media and the proportion of children with symptoms of ear disease.
We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1 2008), MEDLINE (1950 to 2008), EMBASE (1974 to 2008), CINAHL, mRCT (the metaRegister of Controlled Trials for ongoing/unpublished trials), NRR (National Research Register), LILACs, KoreaMed, IndMed, PakMediNet, Zetoc, ISI Proceedings and Cambridge Scientific Abstracts. Reference lists of articles retrieved from the electronic searches were scanned for further trials. Systematic reviews and other meta-analyses were also searched for and their reference lists scanned. Contact was sought with authors of published trials and other experts in the field. The date of the last search was March 2008.
No trials that included a treatment and a control group that met the inclusion criteria were excluded. Abstracts were screened and full text articles of studies that met our inclusion criteria obtained. Two authors independently applied the inclusion criteria. Studies included in the review underwent quality assessment performed independently by all authors adapting the methods outlined in the Cochrane Handbook for Systematic Reviews of Interventions.
Data were extracted independently by the authors and synthesised descriptively. Five randomised controlled trials were identified, of which two fulfilled the inclusion criteria.
Two studies involving 148 children were included in the review. One of these studies, involving 95 children, showed that ventilation tube insertion leads to a mean reduction of 1.5 episodes of acute otitis media in the first six months after treatment. This study also showed a significant increase in the proportion of children with no episodes of AOM (p < 0.001) in the ventilation tube group. The other included study also found a higher proportion of patients in the ventilation tube group had no episodes of AOM in the six months after intervention, but the difference did not reach statistical significance (p = 0.16).
AUTHORS' CONCLUSIONS: Ventilation tubes have a significant role in maintaining a 'disease-free' state in the first six months after insertion. Further research is required to investigate the effect beyond six months. Clinicians should consider the possible adverse effects of grommet insertion before surgery is undertaken.
急性化脓性中耳炎是儿童期最常见的传染病之一。本综述将复发性急性中耳炎定义为在六个月内中耳腔发生三次或更多次急性感染,或一年内至少发作四次。该病的治疗策略包括尽可能评估和改变危险因素、每次新感染时重复使用抗生素疗程、抗生素预防以及插入通气管(鼓膜切开置管)。
确定插入通气管是否能降低复发性急性中耳炎的发作频率以及患有耳部疾病症状儿童的比例。
我们检索了Cochrane耳、鼻、喉疾病组试验注册库、Cochrane对照试验中央注册库(CENTRAL)(《Cochrane图书馆》,2008年第1期)、MEDLINE(1950年至2008年)、EMBASE(1974年至2008年)、CINAHL、mRCT(正在进行/未发表试验的对照试验元注册库)、NRR(国家研究注册库)、LILACs、KoreaMed、IndMed、PakMediNet、Zetoc、ISI会议录和剑桥科学文摘。对从电子检索中获取的文章的参考文献列表进行筛选以寻找更多试验。还检索了系统评价和其他荟萃分析并扫描其参考文献列表。与已发表试验的作者及该领域的其他专家进行了联系。最后一次检索日期为2008年3月。
未排除任何包含符合入选标准的治疗组和对照组的试验。筛选摘要并获取符合我们入选标准的研究的全文文章。两位作者独立应用入选标准。纳入综述的研究由所有作者根据《Cochrane干预措施系统评价手册》中概述的方法独立进行质量评估。
作者独立提取数据并进行描述性综合。确定了五项随机对照试验,其中两项符合入选标准。
综述纳入了两项涉及148名儿童的研究。其中一项涉及95名儿童的研究表明,插入通气管后在前六个月内急性中耳炎发作次数平均减少1.5次。该研究还表明,通气管组中无急性中耳炎发作的儿童比例显著增加(p < 0.001)。另一项纳入研究也发现,通气管组中在干预后六个月内无急性中耳炎发作的患者比例更高,但差异未达到统计学意义(p = 0.16)。
通气管在插入后的前六个月维持“无疾病”状态方面具有重要作用。需要进一步研究以调查六个月以后的效果。临床医生在进行手术前应考虑鼓膜切开置管可能产生的不良反应。