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用于无息肉慢性鼻-鼻窦炎的外用类固醇

Topical steroid for chronic rhinosinusitis without polyps.

作者信息

Snidvongs Kornkiat, Kalish Larry, Sacks Raymond, Craig Jonathan C, Harvey Richard J

机构信息

Australian School of Advanced Medicine, Macquarie University, Sydney, NSW, Australia.

出版信息

Cochrane Database Syst Rev. 2011 Aug 10(8):CD009274. doi: 10.1002/14651858.CD009274.

DOI:10.1002/14651858.CD009274
PMID:21833974
Abstract

BACKGROUND

Topical corticosteroid is used as part of a comprehensive medical treatment for chronic rhinosinusitis (CRS) without polyps. Nevertheless, there is insufficient evidence to show a clear overall benefit. Trials studying the efficacy of topical corticosteroid use various delivery methods in patients who have or have not had sinus surgery, which directly impacts on topical delivery and distribution.

OBJECTIVES

To assess the effects of topical steroid in patients with CRS without nasal polyps and perform a meta-analysis of symptom improvement data, including subgroup analysis by sinus surgery status and topical delivery methods.

SEARCH STRATEGY

We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ISRCTN and additional sources for published and unpublished trials. The date of the most recent search was 9 July 2010.

SELECTION CRITERIA

All randomised trials in which a topically administered corticosteroid was compared with either a placebo, no treatment or alternative topically administered corticosteroid for the treatment of CRS without polyps in patients of any age.

DATA COLLECTION AND ANALYSIS

Two authors reviewed the search results and selected trials meeting the eligibility criteria, obtaining full texts and contacting authors where necessary. We documented our justification for the exclusion of studies. Two authors extracted data using a pre-determined standardised data form.

MAIN RESULTS

Ten studies (590 patients) met the inclusion criteria. The trials were of low (six trials) and medium (four trials) risk of bias. The primary outcome was sino-nasal symptoms. When compared to placebo, topical steroid improved symptom scores (standardised mean difference -0.37; 95% confidence interval (CI) -0.60 to -0.13, P = 0.002; five trials, n = 286) and had a greater proportion of responders (risk ratio 1.69; 95% CI 1.21 to 2.37, P = 0.002; four trials, n = 263). With a limited number of studies, the subgroup analyses of patients who had received sinus surgery versus those who had not was not significant (P = 0.35). Subgroup analyses by topical delivery method revealed more benefit when steroid was administered directly to the sinuses than with simple nasal delivery (P = 0.04). There were no differences between groups for quality of life and adverse events.

AUTHORS' CONCLUSIONS: Topical steroid is a beneficial treatment for CRS without polyps and the adverse effects are minor. It may be included in a comprehensive treatment of CRS without polyps. Direct delivery of steroid to the sinuses may bring more beneficial effect. Further studies comparing different topical drug delivery methods to the sinuses, with appropriate treatment duration (longer than 12 weeks), are required.

摘要

背景

局部用皮质类固醇是慢性鼻-鼻窦炎(CRS,无息肉)综合药物治疗的一部分。然而,尚无充分证据表明其具有明确的总体益处。研究局部用皮质类固醇疗效的试验采用了多种给药方法,研究对象包括接受或未接受鼻窦手术的患者,而鼻窦手术会直接影响局部给药及药物分布。

目的

评估局部用类固醇对无鼻息肉的CRS患者的疗效,并对症状改善数据进行荟萃分析,包括按鼻窦手术状态和局部给药方法进行亚组分析。

检索策略

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);PubMed;EMBASE;CINAHL;科学引文索引;BIOSIS预评文摘;剑桥科学文摘;国际标准随机对照试验编号(ISRCTN)以及其他已发表和未发表试验的来源。最近一次检索日期为2010年7月9日。

选择标准

所有随机试验,其中将局部用皮质类固醇与安慰剂、未治疗或其他局部用皮质类固醇进行比较,用于治疗任何年龄无息肉的CRS患者。

数据收集与分析

两位作者回顾检索结果并选择符合纳入标准的试验,获取全文并在必要时联系作者。我们记录了排除研究的理由。两位作者使用预先确定的标准化数据表格提取数据。

主要结果

10项研究(590例患者)符合纳入标准。这些试验的偏倚风险为低(6项试验)和中(4项试验)。主要结局为鼻-鼻窦症状。与安慰剂相比,局部用类固醇改善了症状评分(标准化均数差-0.37;95%置信区间(CI)-0.60至-0.13,P = 0.002;5项试验,n = 286),且有更高比例的缓解者(风险比1.69;95%CI 1.21至2.37,P = 0.002;4项试验,n = 263)。由于研究数量有限,接受鼻窦手术与未接受鼻窦手术患者的亚组分析无显著差异(P = \alpha.35)。按局部给药方法进行的亚组分析显示,将类固醇直接注入鼻窦比单纯经鼻给药更有益(P = 0.04)。两组在生活质量和不良事件方面无差异。

作者结论

局部用类固醇是治疗无息肉CRS的有益疗法,且副作用较小。它可纳入无息肉CRS的综合治疗中。将类固醇直接注入鼻窦可能带来更有益的效果。需要进一步开展研究,比较不同的鼻窦局部给药方法,并采用适当的治疗疗程(超过12周)。

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