Dalziel K, Stein K, Round A, Garside R, Royle P
Peninsula Technology Assessment Group, Exeter, UK.
Health Technol Assess. 2003;7(17):iii, 1-159. doi: 10.3310/hta7170.
To provide a systematic review of the clinical effectiveness of endoscopic sinus surgery (ESS) for the removal of nasal polyps.
Searches of electronic databases, websites and reference lists were made to identify relevant studies.
An extensive search was performed to identify all articles where FESS is used for the excision of nasal polyps. Two reviewers independently screened articles for inclusion according to predefined criteria. Comparative studies were included if they were primary research, focused on FESS for the removal of nasal polyps, reported patient relevant outcomes and were published in English. In addition, case series studies were included if they met the above criteria and enrolled more than 50 patients with polyps. Data were then extracted by one reviewer and checked by a second. A structured form was used to assess the internal and external validity of included studies. Comparative data were reported where available. Excluded case series and case reports were grouped and described. A group of nine ear, nose and throat (ENT) experts were selected, then using the literature and their own experience, they generated a list of priority research questions. Existing economic evaluations were sought and described.
Of the 33 studies included, the randomised controlled trials and controlled trials reported overall symptomatic improvement that ranged from 78 to 88% for FESS compared with 43 to 84% for similar techniques (including polypectomy, Caldwell-Luc and intranasal ethmoidectomy). Disease recurrence was 8% for FESS compared with 14% for Caldwell-Luc and polyp recurrence was 28% for endoscopic ethmoidectomy compared with 35% for polypectomy. Revision surgery was reported in one study only and was the same for FESS and Caldwell-Luc procedures. Percentage of overall complications was reported in only one comparative study and was 1.4% for FESS compared with 0.8% for conventional procedures. The case series studies reported overall symptomatic improvement for patients with nasal polyps ranging from 37 to 99% (median 89%). For the mixed patient groups (with and without polypoid disease) overall symptomatic improvement ranged from 40 to 98% (median 88%). Total complications in the case series studies ranged from 22.4 to 0.3% (median 6%).
The majority of studies report that symptoms improve following FESS with relatively few complications; however, only a small proportion of evidence is comparative. Results from non-comparative studies do not inform the choices that need to be made by ENT surgeons and commissioners. Health economics data are also lacking and therefore cannot inform these decisions. FESS may offer some advantages in effectiveness over comparative techniques, but there is enormous variation in the range of results reported and there are severe methodological limitations. There is a clear need for quality-controlled trials in order to answer questions regarding the effectiveness of FESS. A number of priority research questions from a selection of ENT surgeons within the UK are identified and presented.
对内镜鼻窦手术(ESS)切除鼻息肉的临床疗效进行系统评价。
检索电子数据库、网站及参考文献列表以识别相关研究。
进行广泛检索以识别所有使用功能性内镜鼻窦手术(FESS)切除鼻息肉的文章。两名评审员根据预定义标准独立筛选文章以纳入研究。如果比较研究是原发性研究、聚焦于FESS切除鼻息肉、报告了与患者相关的结局且以英文发表,则纳入。此外,如果病例系列研究符合上述标准且纳入了50例以上息肉患者,则纳入。然后由一名评审员提取数据并由另一名评审员检查。使用结构化表格评估纳入研究的内部和外部有效性。如有可用的比较数据,则进行报告。对排除的病例系列和病例报告进行分组并描述。挑选了一组9名耳鼻喉(ENT)专家,然后他们利用文献及自身经验,提出了一系列优先研究问题。查找并描述了现有的经济评估。
在纳入的33项研究中,随机对照试验和对照试验报告FESS术后总体症状改善率为78%至88%,而类似技术(包括息肉切除术、柯-陆氏手术和鼻内筛窦切除术)术后总体症状改善率为43%至84%。FESS术后疾病复发率为8%,柯-陆氏手术为14%,内镜筛窦切除术息肉复发率为28%,息肉切除术为35%。仅一项研究报告了翻修手术情况,FESS和柯-陆氏手术的翻修手术情况相同。仅一项比较研究报告了总体并发症发生率,FESS为1.4%,传统手术为0.8%。病例系列研究报告鼻息肉患者总体症状改善率为37%至99%(中位数89%)。对于混合患者组(有或无息肉样病变),总体症状改善率为40%至98%(中位数88%)。病例系列研究中总并发症发生率为2.4%至0.3%(中位数6%)。
大多数研究报告FESS术后症状改善,并发症相对较少;然而,只有一小部分证据是比较性的。非比较性研究的结果无法为耳鼻喉外科医生和医疗服务提供者做出的选择提供参考。健康经济学数据也很缺乏,因此无法为这些决策提供参考。与比较技术相比,FESS在有效性方面可能具有一些优势,但报告的结果范围存在巨大差异,且存在严重的方法学局限性。显然需要进行质量控制试验,以回答有关FESS有效性的问题。确定并呈现了来自英国部分耳鼻喉外科医生的一系列优先研究问题。