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咽鼓管功能障碍治疗有限证据基础的系统评价:一项卫生技术评估

Systematic review of the limited evidence base for treatments of Eustachian tube dysfunction: a health technology assessment.

作者信息

Norman G, Llewellyn A, Harden M, Coatesworth A, Kimberling D, Schilder A, McDaid C

机构信息

Centre for Reviews and Dissemination, University of York, York, UK.

出版信息

Clin Otolaryngol. 2014 Feb;39(1):6-21. doi: 10.1111/coa.12220.

Abstract

BACKGROUND

The Health Technology Assessment programme commissioned a wide-ranging review of treatments for adult Eustachian tube dysfunction. Treatments range from advice and observation and pharmacological treatments to surgical options.

OBJECTIVE

(i) To assess the evidence for interventions for adults with a clinical diagnosis of Eustachian tube dysfunction and (ii) to identify priorities for future research.

TYPE OF REVIEW

Systematic review (PROSPERO registration CRD42012003035) adhering to PRISMA guidance.

SEARCH

An extensive search of 15 databases including MEDLINE, EMBASE and CENTRAL (up to October 2012).

EVALUATION METHOD

Controlled and uncontrolled studies of interventions for adult Eustachian tube dysfunction were included. Because of insufficient data, the protocol was amended to also include controlled studies with mixed adult/child populations. Risk of bias was assessed. Narrative synthesis was employed due to high clinical heterogeneity.

RESULTS

Interventions assessed were pharmacological treatments [two randomised controlled trials (RCTs), one controlled non-randomised trial (CCT), 159 patients]; mechanical pressure equalisation devices (one randomised controlled trial, one CCT, 48 patients); and surgery, including laser tuboplasty (seven case series, 192 patients), balloon dilatation (three case series, 103 patients), myringotomy without grommet insertion (two case series, 121 patients), transtubal steroids (one case series, 11 patients) and laser coagulation (one retrospective controlled study, 40 patients). All studies had high risk of bias except two pharmacological trials; one had low risk and one unclear risk. No evidence was found for many treatments. The single low risk of bias RCT (n = 91; 67% adults) showed no effect of nasal steroids and favoured placebo for improved middle ear function (RR 1.20, 95% CI 0.91-1.58) and symptoms (P = 0.07). Other studies showed improvements in middle ear function for mechanical devices, antihistamine/ephedrine and nasal decongestant, but they had significant methodological weaknesses including insufficient length of follow-up. None of the surgical studies were adequately controlled, and many reported high levels of co-intervention. Therefore, observed benefits for tuboplasty and balloon dilatation in symptoms, middle ear function or hearing could not be reliably attributed to the interventions assessed. There was variability in definitions of the condition.

CONCLUSION

Eustachian tube dysfunction is a poorly defined condition. Due to the limited and poor-quality evidence, it is inappropriate to make conclusions on the effectiveness of any intervention; the evidence base is insufficient to guide recommendations for a trial of any particular intervention. Consensus on diagnostic criteria for Eustachian tube dysfunction is required to inform inclusion criteria of future trials.

摘要

背景

卫生技术评估项目委托开展了一项关于成人咽鼓管功能障碍治疗方法的广泛综述。治疗方法包括建议与观察、药物治疗以及手术选择。

目的

(i)评估针对临床诊断为咽鼓管功能障碍的成人进行干预的证据,以及(ii)确定未来研究的重点。

综述类型

遵循PRISMA指南的系统综述(PROSPERO注册号CRD42012003035)。

检索

对15个数据库进行广泛检索,包括MEDLINE、EMBASE和CENTRAL(截至2012年10月)。

评估方法

纳入了针对成人咽鼓管功能障碍干预措施的对照和非对照研究。由于数据不足,对方案进行了修订,还纳入了成人/儿童混合人群的对照研究。评估了偏倚风险。由于临床异质性高,采用了叙述性综合分析。

结果

评估的干预措施包括药物治疗[两项随机对照试验(RCT)、一项非随机对照试验(CCT),159例患者];机械压力平衡装置(一项随机对照试验、一项CCT,48例患者);以及手术,包括激光咽鼓管成形术(七个病例系列,192例患者)、球囊扩张术(三个病例系列,103例患者)、鼓膜切开术但不插入通气管(两个病例系列,121例患者)、经咽鼓管类固醇注射(一个病例系列,11例患者)和激光凝固术(一项回顾性对照研究,40例患者)。除两项药物试验外,所有研究均有较高的偏倚风险;一项偏倚风险低,一项偏倚风险不明确。未发现许多治疗方法的证据。唯一一项偏倚风险低的RCT(n = 91;67%为成人)显示鼻用类固醇无效果,且在改善中耳功能(RR 1.20,95% CI 0.91 - 1.58)和症状方面更倾向于安慰剂(P = 0.07)。其他研究显示机械装置、抗组胺药/麻黄碱和鼻减充血剂可改善中耳功能,但存在显著的方法学缺陷,包括随访时间不足。没有一项手术研究得到充分对照,许多研究报告了高水平的联合干预。因此,观察到的咽鼓管成形术和球囊扩张术在症状、中耳功能或听力方面的益处不能可靠地归因于所评估的干预措施。该病症的定义存在差异。

结论

咽鼓管功能障碍是一种定义不明确的病症。由于证据有限且质量差,就任何干预措施的有效性得出结论是不合适的;证据基础不足以指导关于任何特定干预试验的建议。需要就咽鼓管功能障碍的诊断标准达成共识,以为未来试验的纳入标准提供依据。

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